SecProbe.io

CORRESP
 1
 filename1.htm

 Jyong Biotech Ltd.

 23F-3, No. 95, Section 1, Xintai 5th Road

 Xizhi District, New Taipei City

 Taiwan, 221

 June 12, 2025

 VIA EDGAR

 United States Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, D.C. 20549

 Attention: Ms. Doris Stacey Gama/ Ms. Suzanne Hayes

 Re:
 Jyong Biotech Ltd.

 Post-Effective Amendment No. 2 to Registration Statement on Form F-1

 File No. 333-277725

 Ladies and Gentlemen:

 Pursuant to Rule 461 under
the Securities Act of 1933, as amended (the " Act "), Jyong Biotech Ltd. (the " Company ") respectfully
requests that the effective date of the registration statement referred to above (the " Registration Statement ") be
accelerated so that it will become effective at 4:00 p.m., Eastern Time, on Monday, June 16, 2025, or as soon thereafter as possible.
In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.

 Once the Registration Statement
is effective, please orally confirm the event with our counsel, Sichenzia Ross Ference Carmel LLP by calling Shane Wu, Esq. at (202) 322-8852.
We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time
and date of the Registration Statement be sent to our counsel, Sichenzia Ross Ference Carmel LLP, Attention: Shane Wu, Esq, by email at
 swu@srfc.law and Tomer Magid, by email at tmagid@srfc.law .

 If you have any questions
regarding this request, please contact Shane Wu, Esq. of Sichenzia Ross Ference Carmel LLP, at (202) 322-8852.

 Very Truly Yours,

 By:
 /s/ Fu-Feng Kuo

 Name:
 Fu-Feng Kuo

 Title:
 Chief Executive Officer

 cc:
 Shane Wu, Esq. of Sichenzia Ross Ference Carmel LLP

CORRESP
 1
 filename1.htm

 Joseph Stone Capital, LLC

 Via EDGAR

 June 12, 2025

 Division of Corporation Finance

 Office of Life Sciences

 U.S. Securities and Exchange Commission

 100 F Street, NE

 Washington, D.C., 20549

 Attention:
 Doris Stacey

 Suzanne Hayes
 Ibolya Ignat
 Mary Mast

 Re:
 Jyong Biotech Ltd.

 Registration Statement on Form F-1, as amended

 Initially Filed on March 7, 2024

 File No. 333-277725

 Ladies and Gentlemen:

 Pursuant
to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended,
Joseph Stone Capital, LLC, as the representative of underwriters, hereby requests acceleration of the effective date of the above-referenced
Registration Statement so that it will become effective at 4:00 p.m., Eastern Time, on June
16, 2025 , or as soon thereafter as practicable.

 Pursuant
to Rule 460 under the Securities Act, we wish to advise you that we will take reasonable steps to secure adequate distribution of the
preliminary prospectus to underwriters, dealers, institutions and others prior to the requested effective time of the Registration Statement.

 We have been advised
by the prospective underwriters that they have complied and will continue to comply with the requirements of Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended.

 Very truly yours,

 Joseph Stone Capital, LLC

 By:
 /s/Damian Maggio

 Name:
 Damian Maggio

 Title:
 Chief Executive Officer

CORRESP
 1
 filename1.htm

 Jyong Biotech Ltd.

 23F-3, No. 95, Section 1, Xintai 5th Road

 Xizhi District, New Taipei City

 Taiwan, 221

 March 28, 2025

 VIA EDGAR

 United States Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, D.C. 20549

 Attention: Ms. Doris Stacey Gama/ Ms. Suzanne Hayes

 Re:
 Jyong Biotech Ltd.

 Registration Statement on Form F-1, as amended

 File No. 333-277725

 Ladies and Gentlemen:

 Pursuant to Rule 461 under
the Securities Act of 1933, as amended (the " Act "), Jyong Biotech Ltd. (the " Company ") respectfully
requests that the effective date of the registration statement referred to above (the " Registration Statement ") be
accelerated so that it will become effective at 4:00 p.m., Eastern Time, on Monday, March 31, 2025, or as soon thereafter as possible.
In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act.

 Once the Registration Statement
is effective, please orally confirm the event with our counsel, Sichenzia Ross Ference Carmel LLP by calling Shane Wu, Esq. at (202) 322-8852.
We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time
and date of the Registration Statement be sent to our counsel, Sichenzia Ross Ference Carmel LLP, Attention: Shane Wu, Esq, by email at
 swu@srfc.law .

 If you have any questions
regarding this request, please contact Shane Wu, Esq. of Sichenzia Ross Ference Carmel LLP, at (202) 322-8852.

 Very Truly Yours,

 By:
 /s/ Fu-Feng Kuo

 Name:
 Fu-Feng Kuo

 Title:
 Chief Executive Officer

 cc:
 Shane Wu, Esq. of Sichenzia Ross Ference Carmel LLP

CORRESP
 1
 filename1.htm

 Joseph Stone Capital, LLC

 March 28, 2025

 VIA EDGAR

 United States Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

 Washington, D.C. 20549

 Attention: Ms. Doris Stacey Gama/ Ms. Suzanne Hayes

 Re:
 Jyong Biotech Ltd.

 Registration Statement on Form F-1, as amended

 File No. 333-277725

 Ladies and Gentlemen:

 Pursuant to Rule 461 under the Securities Act of
1933, as amended (the "Act"), as the underwriter of the proposed offering of Jyong Biotech Ltd. (the "Company"),
we hereby join the Company's request for acceleration of the above-referenced Registration Statement, requesting effectiveness for
4:00 p.m., Eastern Time, on Monday, March 31, 2025, or as soon thereafter as is practicable.

 Pursuant to Rule 460 under the Act, as the representative
of the several underwriters, we wish to advise you that we have distributed to each underwriter and dealer who is reasonably anticipated
to participate in the distribution of the security to be offered a sufficient number of copies of the preliminary prospectus permitted
by Rule 430 under the Act as it appears to be reasonable to secure their adequate distribution.

 The undersigned advises that it has complied and
will continue to comply with the requirements of Rule 15c2-8 under the Securities and Exchange Act of 1934, as amended.

 Very Truly Yours,

 Joseph Stone Capital, LLC

 By:
 /s/ Damian Maggio

 Name:
 Damian Maggio

 Title:
 Chief Executive Officer

 cc:
 Fang Liu, Esq. of VCL Law LLP

CORRESP
1
filename1.htm

December
18, 2024

Via
EDGAR

Division
of Corporation Finance

Office
of Life Sciences

Securities
and Exchange Commission

Washington,
D.C. 20549

    Attn.:
    Ibolya Ignat

Mary
Mast

Doris
Stacey Gama

Joe
McCann

    Re:
    Jyong
    Biotech Ltd.

    Response to the Staff’s Comments on

    Registration
    Statement on Form F-1/A

    Filed
    on November 21, 2024 (File No. 333-277725)

Dear
Sir and Madam:

On
behalf of our client, Jyong Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff
(the “Staff”) of the Securities and Exchanges Commission (the “Commission”) this letter setting
forth the Company’s responses to the comments contained in the Staff’s letter dated December 5, 2024 on the Company’s
registration statement on Form F-1/A filed on November 21, 2024 (the “Registration Statement”). Concurrently
with the submission of this letter, the Company is filing amendment No.8 to Registration Statement (the “Amendment No.8”)
via EDGAR to the Commission.

The
Staff’s comments are repeated below in bold and are followed by the Company’s responses. We have included page references
in the Amendment No.7 where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein
have the meanings set forth in the Amendment No.8.

Our
Drug Candidates

MCS-2

Phase
III Clinical Studies, page 127

1. We
                                            note your response to prior comment 5 on page 27 regarding the “possibly related”
                                            but not “definitely related” pancreatitis event observed in the MCS-2-US-c trial.
                                            Please also include this disclosure in this section, where applicable.

Response:
There are no pancreatitis events classified as “definitely related.” In response to the Staff’s comments, the Company
has revised the disclosure on page 132 of the Amendment No.8.

Legal
Proceedings and Compliance Taizhou

Investment Dispute, page 145

2. In
                                            response to prior comment 6 you state that under PRC civil procedure, the parties at any
                                            time before and during the enforcement procedure and until such enforcement procedure it
                                            completed, may choose to enter into a settlement agreement. Please clarify if during the
                                            enforcement procedure the company is required to make payments towards the judgement. If
                                            so, please also state the amounts expected to be paid and whether there is a payment plan
                                            or similar agreement in place.

Response:
In response to the Staff’s comments, the Company has revised the disclosure on page 145 of the Amendment No.8.

Legal
Matters, page 203

3. You
state that “[c]ertain legal matters limited to the regulatory history of MCS-2 before the U.S. Food and Drug Administration (FDA)
will be passed upon for us by Olsson Frank Weeda Terman Matz PC.” Please clarify if “regulatory history” represents a
specific date range or all the MCS-2 regulatory process to date. If there is a date range, please include the range. Further, please
file a consent from Olsson Frank Weeda Terman Matz PC or otherwise state why you do not believe a consent is required. Please see Rule
436 of the Securities Act of 1933. Similarly identify the legal matters as to Taiwan law that will be passed upon by KPMG Law Firm and
provide its consent or explain why you believe a consent is not required.

Response:
KPMG law omly provided opinion on non-FDA related Taiwan laws of general application. In response to the Staff’s comments, the
Company has revised the disclosure on page 203 of the Amendment No.8. We have also attached Olsson Frank Weeda Terman Matz PC’s
legal opinion in exhibit 5.2.

Exhibit
5.1 Legal Opinion, page II-3

4. Please
                                            note it is inappropriate to include assumptions in your legal opinion that are overly broad
                                            or assume any material facts underlying the issue or any readily ascertainable facts. While
                                            it is permissible to assume that resolutions that were passed will remain in full force and
                                            will not be rescinded or amended, it is not appropriate to assume that Resolutions were passed
                                            at duly convened, constituted and quorate meetings or by unanimous resolutions as such assumption
                                            is an ascertainable fact and is material to the underlying issue. Please revise Assumption
                                            2.4 accordingly.

Response: In response to the Staff’s comments, Conyers Dill & Pearman (“Conyers”) clarified that
Assumption 2.4 is a standard assumption included in their opinions as it pertains to a matter of fact, as Conyers was not present at the
meeting during which the resolutions were adopted (e.g., to verify quorum). This assumption has been consistently used in Conyers’
prior IPO transactions. However, on an exceptional basis, Conyers has revised the section 2.4 of the Exhibit 5.1 of the Amendment No.8.

5. Similarly,
                                            with respect to Assumption 2.9, it is permissible to assume that the company has sufficient
                                            authorized but unissued Ordinary Shares at the time of issuance if you have provided a definitive
                                            opinion that it had sufficient authorized but unissued Ordinary Shares as of the date of
                                            the opinion. Please revise Assumption 2.9 accordingly.

Response:  In response to the Staff’s comments,
Conyers clarified that Assumption 2.9 is a standard assumption included in their opinions as it pertains to a matter of fact, as the
exact number of shares to be issued under the IPO and pursuant to the overallotment options will not be determined at the time the 5.1
opinion is issued. However, on an exceptional basis, Conyers has revised the section 2.9 of the Exhibit 5.1 of the Amendment No.8.

6. Please
                                            revise the legal opinion to quantify the maximum number of shares Conyers Dill & Pearman
                                            have determined can be validly issued. Further, we note that Conyers Dill & Pearman,
                                            in giving consent to the filing of this opinion and states that they “do not hereby
                                            admit that are we are within the category of persons whose consent is required under Section
                                            7 if the Securities Act[.]” It is inappropriate for counsel providing a legal opinion
                                            to deny that it is an expert within the meaning of Sections 7. Please amend accordingly.
                                            See CF Staff Legal Bulletin No. 19.

Response:
In response to the Staff’s comments, the Conyers has revised the Exhibit 5.1 of the Amendment No.8 and deleted the last sentence
in the 5.1 opinion.

    2

If
the Staff has any questions or comments concerning the foregoing, or requires any further information, please contact Ross D. Carmel,
Esq. at (212) 930-9700 ext. 645 or by email at rcarmel@srfc.law. Alternatively, please contact Shane Wu, Esq. at (202) 322-8852 or by
email at swu@srfc.law.

    Very truly yours,

    Sichenzia Ross Ference Carmel
    LLP

    /s/
    Ross D. Carmel, Esq.

    Ross D. Carmel, Esq.

 cc: Shane
Wu, Esq.

1185
AVENUE OF THE AMERICAS | 31ST FLOOR | NEW YORK, NY | 10036

T (212) 930-9700 | F (212) 930-9725 | WWW.SRFC.LAW

3

December 5, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 7 to Registration Statement on Form F-1
Filed November 21, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our November 15, 2024
letter.
Amendment No. 7 to Registration Statement on Form F-1
Our Drug Candidates
MCS-2
Phase III Clinical Studies, page 127
1.We note your response to prior comment 5 on page 27 regarding the "possibly
related" but not "definitely related" pancreatitis event observed in the MCS-2-US-c
trial. Please also include this disclosure in this section, where applicable.

December 5, 2024
Page 2
Legal Proceedings and Compliance
Taizhou Investment Dispute, page 145
2.In response to prior comment 6 you state that under PRC civil procedure, the parties at
any time before and during the enforcement procedure and until such enforcement
procedure it completed, may choose to enter into a settlement agreement. Please
clarify if during the enforcement procedure the company is required to make
payments towards the judgement. If so, please also state the amounts expected to be
paid and whether there is a payment plan or similar agreement in place.
Legal Matters, page 203
3.You state that "[c]ertain legal matters limited to the regulatory history of MCS-
2 before the U.S. Food and Drug Administration (FDA) will be passed upon for us by
Olsson Frank Weeda Terman Matz PC." Please clarify if "regulatory history"
represents a specific date range or all the MCS-2 regulatory process to date. If there is
a date range, please include the range. Further, please file a consent from Olsson
Frank Weeda Terman Matz PC or otherwise state why you do not believe a consent is
required. Please see Rule 436 of the Securities Act of 1933. Similarly identify the
legal matters as to Taiwan law that will be passed upon by KPMG Law Firm and
provide its consent or explain why you believe a consent is not required.
Exhibit 5.1 Legal Opinion, page II-3
4.Please note it is inappropriate to include assumptions in your legal opinion that are
overly broad or assume any material facts underlying the issue or any readily
ascertainable facts. While it is permissible to assume that resolutions that were passed
will remain in full force and will not be rescinded or amended, it is not appropriate to
assume that Resolutions were passed at duly convened, constituted and quorate
meetings or by unanimous resolutions as such assumption is an ascertainable fact and
is material to the underlying issue. Please revise Assumption 2.4 accordingly.
5.Similarly, with respect to Assumption 2.9, it is permissible to assume that the
company has sufficient authorized but unissued Ordinary Shares at the time of
issuance if you have provided a definitive opinion that it had sufficient authorized but
unissued Ordinary Shares as of the date of the opinion. Please revise Assumption 2.9
accordingly.
6.Please revise the legal opinion to quantify the maximum number of shares Conyers
Dill & Pearman have determined can be validly issued. Further, we note that Conyers
Dill & Pearman, in giving consent to the filing of this opinion and states that they "do
not hereby admit that are we are within the category of persons whose consent is
required under Section 7 if the Securities Act[.]" It is inappropriate for counsel
providing a legal opinion to deny that it is an expert within the meaning of Sections 7.
Please amend accordingly. See CF Staff Legal Bulletin No. 19.
            Please contact Mary Mast at 202-551-3613 if you have questions regarding comments
on the financial statements and related matters. Please contact Doris Stacey Gama at 202-
551-3188 or Suzanne Hayes at 202-551-3675 with any other questions.

December 5, 2024
Page 3
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ross Carmel, Esq.

CORRESP
1
filename1.htm

November 21, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

Mary Mast

Doris Stacey Gama

Joe McCann

    Re:

    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Registration Statement on Form F-1/A

    Filed on November 1, 2024 (File No. 333-277725)

Dear Sir and Madam:

On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated November 15, 2024 on the Company’s registration statement on Form F-1/A
filed on November 1, 2024 (the “Registration Statement”). Concurrently with the submission of this letter, the
Company is filing amendment No.7 to Registration Statement (the “Amendment No.7”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.7 where
the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth
in the Amendment No.7.

Prospectus Summary

Overview, page 1

1. We note your response to prior comment 1. Please also update the language throughout
the filings where you cross reference your risk factor on page 31. As an example only, we note the references on pages 5, 7, 30, 112,
115, 124, 126, 128, 133, and 137.

Response: In response to the
Staff’s comments, the Company has revised the disclosure on page 5, 7, 30, 112, 115, 124, 126, 128, 129, 133, and 137 of the Amendment
No.7.

2. In response to prior comment 2 you state that based on prior conversations with
the TFDA you anticipate that the TFDA will accord due consideration to the comments provided by the US FDA. We also note your disclosure
that you have not had discussion with the TFDA regarding the unavailability of API-1. Therefore, please include a brief discussion of
the prior conversations you have had with the TFDA that led you to such conclusion.

Response: In response to the
Staff’s comments, the Company has revised the disclosure on page 2, 6, 115 and 137 of the Amendment No.7.

Use of Proceeds, page 79

3. We note that in response to prior comment 8 you removed disclosure indicating your
plans to use $2.9 million of the proceeds for the settlement of the litigation with Taizhou Bay New District Administrative Committee
and commitments with Taizhou Resource Bureau and state that “at this time” Taizhou Resource Bureau has not claimed for the land
idling fee. We also continue to note that as of June 30, 2024 you had a net working capital deficit of approximately $11.7 million, which
included current liabilities of approximately $5 million and $3.1 million due to Taizhou Bay New District Administrative Committee and
commitments with Taizhou Resources Bureau. Therefore, we reissue the comment. Please clarify the source(s) of funds you intend to use
to settle the amounts owed. Please see Instruction 3 to Item 504 of Regulation S-K.

Response: In response to the
Staff’s comments, the Company has revised the disclosure on page 7 of the Amendment No.7.

Research and Development Expenses,
page 92

4. In response to comment 9 you state that you have completed CMC documentation and
submitted it to the FDA on October 16, 2024. You also state here and on pages 95, 96, 120, and 128, that you received a denial notice
from the FDA stating that the FDA is unable to reach agreement on protocols designed to establish safety and efficacy until you can provide
complete CMC information of API-2 and a plan to establish comparability between API-1 and API-2. Please clarify whether you have also
submitted a plan to establish comparability between API-1 and API-2.

Response: In response to the
Staff’s comments, the Company has revised the disclosure on page 2, 4, 6, 31, 60, 92, 94, 96, 115, 120, 124, 128 and 137 of the
Amendment No.7.

Our Drug Candidate MCS-2, page
120

5. We note your response to prior comment 6 and reissue. Please include a discussion
of the serious adverse event(s) reported that you were not able to conclude were unrelated to your product candidate(s). In this regard
we note that in response to our comment letter issued August 30, 2024, you included tables identifying serious adverse events for your
clinical trials for MCS-2-US and MCS-2-TWN and concluded that “all of SAEs described above were ‘not-related’ to MCS-2, except the
pancreatitis event in the MCS-2-US-c, where the pancreatitis occurred for only 3 days. The causality is ‘possible related’ but not ‘definitely
related’ because it was most likely a side effect of Metformin used to treat diabetes mellitus.”

Response: In response to the
Staff’s comments, the Company has revised the disclosure on page 27 of the Amendment No.7.

Legal Proceedings and Compliance
Taizhou Investment Dispute, page 145

6. In response to prior comment 11 you state that under PRC’s civil procedure, before
the enforcement of an effective judgement form civil litigation is complete, the parties may choose to enter into a settlement agreement
and apply to the court to perform such agreement in lieu of enforcing the judgement. Please also state if there is a time frame in which
such settlement must be reached before the court enforces its judgement.

Response: In response to the
Staff’s comments, the Company has revised the disclosure on page 38 and 145 of the Amendment No.7.

If the Staff has any questions
or comments concerning the foregoing, or requires any further information, please contact Ross D. Carmel, Esq. at (212) 930-9700 ext.
645 or by email at rcarmel@srfc.law. Alternatively, please contact Shane Wu, Esq. at (202) 322-8852 or by email at swu@srfc.law.

    Very truly yours,

    Sichenzia Ross Ference Carmel LLP

    /s/ Ross D. Carmel, Esq.

    Ross D. Carmel, Esq.

 cc: Shane
Wu, Esq.

1185 AVENUE OF THE AMERICAS | 31ST FLOOR | NEW
YORK, NY | 10036

T (212) 930-9700 | F (212) 930-9725 | WWW.SRFC.LAW

November 15, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 6 to Registration Statement on Form F-1
Filed November 1, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our October 24, 2024 letter.
Amendment No. 6 to Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.We note your response to prior comment 1. Please also update the language
throughout the filings where you cross reference your risk factor on page 31. As an
example only, we note the references on pages 5, 7, 30, 112, 115, 124, 126, 128, 133,
and 137.
In response to prior comment 2 you state that based on prior conversations with the
TFDA you anticipate that the TFDA will accord due consideration to the comments
provided by the US FDA. We also note your disclosure that you have not had
discussion with the TFDA regarding the unavailability of API-1. Therefore, please 2.

November 15, 2024
Page 2
include a brief discussion of the prior conversations you have had with the TFDA that
led you to such conclusion.
Use of Proceeds, page 79
3.We note that in response to prior comment 8 you removed disclosure indicating your
plans to use $2.9 million of the proceeds for the settlement of the litigation with
Taizhou Bay New District Administrative Committee and commitments with Taizhou
Resource Bureau and state that "at this time" Taizhou Resource Bureau has not
claimed for the land idling fee. We also continue to note that as of June 30, 2024 you
had a net working capital deficit of approximately $11.7 million, which included
current liabilities of approximately $5 million and $3.1 million due to Taizhou Bay
New District Administrative Committee and commitments with Taizhou Resources
Bureau. Therefore, we reissue the comment. Please clarify the source(s) of funds you
intend to use to settle the amounts owed. Please see Instruction 3 to Item 504 of
Regulation S-K.
Research and Development Expenses, page 92
4.In response to comment 9 you state that you have completed CMC documentation and
submitted it to the FDA on October 16, 2024. You also state here and on pages 95, 96,
120, and 128, that you received a denial notice from the FDA stating that the FDA is
unable to reach agreement on protocols designed to establish safety and efficacy until
you can provide complete CMC information of API-2 and a plan to establish
comparability between API-1 and API-2. Please clarify whether you have also
submitted a plan to establish comparability between API-1 and API-2.
Our Drug Candidate
MCS-2, page 120
5.We note your response to prior comment 6 and reissue. Please include a discussion of
the serious adverse event(s) reported that you were not able to conclude were
unrelated to your product candidate(s). In this regard we note that in response to our
comment letter issued August 30, 2024, you included tables identifying serious
adverse events for your clinical trials for MCS-2-US and MCS-2-TWN and concluded
that "all of SAEs described above were 'not-related' to MCS-2, except the pancreatitis
event in the MCS-2-US-c, where the pancreatitis occurred for only 3 days. The
causality is 'possible related' but not 'definitely related' because it was most likely a
side effect of Metformin used to treat diabetes mellitus."
Legal Proceedings and Compliance
Taizhou Investment Dispute, page 145
6.In response to prior comment 11 you state that under PRC's civil procedure, before the
enforcement of an effective judgement form civil litigation is complete, the parties
may choose to enter into a settlement agreement and apply to the court to perform
such agreement in lieu of enforcing the judgement. Please also state if there is a time
frame in which such settlement must be reached before the court enforces its
judgement.

November 15, 2024
Page 3
            Please contact Mary Mast at 202-551-3613 if you have questions regarding comments
on the financial statements and related matters. Please contact Doris Stacey Gama at 202-
551-3188 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ross Carmel, Esq.

CORRESP
1
filename1.htm

October 31, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

Mary Mast

Doris Stacey Gama

Joe McCann

    Re:

    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Registration Statement on Form F-1/A

    Filed on October 5, 2024 (File No. 333-277725)

Dear Sir and Madam:

On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated October 24, 2024 on the Company’s registration statement on Form F-1/A
filed on October 5, 2024 (the “Registration Statement”). Concurrently with the submission of this letter, the
Company is filing amendment No.6 to Registration Statement (the “Amendment No.6”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.4 where
the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth
in the Amendment No.5.

Prospectus Summary

Summary, page 1

1. We note that in response to prior comments 2, 7, 9 and 10 you state that if you are unable to establish
comparability between API-1 and API-2 you “might” be required to repeat the MCS-2 and PCP clinical trials using API-2. Please
clarify if there is another alternative to move forward with MCS-2 and PCP development other than demonstrating comparability of API-1
and API-2 or repeating the MCS-2 and PCP clinical trials using API-2. If you are referring to no longer pursuing product development please
state so. Please make these revisions throughout your registration statement.

Response: In response to the Staff’s comments,
the Company has revised the disclosure throughout the Amendment No.6.

2. We note your response to prior comment 3 stating that PCP using API-1 is in the source data verification
process, that you are working with the FDA to establish comparability of API-1 and API-2, and that you will discuss the statistical results
of PCP using API-2 with Taiwan regulators and proceed to Phase III if the FDA accepts such results and determines that API-1 and API-2
are comparable. Please clarify, if true, that to date you have not had any discussions with the TFDA regarding the unavailability of API-1
and plan to have such discussions once, and if, you are able to prove comparability of API-1 and API-2. Additionally, clarify the basis
for your belief that the TFDA will accept the U.S. FDA conclusion regarding comparability.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 2, 6, 115 and 137 of the Amendment No.6.

3. We note your responses to prior comment 5 and 12 and reissue those comments. You continue to state that
the “source for API-1 may again become available in the future and, if so, [you] may seek to use it as the source for further drug
development. We note that on page 113, in the context of discussing your NDA for MCS-2 you indicate that if API-1 becomes available again
the supplier’s withdrawal of its consent to reference the DMF “does not mean [you] would not be able to use API-1 in later studies
or as a basis for additional filings with the U.S. FDA.” To the extent you intend to develop MCS-2 using API-1 if it becomes available
again, please clarify that you will have to demonstrate comparability between API-1 prior to the relocation and subsequent to the relocation,
or API-2 and API-1 subsequent to the relocation or perform additional clinical trials or otherwise advise. Please clarify that API-1 subsequent
to the relocation would not be able to rely on clinical trials performed using API-1 available prior to the relocation without a further
comparability determination.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 5 and page 114 of the Amendment No.6. References to the future use of API-1 have been removed.

4. You state on page 4 and 112 that PCP is under Phase II trials stage in Taiwan. Please explain the consequences
if you are unable to identify an active pharmaceutical ingredient that the FDA agrees is comparable to API-1.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 4 and Page 112 of the Amendment No.6. Additionally, we incorporated language on page 31
addressing the consequences should the Company be unable to identify an active pharmaceutical ingredient that the FDA deems comparable
to API-1, in which case Phase I and Phase II of the PCP trials would be required to be repeated using API-1.

Risk Factors Summary, page 13

5. Please include a bullet point indicating that if you are unable to identify a supplier capable of producing
API-2 that is sufficiently comparable to API-1, you will be required to repeat your clinical trials for MCS-2 and PCP, which will delay
your product development efforts and result in increased costs.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 14 of the Amendment No.6.

Risk Factors

Our drug candidate ,..., page 27

6. We note your response to prior comment 8. Please also identify the serious adverse event(s) reported that
you were not able to conclude were unrelated to your product candidate(s).

Response: In the clinical trials, the identification
and assessment of serious adverse events (SAEs) are conducted based on the professional judgment and clinical data provided by clinical
physicians under double-blind conditions. To date, no MCS-related SAEs have occurred in the pivotal studies.

    2

Use of Proceeds, page 79

7. We note your use of proceeds discussion indicates your intent to use proceeds from the offering to fund
the additional Phase III trials of MCS-2 (API-2). Please revise your disclosure to quantify proceeds that you will spend on earlier phase
trials if you are unable to demonstrate comparability.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 79 of the Amendment No.6.

8. We note that as of June 30, 2024 you had a net working capital deficit of approximately $11.7 million,
which included current liabilities of approximately $5 million and $3.1 million due to Taizhou Bay New District Administrative Committee
and commitments with Taizhou Resources Bureau. Additionally, we note your plans to spend $2.9 million of the proceeds for the settlement
of this litigation. Please clarify the source(s) of other funds you intend to use to pay these amounts owed. Please see Instruction 3
to Item 504 of Regulation S-K.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 7 and 79 of the Amendment No.6.

Research and Development Expenses,
page 95

9. You state that you have asked the US FDA to provide a written response to questions focused on obtaining
US FDA review and comments on a new, proposed Phase III clinical trial protocol for MCS-2 with API-2 and a pharmacokinetic study. Please
also include disclosure stating that on May 23, 2024 you received a denial notice from the FDA stating that until the company can provide
complete Chemistry, Manufacturing, and Controls (CMC) information on the active pharmaceutical ingredient-2 (API-2) and a plan to establish
comparability between API-1 and API-2, the U.S. FDA is unable to reach agreement on protocols designed to establish the safety and efficacy
of MCS-2, as you do on page 3.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 92, 94, 96 and 120 of the Amendment No.6.

Phase III Clinical Trials, page
127

10. We note your response to prior comment 11. We also note that you your disclosure stating that the FDA’s
concerns regarding reproducibility of some of the reported efficacy results for MCS-2-TWN-a can be resolved after you propose to re-analyze
the MCS-2-TWN-a study data using CDISC data set that is matched with the U.S. FDA requested format remains. Therefore, we reissue the
comment. This disclosure appears to assume the FDA will be satisfied with the results when you re-analyze the data. While indicating that
you plan to re-analyze the data using the CDISC data sets matched with the FDA requested data format seems reasonable, your assumption
that this will resolve the issue to the satisfaction of the FDA is speculative and not appropriate. Please revise your disclosure to remove
the indication that this may resolve the FDA’s concerns.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 129 of the Amendment No.6. We have removed the sentence, “This can be resolved after
we propose to re-analyze the MCS-2-TWN-a study data using CDISC data sets that match the U.S. FDA’s requested data format.”

Legal Proceedings and Compliance
Taizhou Investment Dispute, page 145

11. In response to comment 13 you state that the on August 9, 2024 the High People’s Court of Zhejiang
Province scheduled a hearing for your Taizhou appeal and later issued a judgement against you to sustain the ruling of the Taizhou Court.
Based on this result, please clearly state the total amounts you are required to pay the Plaintiff. Further, you also state that you are
actively negotiating with the Plaintiff for a settlement of this legal proceeding. Please clarify how you are still pursuing a settlement
after a final judgement has been reached.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 37 and 145 of the Amendment No.6.

    3

If the Staff has any questions
or comments concerning the foregoing, or requires any further information, please contact Ross D. Carmel, Esq. at (212) 930-9700 ext.
645 or by email at rcarmel@srfc.law. Alternatively, please contact Shane Wu, Esq. at (202) 322-8852 or by email at swu@srfc.law.

    Very truly yours,

    Sichenzia Ross Ference Carmel LLP

    /s/ Ross D. Carmel, Esq.

    Ross D. Carmel, Esq.

    cc:
    Shane Wu, Esq.

1185 AVENUE OF THE AMERICAS | 31ST FLOOR | NEW
YORK, NY | 10036

T (212) 930-9700 | F (212) 930-9725 | WWW.SRFC.LAW

    4

October 24, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 5 to Registration Statement on Form F-1
Filed October 5, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our August 30, 2024 letter.
Amendment No. 5 to Registration Statement on Form F-1
Prospectus Summary
Summary, page 1
1.We note that in response to prior comments 2, 7, 9 and 10 you state that if you are
unable to establish comparability between API-1 and API-2 you "might" be required
to repeat the MCS-2 and PCP clinical trials using API-2. Please clarify if there is
another alternative to move forward with MCS-2 and PCP development other than
demonstrating comparability of API-1 and API-2 or repeating the MCS-2 and PCP
clinical trials using API-2. If you are referring to no longer pursuing product
development please state so. Please make these revisions throughout your registration
statement.

October 24, 2024
Page 2
2.We note your response to prior comment 3 stating that PCP using API-1 is in the
source data verification process, that you are working with the FDA to establish
comparability of API-1 and API-2, and that you will discuss the statistical results of
PCP using API-2 with Taiwan regulators and proceed to Phase III if the FDA accepts
such results and determines that API-1 and API-2 are comparable. Please clarify, if
true, that to date you have not had any discussions with the TFDA regarding the
unavailability of API-1 and plan to have such discussions once, and if, you are able to
prove comparability of API-1 and API-2. Additionally, clarify the basis for your belief
that the TFDA will accept the U.S. FDA conclusion regarding comparability.
3.We note your responses to prior comment 5 and 12 and reissue those comments. You
continue to state that the "source for API-1 may again become available in the future
and, if so, [you] may seek to use it as the source for further drug development. We
note that on page 113, in the context of discussing your NDA for MCS-2 you indicate
that if API-1 becomes available again the supplier's withdrawal of its consent to
reference the DMF "does not mean [you] would not be able to use API-1 in later
studies or as a basis for additional filings with the U.S. FDA." To the extent you
intend to develop MCS-2 using API-1 if it becomes available again, please clarify that
you will have to demonstrate comparability between API-1 prior to the relocation and
subsequent to the relocation, or API-2 and API-1 subsequent to the relocation or
perform additional clinical trials or otherwise advise. Please clarify that API-1
subsequent to the relocation would not be able to rely on clinical trials performed
using API-1 available prior to the relocation without a further comparability
determination.
4.You state on page 4 and 112 that PCP is under Phase II trials stage in Taiwan. Please
explain the consequences if you are unable to identify an active pharmaceutical
ingredient that the FDA agrees is comparable to API-1.
Risk Factors Summary, page 13
5.Please include a bullet point indicating that if you are unable to identify a supplier
capable of producing API-2 that is sufficiently comparable to API-1, you will be
required to repeat your clinical trials for MCS-2 and PCP, which will delay your
product development efforts and result in increased costs.
Risk Factors
Our drug candidate may cause serious adverse,..., page 27
6.We note your response to prior comment 8. Please also identify the serious adverse
event(s) reported that you were not able to conclude were unrelated to your product
candidate(s).
Use of Proceeds, page 79
7.We note your use of proceeds discussion indicates your intent to use proceeds from
the offering to fund the additional Phase III trials of MCS-2 (API-2). Please revise
your disclosure to quantify proceeds that you will spend on earlier phase trials if you
are unable to demonstrate comparability.

October 24, 2024
Page 3
8.We note that as of June 30, 2024 you had a net working capital deficit of
approximately $11.7 million, which included current liabilities of approximately
$5 million and $3.1 million due to Taizhou Bay New District Administrative
Committee and commitments with Taizhou Resources Bureau. Additionally, we note
your plans to spend $2.9 million of the proceeds for the settlement of this litigation.
Please clarify the source(s) of other funds you intend to use to pay these amounts
owed. Please see Instruction 3 to Item 504 of Regulation S-K.
Research and Development Expenses, page 95
9.You state that you have asked the US FDA to provide a written response to questions
focused on obtaining US FDA review and comments on a new, proposed Phase III
clinical trial protocol for MCS-2 with API-2 and a pharmacokinetic study. Please also
include disclosure stating that on May 23, 2024 you received a denial notice from the
FDA stating that until the company can provide complete Chemistry, Manufacturing,
and Controls (CMC) information on the active pharmaceutical ingredient-2 (API-2)
and a plan to establish comparability between API-1 and API-2, the U.S. FDA is
unable to reach agreement on protocols designed to establish the safety and efficacy
of MCS-2, as you do on page 3.
Phase III Clinical Trials, page 127
10.We note your response to prior comment 11. We also note that you your disclosure
stating that the FDA's concerns regarding reproducibility of some of the reported
efficacy results for MCS-2-TWN-a can be resolved after you propose to re-analyze
the MCS-2-TWN-a study data using CDISC data set that is matched with the U.S.
FDA requested format remains. Therefore, we reissue the comment. This disclosure
appears to assume the FDA will be satisfied with the results when you re-analyze the
data. While indicating that you plan to re-analyze the data using the CDISC data sets
matched with the FDA requested data format seems reasonable, your assumption that
this will resolve the issue to the satisfaction of the FDA is speculative and not
appropriate. Please revise your disclosure to remove the indication that this may
resolve the FDA's concerns.
Legal Proceedings and Compliance
Taizhou Investment Dispute, page 145
11.In response to comment 13 you state that the on August 9, 2024 the High People’s
Court of Zhejiang Province scheduled a hearing for your Taizhou appeal and later
issued a judgement against you to sustain the ruling of the Taizhou Court. Based on
this result, please clearly state the total amounts you are required to pay the Plaintiff.
Further, you also state that you are actively negotiating with the Plaintiff for a
settlement of this legal proceeding. Please clarify how you are still pursuing a
settlement after a final judgement has been reached.
            Please contact Mary Mast at 202-551-3613 if you have questions regarding comments
on the financial statements and related matters. Please contact Doris Stacey Gama at 202-
551-3188 or Suzanne Hayes at 202-551-3675 with any other questions.

October 24, 2024
Page 4
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ross Carmel, Esq.

CORRESP
1
filename1.htm

October 4, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

    Mary Mast

    Doris Stacey Gama

    Joe McCann

    Re:

    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Registration Statement on Form F-1/A

    Filed on September 16, 2024 (File No. 333-277725)

Dear Sir and Madam:

On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated September 26, 2024 on the Company’s registration statement on Form F-1/A
filed on September 16, 2024 (the “Registration Statement”). Concurrently with the submission of this letter, the
Company is filing amendment No.5 to Registration Statement (the “Amendment No.5”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.4 where
the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth
in the Amendment No.4.

Overview, page 1

1. We note the disclosure on page 4 above your pipeline table
stating that the following chart illustrates and summarizes your drug candidates if you are unable to establish the comparability between
API-1 and API-2. Please include additional disclosure to highlight that you have not yet proven comparability between API-1 and API-2
and therefore the table summarizes your current status.

Response: In response to the Staff’s comments, the
Company has revised the disclosure on page 4 and page 112 of the Amendment No.5.

2. We continue to object to your presentation of two pipeline
tables on pages 4 and 112. The pipeline table should depict your material product candidates in their current state of development, as
depicted in the first pipeline table. The pipeline table should not assume that the FDA might allow any exceptions to its regular developmental
process that have not been approved or that you have successfully completed tests/trials to the FDA’s satisfaction that have not yet
been performed or remain ongoing. These events are aspirational, and do not reflect the current status of your product candidates. Including
multiple tables does not addresses our concerns about your presentation. Please remove the second table on pages 4 and 112 that illustrates
the status of your drug products if you were to establish comparability between API-1 and API-2.

Response: In response to the Staff’s comments, the
Company has revised the disclosure on page 4 and page 112 of the Amendment No.5.

If the Staff has any questions
or comments concerning the foregoing, or requires any further information, please contact Ross D. Carmel, Esq. at (212) 930-9700 ext.
645 or by email at rcarmel@srfc.law. Alternatively, please contact Shane Wu, Esq. at (202) 322-8852 or by email at swu@srfc.law.

    Very truly yours,

    Sichenzia Ross Ference Carmel LLP

    /s/ Ross D. Carmel, Esq.

    Ross D. Carmel, Esq.

    cc:
    Shane Wu, Esq.

1185 AVENUE OF THE AMERICAS | 31ST FLOOR | NEW
YORK, NY | 10036

T (212) 930-9700 | F (212) 930-9725 | WWW.SRFC.LAW

September 26, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 4 to Registration Statement on Form F-1
Filed September 16, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have limited our review of your amended registration statement to your response to
comment 4 from our August 30, 2024 letter and associated revisions to your registration
statement. We have the following comments. Once we have resolved the issues raised in these
comments, we will review the remaining responses. After reviewing any amendment to your
registration statement and the information you provide in response to this letter, we may have
additional comments.
Amendment No. 4 to Draft Registration Statement on Form F-1
Overview, page 1
1.We note the disclosure on page 4 above your pipeline table stating that the following chart
illustrates and summarizes your drug candidates if you are unable to establish the
comparability between API-1 and API-2. Please include additional disclosure to highlight
that you have not yet proven comparability between API-1 and API-2 and therefore the
table summarizes your current status.
We continue to object to your presentation of two pipeline tables on pages 4 and 112.
The pipeline table should depict your material product candidates in their current state of
development, as depicted in the first pipeline table. The pipeline table should not assume
that the FDA might allow any exceptions to its regular developmental process that have
not been approved or that you have successfully completed tests/trials to the FDA's
satisfaction that have not yet been performed or remain ongoing. These events are
aspirational, and do not reflect the current status of your product candidates. Including
multiple tables does not addresses our concerns about your presentation. Please remove
the second table on pages 4 and 112 that illustrates the status of your drug products if you 2.

September 26, 2024
Page 2
were to establish comparability between API-1 and API-2.
            Please contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 if you have
questions regarding comments on the financial statements and related matters. Please contact
Doris Stacey Gama at 202-551-3188 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ross Carmel, Esq.

CORRESP
1
filename1.htm

September 13, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

Mary Mast

Doris Stacey Gama

Joe McCann

    Re:

    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Registration Statement on Form F-1/A

    Filed on August 2, 2024 (File No. 333-277725)

Dear Sir and Madam:

On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated August 30, 2024 on the Company’s registration statement on Form F-1/A
filed on August 2, 2024 (the “Registration Statement”). Concurrently with the submission of this letter, the Company
is filing amendment No.4 to Registration Statement (the “Amendment No.4”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.4 where
the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth
in the Amendment No.4.

Overview, page 1

 1. We note your response to prior comment 1. Please expand the discussion of the FDA concerns to also identify the concerns of an NDA
supported by a single positive trial for the treatment of symptomatic conditions, such as BPH, and the potential effect of bias, including
investigational site bias or chance. Given that you have not yet submitted a comparability plan, it is not appropriate to assume you will
successfully demonstrate the comparability of API-1 and API-2. Similarly revise your discussion on pages 30 and 120. You may indicate
that you plan to submit a comparability plan and that if you are successful you plan to rely on trials that were previously conducted
using API-1. However, you should indicate that of the two pivotal trials, one failed to show a treatment difference between the primary
efficacy endpoint and the FDA had concerns regarding the reproducibility of some of the reported efficacy results of the other.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 1, 32 and 123 of the Amendment No.4.

 2. We note your response to prior comment 2 and reissue. Although you are confident in the comparability between API-1 and API-2 you
have not completed such comparability studies and as such there is an inherent risk that you may not be able to prove comparability. Therefore,
please revise your disclosure throughout your filing to remove language indicating that the comparability is an inevitable conclusion,
such as “[O]nce the US FDA is convinced about the comparability of API-1 and API-2…” We also note you include language
discussing next steps if you are able to demonstrate comparably and language discussing looking for an alternative vendor to prove comparability.
Please also discuss your path forward if you are not able to find another supplier and achieve comparability at all for both MCS-2 and
PCP.

Further, we note your response indicating that the botanical
substance is under the same patent owned by the company, and you fully understand the harvesting, raw material preparation and processing
operations. However, it is clear that the FDA has a rigorous process for determining comparability. The fact that you are using a botanical
substance produced under the same patent and understand the operations does not guarantee that your comparability studies will be successful.
Please clearly state that your intention to identify another potential supplier and repeat the process of demonstrating comparability
between API-1 and API-2 is to avoid having to repeat all of your clinical trials. If you are unable to identify supplier that is able
to produce API-2 that is sufficiently comparable to API-1, you will have to repeat the trials you conducted using API-1.

Response: In response to the Staff’s comments,
we modified the language”[O]nce the US FDA is convinced of the comparability of API-1 and API-2...” throughout the filing. Additionally,
we have added a risk factor on page 32, explaining that if we are unable to identify a supplier capable of producing API-2 that is sufficiently
comparable to API-1, we may be required to repeat our clinical trials for MCS-2 and PCP.

 3. We note your response to prior comment 2 regarding your product candidate PCP. Specifically, that you have not spoken to the Taiwan
regulator regarding the unavailability of API-1 and that you plan to initiate discussions only if, and after you have achieved comparability
of API-1 and API-2 and have begun PK and Phase III studies for MCS-2 (API-2). As such, please clarify that PCP is currently at a standstill
in Taiwan and, if true, that PCP will not be moving forward in Taiwan until you have demonstrated comparability to the FDA. Please discuss
the consequences if you are unable to identify a supplier of API-2 that the FDA agrees is sufficiently comparable to API-1 and include
a risk factor discussing this risk and potential consequences.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 2, 7, 115 and 136 of the Amendment No.4. Additionally, we have added a risk factor on page
32, explaining that if we are unable to identify a supplier capable of producing API-2 that is sufficiently comparable to API-1, we may
be required to repeat our clinical trials for MCS-2 and PCP.

 4. We note your response to prior comment 5 and corresponding revisions. However, despite your response that these tables are important
to your plans, we continue to object to your presentation. The pipeline table should depict your material product candidates in their
current state of development. One line should be included for each product candidate being developed to address a single indication in
each jurisdiction. The current state of development is an indication as to what steps have been completed, and does not assume that the
FDA allows any exceptions to its regular developmental process, that it has not yet indicated it is willing to grant, or approved tests
or studies that you have not yet performed to its satisfaction. Including multiple tables does not result in disclosure that addresses
our concerns about your presentation. Please make the following changes to your table:

 ● Revise your pipeline tables to present one pipeline table that presents each of your material product candidates being developed to
address a single indication in each jurisdiction once.

 ● Present MCS-2 (API-2) in its current state of development, which means that the FDA has not made a determination as to the comparability
of API-1 and API-2. The current presentation is speculative.

 ● Remove all line items that are dependent on the availability of API-1. API-1 is currently not available. While you have discussed
the possibility of it becoming available again at some point in the future, the availability of it becoming available again and its comparability
following the supplier’s relocation are speculative.

    2

We do not object to your disclosure of your plans to submit
CMC information in hopes of establishing comparability and your ability to rely on previously conducted trials if you are successful in
establishing comparability.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 4 and 112 of the Amendment No.4.

 5. In response to prior comment 6 you state that you interpret the FDA’s use of the word “source” to be a reference to the
entity responsible for manufacturing an API, not a reference to the physical location of a manufacturing facility. We disagree based on
the plain language of the guidance provided in the FDA’s June 26, 2023 letter, which is consistent with the FDA’s online Botanical Guidance
(https://www.fda.gov/files/drugs/published/Botanical-Drug-Development--Guidance-for- Industry.pdf). Please also note the language you
include in your registration statement on page 50 “API-1 and API-2 are similar drug substances covered by the same patent owned by
us; however, because they are sourced from raw materials manufactured in different locations, the U.S. FDA considers them to be different
botanical substances.” To the extent you intend to develop MCS-2 using API-1 if it becomes available again, please clarify that you
will have to demonstrate comparability between API-1 prior to the relocation and subsequent to the relocation, or API-2 and API-1 subsequent
to the relocation or perform additional clinical trials.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 5 and 113 of the Amendment No.4. The statement regarding the future use of API-1 has been removed.

 6. We note your response to prior comment 7. Please revise your disclosure on page 5 to clarify that the guidance you received from the
FDA was in response to a question you posed to the FDA related to your concerns about a potential shortage of raw material supplies and
that the FDA’s guidance and the FDA’s online Botanical Drug Development Guidance for Industry encouraged the selection of multiple vendors
and implementing Good Agricultural and Collection Practices for all raw material vendors, prior to conducting phase 3 trials. Please note
that substituting a new raw material after some clinical trials had been completed was not discussed.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 5 and 113 of the Amendment No.4. The statement regarding the “U.S. FDA encouraged us to select multiple vendors for the botanical raw material” has been removed.

 7. In response to prior comment 10 you state that if API-1 and API-2 is not comparable one option would be to work with another API vendor
to demonstrate comparability. Please also discuss here and wherever else applicable, that if you are unable to demonstrate comparability
you will have to re-perform PCP clinical trials again using PCP (API-2).

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 4, 32 and 137 of the Amendment No.4. Additionally, we have added a risk factor on page
32, explaining that if we are unable to identify a supplier capable of producing API-2 that is sufficiently comparable to API-1, we may
be required to repeat our clinical trials for MCS-2 and PCP.

    3

Risk Factors

Our drug candidates may cause serious adverse, undesirable
side effects..., page 27

 8. Please identify the serious adverse events reported in the clinical trials of each of your drug candidates.

Response:

MCS-2-US-a:

    Phase III Clinical Trials

    MCS-2 (API-1)
 15 mg/day
    MCS-2 (API-1)
 30 mg/day
    Placebo
    Total

    N=42
 N (%)
    N=156
 N (%)
    N=76
 N (%)
    N=274
 N (%)

    Serious Adverse Event (SAE)
    0 (0.0)
    1 (0.6)
    2 (2.6)
    3 (1.1)

    -

Myocardial

    -
    Ataxia

    infarction
    -
    Depression

MCS-2-US-c:

    Phase III Clinical Trials (Long-term)

    MCS-2 (API-1)
 15-30 mg/day

    MCS-2 (API-1)
 30 mg to
 30 mg/day

    MCS-2 (API-1)
 0-30 mg/day

    Total

    N=28
 N (%)

    N=102
 N (%)

    N=51
 N (%)

    N=181
 N (%)

    Serious Adverse Event (SAE)

    0 (0)

    6 (5.9)

    3 (5.9)

    9 (5.0)

  -
  Angina pectoris

  -
  Gastritis

  -
  Pancreatitis

  haemorrhagic

  -
  Back pain

  -
  Tongue neoplasm

  -
  Osteonecrosis

  malignant

  -
  Oesophageal

  -
  Transient

  adenocarcinoma

  ischaemic attack

MCS-2-TWN-a:

    Phase III Clinical Trials

    MCS-2 (API-1)
 30 mg/day
    Placebo
    Total

    N=182
 N (%)
    N=89
 N (%)
    N=271
 N (%)

    Serious Adverse Event (SAE)
    2 (1.1)
    2 (2.2)
    4 (1.5)

    -
    Pyrexia and Liver function
    -
    Atrial fibrillation

    test abnormal
    -
    Prostatitis

    -
    Transient ischaemic attack

    4

MCS-2-TWN-c:

    Phase III Clinical Trials (Long-term)

    MCS-2 (API-1)

0-30 mg/day

    MCS-2 (API-1)

30 mg to

30 mg/day

    Total

    N=56

N (%)

    N=124

N (%)

    N=180

N (%)

    Serious Adverse Event (SAE)

    2 (3.6)

    5 (4.0)

    7 (3.9)

    -
    Urinary tract infection &

    -
    Bile duct stone &

    Prostatitis

    Gastrointestinal tract

    -
    Calculus ureteric

    adenoma

    -
    Benign

    mesothelioma

    -
    Basal cell carcinoma

    -
    Lumbar vertebral

    fracture &

    Spondylolisthesis

    -
    Thyroid neoplasm

All of SAEs described above were “not-related” to MCS-2,
except the pancreatitis event in the MCS-2-US-c, where the pancreatitis occurred for only 3 days. The causality is “possible related”
but not “definitely related” because it was most likely a side effect of Metformin used to treat diabetes
mellitus.

PCP:

Phase II clinical study of PCP was a double-blind, randomized,
placebo-controlled, parallel one, with a group of 702 subjects for a two-year treatment. This phase II clinical study is still in
process and the P value and conclusions as to the statistical significance are not available. PCP Phase II study is now in the source
data verification (SDV) stage, therefore, we are unable to identify serious adverse events now.

IC:

There are no SAE yet since the IC is still in the phase I stage.

Potential Non-Acceptance by the U.S. FDA of API-1 and
API-2 Comparability..., page 29

 9. In response to prior comment 3 you include a risk factor on page 29 stating that there is a risk that the FDA may determine that API-1
and API-2 are not sufficiently comparable and you would have to perform more clinical trials. Please discuss the additional clinical trials
that you would need to perform if API-1 and API-2 are not found to be comparable.

Response: In response to the Staff’s comments, the Company
has revised the disclosure on page 32 of Amendment No. 4 by adding a risk factor that explains if we are unable to identify a supplier
capable of producing API-2 that is sufficiently comparable to API-1, we may be required to repeat our clinical trials for MCS-2 and PCP.

    5

Our Drug Candidate

Phase II Clinical Studies, page 123

 10. We note your response to prior comment 11 stating that if API-1 and API-2 are not comparable you will work with another API vendor
to demonstrate comparability. Given that you have not yet completed comparability studies between API-1 and API-2 it is speculative to
assume that because you know all the steps and information necessary that you will achieve comparability, as such we reissue the comment.
Please include disclosure under Phase II and Phase III Clinical Studies, on pages 123 and 124 respectively, to state that if your comparability
studies are not accepted by the FDA you will need to conduct additional Phase II and Phase III studies to continue your clinical development.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 126 and 127 of the Amendment No.4.

Phase III Clinical Studies, page 124

 11. In response to prior comment 12 you state that the FDA’s concerns regarding reproducibility of some of the reported efficacy results
for MCS-2-TWN-a can be resolved after you propose to re-analyze the MCS-2-TWN-a study data using CDISC data set that is matched with the
U.S. FDA requested format. This disclosure appears to assume the FDA will be satisfied with the results when you re-analyze the data.
While indicating that you plan to re-analyze the data using the CDISC data sets matched with the FDA requested data format seems reasonable,
your assumption that this will resolve the issue to the satisfaction of the FDA is speculative and not appropriate. Please revise your
disclosure to remove the indication that this will resolve the FDA’s concerns.

Resp

August 30, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 3 to Registration Statement on Form F-1
Filed August 2, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our July 19, 2024 letter.
Amendment No. 3 to Registration Statement on Form F-1
Overview, page 1
We note your response to prior comment 1. Please expand the discussion of the FDA
concerns to also identify the concerns of an NDA supported by a single positive trial for
the treatment of symptomatic conditions, such as BPH, and the potential effect of bias,
including investigational site bias or chance. Given that you have not yet submitted a
comparability plan, it is not appropriate to assume you will successfully demonstrate the
comparability of API-1 and API-2. Similarly revise your discussion on pages 30 and 120.
You may indicate that you plan to submit a comparability plan and that if you are
successful you plan to rely on trials that were previously conducted using API-1.
However, you should indicate that of the two pivotal trials, one failed to show a treatment
difference between the primary efficacy endpoint and the FDA had concerns regarding the 1.

August 30, 2024
Page 2
reproducibility of some of the reported efficacy results of the other.
2.We note your response to prior comment 2 and reissue. Although you are confident in the
comparability between API-1 and API-2 you have not completed such comparability
studies and as such there is an inherent risk that you may not be able to prove
comparability. Therefore, please revise your disclosure throughout your filing to remove
language indicating that the comparability is an inevitable conclusion, such as “[O]nce the
US FDA is convinced about the comparability of API-1 and API-2....” We also note
you include language discussing next steps if you are able to demonstrate comparably and
language discussing looking for an alternative vendor to prove comparability. Please also
discuss your path forward if you are not able to find another supplier and achieve
comparability at all for both MCS-2 and PCP.

Further, we note your response indicating that the botanical substance is under the same
patent owned by the company, and you fully understand the harvesting, raw material
preparation and processing operations. However, it is clear that the FDA has a rigorous
process for determining comparability. The fact that you are using a botanical substance
produced under the same patent and understand the operations does not guarantee that
your comparability studies will be successful. Please clearly state that your intention to
identify another potential supplier and repeat the process of demonstrating comparability
between API-1 and API-2 is to avoid having to repeat all of your clinical trials. If you are
unable to identify supplier that is able to produce API-2 that is sufficiently comparable to
API-1, you will have to repeat the trials you conducted using API-1.
3.We note your response to prior comment 2 regarding your product candidate PCP.
Specifically, that you have not spoken to the Taiwan regulator regarding the unavailability
of API-1 and that you plan to initiate discussions only if, and after you have achieved
comparability of API-1 and API-2 and have begun PK and Phase III studies for MCS-2
(API-2). As such, please clarify that PCP is currently at a standstill in Taiwan and, if true,
that PCP will not be moving forward in Taiwan until you have demonstrated
comparability to the FDA. Please discuss the consequences if you are unable to identify a
supplier of API-2 that the FDA agrees is sufficiently comparable to API-1 and include a
risk factor discussing this risk and potential consequences.
We note your response to prior comment 5 and corresponding revisions. However, despite
your response that these tables are important to your plans, we continue to object to your
presentation. The pipeline table should depict your material product candidates in their
current state of development. One line should be included for each product candidate
being developed to address a single indication in each jurisdiction. The current state of
development is an indication as to what steps have been completed, and does not assume
that the FDA allows any exceptions to its regular developmental process, that it has not
yet indicated it is willing to grant, or approved tests or studies that you have not yet
performed to its satisfaction. Including multiple tables does not result in disclosure that
addresses our concerns about your presentation. Please make the following changes to
your table:

Revise your pipeline tables to present one pipeline table that presents each of your
material product candidates being developed to address a single indication in each •4.

August 30, 2024
Page 3
jurisdiction once.
•Present MCS-2 (API-2) in its current state of development, which means that the
FDA has not made a determination as to the comparability of API-1 and API-2. The
current presentation is speculative.
•Remove all line items that are dependent on the availability of API-1. API-1 is
currently not available. While you have discussed the possibility of it becoming
available again at some point in the future, the availability of it becoming available
again and its comparability following the supplier’s relocation are speculative.

We do not object to your disclosure of your plans to submit CMC information in hopes of
establishing comparability and your ability to rely on previously conducted trials if you
are successful in establishing comparability.
5.In response to prior comment 6 you state that you interpret the FDA's use of the word
"source" to be a reference to the entity responsible for manufacturing an API, not a
reference to the physical location of a manufacturing facility. We disagree based on the
plain language of the guidance provided in the FDA's June 26, 2023 letter, which is
consistent with the FDA's online Botanical Guidance
(https://www.fda.gov/files/drugs/published/Botanical-Drug-Development--Guidance-for-
Industry.pdf). Please also note the language you include in your registration statement on
page 50 "API-1 and API-2 are similar drug substances covered by the same patent owned
by us; however, because they are sourced from raw materials manufactured in different
locations, the U.S. FDA considers them to be different botanical substances." To the
extent you intend to develop MCS-2 using API-1 if it becomes available again, please
clarify that you will have to demonstrate comparability between API-1 prior to the
relocation and subsequent to the relocation, or API-2 and API-1 subsequent to the
relocation or perform additional clinical trials.
6.We note your response to prior comment 7. Please revise your disclosure on page 5 to
clarify that the guidance you received from the FDA was in response to a question you
posed to the FDA related to your concerns about a potential shortage of raw material
supplies and that the FDA's guidance and the FDA's online Botanical Drug Development
Guidance for Industry encouraged the selection of multiple vendors and implementing
Good Agricultural and Collection Practices for all raw material vendors, prior to
conducting phase 3 trials. Please note that substituting a new raw material after some
clinical trials had been completed was not discussed.
7.In response to prior comment 10 you state that if API-1 and API-2 is not comparable one
option would be to work with another API vendor to demonstrate comparability. Please
also discuss here and wherever else applicable, that if you are unable to demonstrate
comparability you will have to re-perform PCP clinical trials again using PCP (API-2).
Risk Factors
Our drug candidates may cause serious adverse, undesirable side efects..., page 27
8.Please identify the serious adverse events reported in the clinical trials of each of your
drug candidates.

August 30, 2024
Page 4
Potential Non-Acceptance by the U.S. FDA of API-1 and API-2 Comparability..., page 29
9.In response to prior comment 3 you include a risk factor on page 29 stating that there is a
risk that the FDA may determine that API-1 and API-2 are not sufficiently comparable
and you would have to perform more clinical trials. Please discuss the additional clinical
trials that you would need to perform if API-1 and API-2 are not found to be comparable.
Our Drug Candidate
Phase II Clinical Studies, page 123
10.We note your response to prior comment 11 stating that if API-1 and API-2 are not
comparable you will work with another API vendor to demonstrate comparability. Given
that you have not yet completed comparability studies between API-1 and API-2 it is
speculative to assume that because you know all the steps and information necessary that
you will achieve comparability, as such we reissue the comment. Please include
disclosure under Phase II and Phase III Clinical Studies, on pages 123 and 124
respectively, to state that if your comparability studies are not accepted by the FDA you
will need to conduct additional Phase II and Phase III studies to continue your clinical
development.
Phase III Clinical Studies, page 124
11.In response to prior comment 12 you state that the FDA's concerns regarding
reproducibility of some of the reported efficacy results for MCS-2-TWN-a can be
resolved after you propose to re-analyze the MCS-2-TWN-a study data using CDISC data
set that is matched with the U.S. FDA requested format. This disclosure appears to
assume the FDA will be satisfied with the results when you re-analyze the data. While
indicating that you plan to re-analyze the data using the CDISC data sets matched with the
FDA requested data format seems reasonable, your assumption that this will resolve the
issue to the satisfaction of the FDA is speculative and not appropriate. Please revise your
disclosure to remove the indication that this will resolve the FDA's concerns.
12.We note your response to prior comment 13, specifically that if you are unable to
demonstrate comparability, you would have to perform more clinical trials. Please clearly
identify the additional clinical trials you are referring to. Also, revise your statement "If
we continue to develop MCS-2 (API-1) in the future, although the Phase III study in the
US (MCS-2-US-a), failed to show a difference between treatment groups for the primary
efficacy endpoint in the intent-to-treat population, we may not need to reproduce the
Phase III study in the US if the U.S. FDA has approved the comparability of API-1 and
API-2 and the results of an additional Phase III study (MCS-2_US-b) using API-2" to add
that it would also be necessary for you to demonstrate that the new API-1 subsequent to
the relocation was determined to be comparable to either the API-1 prior to the relocation
or API-2. Alternatively, delete the statement.
Legal Proceedings and Compliance
Taizhou Investment Dispute, page 141
13.You state that the High People's Court of Zhejiang Province scheduled a hearing for your
Taizhou appeal for August 9, 2024. Please discuss the outcome of such hearing.

August 30, 2024
Page 5
            Please contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 if you have
questions regarding comments on the financial statements and related matters. Please contact
Doris Stacey Gama at 202-551-3188 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ross Carmel, Esq.

CORRESP
1
filename1.htm

August 2, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

    Mary Mast

    Doris Stacey Gama

    Joe McCann

    Re:

    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Registration Statement on Form F-1/A

    Filed on June 21, 2024 (File No. 333-277725)

Dear Sir and Madam:

On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated July 19, 2024 on the Company’s registration statement on Form F-1/A
filed on June 21, 2024 (the “Registration Statement”). Concurrently with the submission of this letter, the Company
is filing amendment No.3 to Registration Statement (the “Amendment No.3”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.3 where
the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth
in the Amendment No.3.

Prospectus Summary

Overview, page 1

1. Please revise the discussion of your current plans to develop MCS-2 (API-2) to clarify the FDA’s
concerns communicated on pages 1-2 of its February 23, 2024 correspondence, which you provided in response to our May 31, 2024 request.
The communication indicates that your proposed plan to conduct one phase 1 study and one phase 3 efficacy study using your product containing
API-2 faces significant challenges. Please update your Summary to briefly describe the FDA’s concerns and provide a more fulsome
discussion of these concerns in the Business section.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 3 and page 120 of the Amendment No.3.

We understand FDA concerns on the failure of our MCS-2-US-a
study using API-1, so we planned to conduct an additional Phase III pivotal study (MCS-2-US-b) and a Phase I PK study in the US using
API-2. U.S. FDA reviewed the protocol and on Feb. 23, 2024, provided comments on our protocol revisions. Based upon FDA’s recommendations,
we have revised the Phase III protocol and developed the PK study protocol for submission to the U.S. FDA for their further review. They
suggested on May 23, 2024 that we provide a complete CMC information for the API-2, and a plan to establish comparability between API-1
and API-2 to enable them to review and possibly reach agreement on the protocols the Company designed to establish the safety and efficacy
of MCS-2.

2. We note your response to prior comment 1 and reissue in part. Please revise your disclosure throughout
your filing to remove language indicating that the comparability is an inevitable conclusion, such as “[O]nce the US FDA is convinced
about the comparability of API-1 and API-2....” You may discuss what happens if you are able to demonstrate comparability, but you
must indicate that to date you have not been able to do so and what your path forward is if you are unable to demonstrate comparability.

Please also state if you have had discussions with the
Taiwan regulator about the substitution of API-2 for API-1 in MCS-2. If you have not, or if the Taiwan regulator also requires comparability
studies, it is not appropriate to indicate that you have completed Phase 1 studies for PCP (API-1).

Response: In response to the Staff’s comments, the
Company has revised the disclosure on page 1, page 6, page 59, and page 113 of the Amendment No.3.

 Firstly, the botanical substance is under the same patent
owned by the company, we fully understand the harvesting, raw material preparation and API processing operations, thus we know and control
the steps that are relevant to the comparability analysis. We have done a series of analytical testing of characterization, specification
of the comparative API-1 and API-2. Thus, we are confident in the comparability between API-1 and API-2. We are continuing to collect
the necessary information from the API-2 supplier. Per FDA requirement in the FDA-WRO-20240523, we are presently drafting
our plan to establish comparability between API-1 and API-2. We will then request a CMC meeting with FDA later this year to provide complete
CMC documentation to the Agency.

 Secondly, The PCP Phase II study using API-1 has been completed.
We have not yet discussed API-2 with TFDA because the PCP Phase II study using API-1 is in the late stage of Source Data Verification
(“SDV”). Once the Clinical Study Report for PCP using API-1 is available, and the comparability between API-1 and API-2 is
confirmed, we will meet with TFDA to talk about the feasibility of a Phase III PCP study.

3. In response to prior comment 1 you state that you are preparing CMC information for API-2, are planning
to establish comparability between API-1 and API-2, and once the FDA is convinced about the comparability you will then initiate the MCS-2
Phase III and Phase I PK study. Please revise your disclosure to state that you currently do not have an API-2 supplier and that you cannot
proceed until you identify a supplier of API-2. Please also include such disclosure throughout your prospectus where you discuss PCP,
including but not limited to pages 6, 109, and 124. Additionally include a risk factor discussion addressing the potential consequences
if the FDA does not agree that API-1 is comparable to API-2.

Response: In response to the
Staff’s comments, the Company has revised the disclosure on page 1, page 7, page 113, page 117, page 133, and page 137 of the
Amendment No.3.

We do have an API-2 supplier that we
are currently working with to collect the batch information and CMC documentation. We are performing analytical testing for batch analysis
and comparison. We will then request a CMC meeting with FDA to provide complete CMC documentation to the Agency.

If the U.S. FDA concur that API-1 and
API-2 are similar and comparable, we will sign the quality agreement with this API-2 supplier. If there is any possibility that FDA does
not agree that API-1 and API-2 are comparable, we may work with another supplier who is able to meet the comparability.

    2

4. In response to prior comment 4 you state that you plan to demonstrate that API-1 and API-2 are comparable
to be able to rely on all prior trials. You also state that due to a failed MCS-2-US-a study you will conduct an additional Phase III
pivotal study in the US using API-2. Please clarify, if accurate, that you must first conduct API-1 and API-2 comparability studies and
if the FDA accepts such results and determines that API-1 and API-2 are comparable, only then will you be able to conduct the additional
Phase III pivotal study using API-2. Further, you also state that your plans will be discussed at the CMC meeting. Clarify, as you do
on page 2, that you received a denial notice from the FDA on May 23, 2024 for a CMC meeting.

Response: In response to the Staff’s
comments, the Company has revised the disclosure on page 1, page 3, page 7, page 113, page 117, page 133, and page 137 of the Amendment No.3.

Yes. We must conduct API-1 and API-2
comparability studies first and if the FDA accepts such results and determines that API-1 and API-2 are comparable, only then we will
be able to conduct the additional Phase III pivotal study using API-2.

FDA did not deny our CMC meeting request.
In fact, we have not submitted the request yet. We requested a Type B meeting on May 14, 2024 to discuss about the Phase I and Phase III
study protocols. FDA indicated in the May 23, 2024 notice that it is premature for this stage of drug development. FDA suggested that
instead we provide complete CMC information for API-2 and our plan to establish comparability between API-1 and API-2.

We are presently drafting the comparability
plan to include all the necessary data between API-1 and API-2. After we have collected all the comparability CMC data and documentation,
we will request the CMC meeting with FDA. After FDA accepts the comparability data, we will initiate the Phase I PK and Phase III pivotal
study using API-2. If FDA does not agree that API-1 and API-2 are comparable, we will need to work with other API vendor to demonstrate
the comparability that meet U.S. FDA’s requirements.

5. We note your response to comment 5 and 6. Your pipeline table should provide one line for each product
candidate being developed to address a single indication. The purpose of the pipeline table is not to depict the alternative ways you
may develop the same product candidate. Currently, your table depicts three lines depicting MCS-2 being developed to address BPH/LUTS.
Please revise your table to remove two of the lines depicting MCS-2 for BPH/LUTS as they are not additional candidates, they are alternative
ways that you may attempt to develop MCS-2 for BPH/LUTS. The line item that should be depicted in the table is the one that depicts the
method of development you are actively pursuing with the FDA.

If you are able to rely on trials performed using
API-1, it is not appropriate to include a separate line item in your table indicating that you have a separate product candidate for MCS-2
(API-1). If the FDA determines that API-1 and API-2 are sufficiently comparable to rely on the clinical trials performed using API-1,
then you may reflect the completion of the successful trials using API-1 in your pipeline table for the line item depicting the development
of MCS-2 (API-2). Until the FDA has made that comparability determination, such results relating to API-1 relate to a development pathway
that you are not currently able to pursue due to the fact that API-1 is currently not available. Similarly, if the new Phase III study
using API-2 is successful and you are able to demonstrate to the FDA that API-1 and API-2 are sufficiently comparable, then you will be
able to rely on the MCS-2-TWN-a study in the pipeline table if you have been able to re-analyze the data from the study to successfully
demonstrate to the FDA that it is reliable.

We also note your table indicates you are developing
PCP (API-1) for Prostate Cancer in Taiwan. Please explain how you are pursuing this using API-1 given that API-1 is not currently available.
Alternatively, remove it from your pipeline table.

Response: In response to the Staff’s
comments, the Company has revised the disclosure on page 3, page 4 and page 110 of the Amendment No.3.

    3

Each of the lines are important to
our plans. Although the pipeline table depicts three lines for MCS-2, the first two lines properly depict the completed four Phase III
studies using API-1. Another line depicts the alternative forthcoming studies using API-2, once FDA agrees with our comparability determination.
At that time, Phase III studies using API-1 would be applicable to the overall approval process informing the later studies using API-2

We have revised the pipeline table,
separating the drug candidates using API-1 and API-2. We have clarified in the table that the clinical results of the candidates using
API-1 can only be used if the U.S. FDA is convinced of the comparability of API-1 and API-2. As of this date, the Company is still in
the process of preparing the information required by the U.S. FDA and has not yet have the CMC meeting with FDA to discuss about the comparability
of API-1 and API-2.

The Phase II PCP study was initiated
in Taiwan in 2014 using API-1, and the study enrollment and treatment phase is completed without being affected by the currently unavailable
API-1. If the U.S. FDA concur that API-1 and API-2 are comparable, and when the CSR for the PCP study is available, we will discuss with
TFDA about conducting the Phase III PCP study. Therefore, it is also important to keep this line.

6. We note your response to prior comment 8 and reissue our comment. Please refer to page 2 of 7 from
the FDA correspondence dated June 26, 2023 you provided in response to our request on May 31, 2024, which states:

“Because of the heterogeneous nature of a botanical
drug and uncertainty about its active constituents a critical issue for botanical drugs is ensuring that the therapeutic effect for drug
batches is consistent. In general, therapeutic consistency can be supported by a ‘totality of the evidence’ approach, including botanical
raw material control, quality control, by chemical test(s), manufacturing control, a biological assay (if needed) and clinical data. Seemingly
minor changes in the API source and/or manufacturing process may result in a meaningful difference in the clinical effects and raise concerns
about the applicability of earlier pharmacological, nonclinical and clinical data.”

See also pages 2-3 of 10 which states, “any changes
(e.g. changes in the agricultural sites, agricultural and collection practices and/or processing/manufacturing methods) should be assessed
carefully to determine if the BDS and the botanical drug product (BDP) batches produced after such a proposed change would be sufficiently
similar pharmacologically and/or therapeutically to batches prior to such a change.”

Please note the potential impact of these “seemingly
minor changes” apply to changes in suppliers of the active pharmaceutical ingredient as well as the change in the active pharmaceutical
ingredient provided by the supplier of API-1 prior to its relocation and following its relocation. Therefore, in order to produce MCS-2
using API-1 following a relocation, you would have to demonstrate comparability again. Please revise your disclosure to clarify that if
you intend to develop MCS-2 using API-1 if it becomes available, you will have to demonstrate comparability again. If you are unable to
demonstrate comparability, you will have to perform more clinical trials.

Response: In response to the Staff’s
comments, the Company has revised the disclosure on page 5, page 111 and page 126 of the Amendment No.3.

 We interpret the FDA’s use of the word “source”
to not be a reference to the physical location of a manufacturing facility but rather to the entity responsible for manufacturing an API,
the raw materials used to produce the API, the manufacturing process, and compliance with FDA’s current good manufacturing practices
(GMPs). Therefore, in the case that the same entity manufactures an API in different physical locations but uses identical raw materials
and the same patented manufacturing process in compliance with FDA’s GMPs, the mere difference in the location of the manufacturing
site is unlikely to result in significant differences in the final API. We understand FDA advice in the 20230626-WRO, which is a kind
reminder to ensure comparability from any change. We will work with the API vendors to follow FDA guidance to demonstrate comparability.

    4

7. Please provide us with a copy of the FDA meeting minutes from your January 20, 2013 CMC meeting in
which the FDA staff encouraged you to select multiple vendors for the botanical raw material and advised you to identify more raw material
vendors to avoid any potential supply shortages in the early stages. The June 26, 2023 FDA correspondence you provided indicates that
“minor changes in the API source and/or manufacturing process may result in a meaningful difference in the clinical effects and raise
concerns about the applicability of earlier pharmacological, nonclinical and clinical data” which appears inconsistent with this
advice.

Response: In response to the Staff’s
comments, we have uploaded the FDA meeting minutes to the SEC document sharing system.

During the EOP2 CMC meeting held on January 30,
2013, FDA encouraged us to select multiple vendors of the botanical raw material for making the
multipl

July 19, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 2 to Registration Statement on Form F-1
Filed June 21, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our May 31, 2024 letter.
Amendment No. 2 to Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.Please revise the discussion of your current plans to develop MCS-2 (API-2) to clarify the
FDA’s concerns communicated on pages 1-2 of its February 23, 2024 correspondence,
which you provided in response to our May 31, 2024 request. The communication
indicates that your proposed plan to conduct one phase 1 study and one phase 3 efficacy
study using your product containing API-2 faces significant challenges. Please update
your Summary to briefly describe the FDA’s concerns and provide a more fulsome
discussion of these concerns in the Business section.
We note your response to prior comment 1 and reissue in part. Please revise your
disclosure throughout your filing to remove language indicating that the comparability is 2.

July 19, 2024
Page 2
an inevitable conclusion, such as "[O]nce the US FDA is convinced about the
comparability of API-1 and API-2...."  You may discuss what happens if you are able to
demonstrate comparability, but you must indicate that to date you have not been able to
do so and what your path forward is if you are unable to demonstrate comparability.
Please also state if you have had discussions with the Taiwan regulator about the
substitution of API-2 for API-1 in MCS-2. If you have not, or if the Taiwan regulator also
requires comparability studies, it is not appropriate to indicate that you have completed
Phase 1 studies for PCP (API-1).
3.In response to prior comment 1 you state that you are preparing CMC information for
API-2, are planning to establish comparability between API-1 and API-2, and once the
FDA is convinced about the comparability you will then initiate the MCS-2 Phase III and
Phase I PK study. Please revise your disclosure to state that you currently do not have an
API-2 supplier and that you cannot proceed until you identify a supplier of API-2. Please
also include such disclosure throughout your prospectus where you discuss PCP,
including but not limited to pages 6, 109, and 124. Additionally include a risk factor
discussion addressing the potential consequences if the FDA does not agree that API-1 is
comparable to API-2.
4.In response to prior comment 4 you state that you plan to demonstrate that API-1 and
API-2 are comparable to be able to rely on all prior trials. You also state that due to a
failed MCS-2-US-a study you will conduct an additional Phase III pivotal study in the US
using API-2. Please clarify, if accurate, that you must first conduct API-1 and API-2
comparability studies and if the FDA accepts such results and determines that API-1 and
API-2 are comparable, only then will you be able to conduct the additional Phase III
pivotal study using API-2. Further, you also state that your plans will be discussed at the
CMC meeting. Clarify, as you do on page 2, that you received a denial notice from the
FDA on May 23, 2024 for a CMC meeting.
We note your response to comment 5 and 6. Your pipeline table should provide one line
for each product candidate being developed to address a single indication. The purpose of
the pipeline table is not to depict the alternative ways you may develop the same product
candidate. Currently, your table depicts three lines depicting MCS-2 being developed to
address BPH/LUTS. Please revise your table to remove two of the lines depicting MCS-2
for BPH/LUTS as they are not additional candidates, they are alternative ways that you
may attempt to develop MCS-2 for BPH/LUTS. The line item that should be depicted in
the table is the one that depicts the method of development you are actively pursuing with
the FDA.

If you are able to rely on trials performed using API-1, it is not appropriate to include a
separate line item in your table indicating that you have a separate product candidate for
MCS-2 (API-1). If the FDA determines that API-1 and API-2 are sufficiently comparable
to rely on the clinical trials performed using API-1, then you may reflect the completion
of the successful trials using API-1 in your pipeline table for the line item depicting the
development of MCS-2 (API-2). Until the FDA has made that comparability
determination, such results relating to API-1 relate to a development pathway that you are
not currently able to pursue due to the fact that API-1 is currently not available. Similarly,
if the new Phase III study using API-2 is successful and you are able to demonstrate to the 5.

July 19, 2024
Page 3
FDA that API-1 and API-2 are sufficiently comparable, then you will be able to rely on
the MCS-2-TWN-a study in the pipeline table if you have been able to re-analyze the data
from the study to successfully demonstrate to the FDA that it is reliable.

We also note your table indicates you are developing PCP (API-1) for Prostate Cancer in
Taiwan. Please explain how you are pursuing this using API-1 given that API-1 is not
currently available. Alternatively, remove it from your pipeline table.
6.We note your response to prior comment 8 and reissue our comment. Please refer to page
2 of 7 from the FDA correspondence dated 26, 2023 you provided in response to our
request on May 31, 2024, which states:
"Because of the heterogeneous nature of a botanical drug and uncertainty about its active
constituents a critical issue for botanical drugs is ensuring that the therapeutic effect for
drug batches is consistent. In general, therapeutic consistency can be supported by a
'totality of the evidence' approach, including botanical raw material control, quality
control, by chemical test(s), manufacturing control, a biological assay (if needed) and
clinical data. Seemingly minor changes in the API source and/or manufacturing process
may result in a meaningful difference in the clinical effects and raise concerns about the
applicability of earlier pharmacological, nonclinical and clinical data."

See also pages 2-3 of 10 which states, "any changes (e.g. changes in the agricultural sites,
agricultural and collection practices and/or processing/manufacturing methods) should be
assessed carefully to determine if the BDS and the botanical drug product (BDP) batches
produced after such a proposed change would be sufficiently similar pharmacologically
and/or therapeutically to batches prior to such a change."

Please note the potential impact of these "seemingly minor changes" apply to changes in
suppliers of the active pharmaceutical ingredient as well as the change in the active
pharmaceutical ingredient provided by the supplier of API-1 prior to its relocation and
following its relocation. Therefore, in order to produce MCS-2 using API-1 following a
relocation, you would have to demonstrate comparability again. Please revise your
disclosure to clarify that if you intend to develop MCS-2 using API-1 if it becomes
available, you will have to demonstrate comparability again. If you are unable to
demonstrate comparability, you will have to perform more clinical trials.
7.Please provide us with a copy of the FDA meeting minutes from your January 20, 2013
CMC meeting in which the FDA staff encouraged you to select multiple vendors for the
botanical raw material and advised you to identify more raw material vendors to avoid
any potential supply shortages in the early stages. The June 26, 2023 FDA
correspondence you provided indicates that "minor changes in the API source and/or
manufacturing process may result in a meaningful difference in the clinical effects and
raise concerns about the applicability of earlier pharmacological, nonclinical and clinical
data" which appears inconsistent with this advice.
Risk Factors, page 17
Please include a risk factor addressing the possibility that the FDA does not agree that
API-1 and API-2 are sufficiently comparable. The discussion should address the FDA's
concerns related to changes in agricultural sites, agricultural and collection practices, 8.

July 19, 2024
Page 4
processing and manufacturing methods, etc. and the consequences if the FDA determines
that API-1 and API-2 are not sufficiently comparable.
9.Please include an additional risk factor discussing the FDA's stated concerns about your
proposed plan to conduct only one phase 1 study and one phase 3 efficacy study. The
discussion should identify the FDA's concerns you will have to address in order to
successfully develop MCS-2 (API-2), given your current plan and the potential
consequences, if you are unable to demonstrate to the FDA that your proposal is sufficient
to demonstrate safety and efficacy.
Leverage differentiated approaches to advance our development..., page 112
10.In response to prior comment 14 you state you plan to complete all source data
verification, database lock and statistical analysis, and draft the clinical study report. Such
steps appear necessary for you to advance your product candidate. You also state on page
1 that you do not plan to discuss PCP with the TFDA until after you have conducted
comparability studies. Please clarify if this process is dependent on first selecting an API-
2 supplier and conducting successful comparability studies or if you will be verifying and
analyzing the data at the same time you are performing comparability studies. Please
clarify that if the comparability studies are not successful, the PCP clinical trials will have
to be performed again using PCP (API-2).
Our Drug Candidates
Phase II Clinical Studies, page 118
11.In response to prior comment 15 we note the additional disclosure provided under Clinical
Data and Phase I Clinical Studies. Please also include disclosure under Phase II and Phase
III Clinical Studies, on pages 118 and 119 respectively, to state that if your comparability
studies are not accepted by the FDA you will need to conduct additional Phase II and
Phase III studies to continue your clinical development.
Phase III Clinical Studies, page 119
12.We note your response to prior comment 16 and reissue in part. Please clarify here, as you
do on page 123, that the remaining data you are referring to is the data from the two Phase
III studies conducted in Taiwan and the one Phase III US open label extension study. Also
include a discussion here and on page 123 that the U.S. FDA has expressed concerns
regarding the reproducibility of some of the reported efficacy results for Study MCS-2-
TWN-a as you do on page 1.
13.We note your response to prior comment 17. Specifically, that you will not need to
reproduce the Phase III study in US (MCS-2-US-a) if the US FDA has approved the
comparability of API-1 and API-2 and the results of an additional Phase III study (MCS-
2-US-b) using API-2. Provide the basis for your determination that the FDA will rely on
results of trials that failed to demonstrate a difference between the treatment groups for
the primary efficacy endpoint in the intent-to-treat population. Please also include
additional disclosure stating that if the FDA does not approve your comparability studies
you will need to reproduce MCS-2 (API-1) Phase III study in the US because it failed to
show a difference between treatment groups for the primary efficacy endpoint in the
intent-to-treat population.

July 19, 2024
Page 5
14.We note that in response to prior comment 18 you removed the US-a + TWN-a/ITT
results from Table 1 and 2. However, we note that your disclosure still contains
statements such as "[a]ccording to the results of phase III clinical trials after pooling US-a
and TWN-a..." Given your disclosure throughout your prospectus that the FDA
determined your Phase III clinical trial in the U.S. failed to show a difference between the
treatment groups for the primary efficacy endpoint in the intent- to-treat population,
pooling the results masks the different outcomes from the two trials. Please amend to
separately present the results of each of the Phase III trials completed throughout your
filing.
            Please contact Mary Mast at 202-551-3613 if you have questions regarding comments on
the financial statements and related matters. Please contact Doris Stacey Gama at 202-551-3188
or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ross Carmel, Esq.

CORRESP
1
filename1.htm

June 21, 2024

Via
EDGAR

Division
of Corporation Finance

Office
of Life Sciences

Securities
and Exchange Commission

Washington,
D.C. 20549

    Attn.:
    Ibolya Ignat

Mary
Mast

Doris
Stacey Gama

Joe
McCann

    Re:
    Jyong
    Biotech Ltd.

    Response to the Staff’s Comments on

    Registration
    Statement on Form F-1/A

    Filed
    on May 8, 2024 (File No. 333-277725)

Dear
Sir and Madam:

On
behalf of our client, Jyong Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff
(the “Staff”) of the Securities and Exchanges Commission (the “Commission”) this letter setting
forth the Company’s responses to the comments contained in the Staff’s letter dated May 31, 2024 on the Company’s registration
statement on Form F-1/A filed on May 8, 2024 (the “Registration Statement”). Concurrently with the submission
of this letter, the Company is filing amendment No.2 to Registration Statement (the “Amendment No.2”) via EDGAR to
the Commission.

The
Staff’s comments are repeated below in bold and are followed by the Company’s responses. We have included page references
in the Amendment No.1 where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein
have the meanings set forth in the Amendment No.1.

Prospectus
Summary

Overview,
page 1

1.
We note your disclosure that PCP is the same drug as MCS-2, and that you relied on the safety and tolerability profile observed in the
MCS-2 Phase II clinical trial and proceeded directly to a Phase II trial. Please clarify that you were relying on the safety and tolerability
profile of MCS-2 with API-1, which is no longer available. Explain why you believe it is appropriate to indicate that PCP is in Phase
II, when the data you are relying on for safety and tolerability information is based on a trial conducted using a different active pharmaceutical
ingredient. Clarify whether you have had discussions with the Taiwan regulator about the substitution of API-2 for API-1 in MCS-2 and
PCP.

Response:
In response to the Staff’s comments, the Company has revised the disclosure on page 1of the Amendment No.2.

PCP
is the same drug as MCS-2, using the same drug substance API-1, for different indication. Therefore, we relied on the safety profiles
from MCS-2 early-stage research till the Phase III clinical trials for the PCP Phase 2 study initiated in 2014. PCP Phase 2 study enrollment
and treatment phase using API-1 is completed now and it is in the SDV (source data verifications) stage before drafting the clinical
study report (CSR). We have not yet discussed with Taiwan regulatory about the potential PCP Phase III clinical trial using API-2.

 U.S.FDA
suggested we provide complete Chemistry, Manufacturing, and Controls (CMC) information on our active pharmaceutical ingredient-2 (API-2)
and a plan to establish comparability between API-1 and API-2. The goal is to reach agreement with FDA on the comparability of API-1
and API-2, as well as the protocols designed to establish the safety and efficacy of MCS-2 during the CMC meeting. Once U.S. FDA is convinced
about comparability of API-1 and API-2 we will conduct the MCS-2 Phase 3 study and the Phase I PK study using API-2. As previously noted,
API-1 and API-2 are similar drug substances covered by the same patent owned by the Company. After FDA is convinced about comparability
of API-1 and API-2, the Company could use either to make the same Botreso softgels. In the Company’s opinion, it is still possible
that we will have the chance to use both API-1 and API-2 at the marketing stage.

2.
Please clarify whether MCS-2-US-a and MCS-2-TWN-a were pivotal or open label extension studies.

Response:
In response to the Staff’s comments, the Company has revised the disclosure on page 1 of the Amendment No.2.

The
MCS-2-US-a and MCS-2-TWN-a were the two Phase 3 pivotal studies, and the MCS-2-US-c and MCS-2-TWN-c were the two open label extension
studies.

3.
We note your response to our prior comment 3, please provide us with copies of all correspondence with the FDA since submitting your
meeting request to the FDA on April 14, 2023 and continue to update your disclosure to the extent you engage in material discussions
with the FDA related to the development of your product candidates.

Response:
We have uploaded all our correspondence with the U.S. FDA since April 14, 2023 up to the present to the SEC data site. All of the correspondence
has been reviewed by our FDA counsel, Olsson Frank Weeda Terman Matz PC, and the material comments have been disclosed in Amendment No.
2 accordingly.

4.
We note your response to prior comment 4 and reissue in part. You state that the FDA informed you that the information you provided about
API-2 was not sufficient to demonstrate comparability to API-1 "including with respect to a statistically significant difference
between MCS-2 and placebo in the primary efficacy endpoint in a clinical study." Please identify the clinical study indicating the
statistical difference between MCS-2 and the placebo and clarify whether it was a Phase III pivotal trial.

Further,
discuss the purpose of assessing the comparability of API-2 to API-1 on individual studies. We note the FDA considers MCS-2 API-2 to
be an entirely new drug. Additionally, we note the FDA commented it will need more information related to how you would demonstrate comparability
between API-1 and API-2. Please explain why this information is necessary, are you trying to continue to rely on data from trials using
MCS- 2 API-1 or are you continuing to try to demonstrate that API-2 is comparable to API-1, such that all of the prior trials can be
used to support a new NDA? Generally, the assumption is that MCS-2 API-2 is an entirely new drug would mean that it would be developed
without the need to demonstrate comparability to MCS-2 API-1.

Response:
In response to the Staff’s comments, the Company has revised the disclosure on page 2 of the Amendment No.2.

In
our Type C meeting request submitted to FDA on April 14, 2023, we only provided the preliminary comparative drug substance and drug product
specifications between API-1 and API-2. FDA stated that this was not sufficient to demonstrate comparability of API-2 to API-1. FDA’s
comments about the “statistically significant difference between MCS-2 and placebo in the primary efficacy endpoint in a clinical
study”, the agency is referring to the Phase 3 pivotal studies.

    2

The
purpose of our assessing the comparability of API-2 to API-1 on individual studies is to be able to continue to rely on data from trials
using MCS-2 API-1. Once we satisfy FDA that we have demonstrated that API-2 is comparable to API-1, the prior trials can be used as support
for a new NDA filing. This will be discussed with the U.S. FDA at the CMC meeting, in order to get U.S. FDA feedback. Our goal for the
CMC meeting is to obtain the U.S. FDA’s concurrence that API-1 and API-2 are comparable and similar drug substances. As the U.S.
FDA requires additional clinical information, we plan to conduct a new Phase III study in the U.S. using API-2 because the previous Phase
3 pivotal MCS-2-US-a study using API-1 is insignificant in the ITT population.

5.
In response to prior comment 5 you state that you conducted four Phase III clinical trials for MCS-2 using API-1 in the U.S. and Taiwan,
that one pivotal Phase III clinical trial in the U.S. failed to show a difference between treatment groups for the primary efficacy endpoint
in the intent-to-treat population, and that you will not conduct new Phase III trial using API-1. Additionally, we note that the FDA
had concerns regarding the reported efficacy results of MCS-2-TWN-a and your prior acknowledgement that had you not withdrawn your NDA,
the substantive issues would have prevented the agency from approving the NDA. For these reasons, it is not appropriate to include the
product candidate in your pipeline table, which indicates it continues to be part of our pipeline, without indicating that the clinical
work has not been completed. The disclosure in the notes under the table indicating that one Phase III trial failed and another one yielded
questionable results does not mitigate the fact that your table depicts a scenario where the candidate has completed all clinical trials
necessary to move forward in the development process. To the extent that MCS-2 (API-1) is material to your current operations, please
revise your table accordingly.

Response:
In response to the Staff’s comments, the Company has revised the pipeline on page 3 and 107 of the Amendment No.2.

We
had already conducted two pivotal Phase III clinical trials and two open label extension Phase III clinical trials using API-1. Our goal
for the CMC with the U.S. FDA is for the agency to accept the similarity and comparability of API-1 and API-2, after which we plan to
conduct a new Phase III study in the U.S. using API-2. FDA’s concern on the reproducibility issue of MCS-2-TWN-a data is due to
the data system, because the original analysis results in the clinical study report (CSR) were done by a previous CRO, based on the non-CDISC
data sets (raw data sets). FDA requested CDISC-compliant data sets to be delivered. Therefore, the Company retained another CRO to created
CDISC-compliant data sets for the final deliverable. However, the Company did not re-analyze the MCS-2-TWN-a study using the CDISC-compliant
data sets. If our new Phase 3 study using API-2 is successful, we are proposing to re-analyze the MCS-2-TWN-a study data using CDISC
data sets. Then the results of our Phase III clinical trials using API-1 will be supportive information for our NDA, together with the
new Phase 3 trial and Phase 1 PK study using API-2. This is our reasoning for keeping the candidates in the pipeline table.

6.
We note your response to comment 7 and your disclosures that API-1 is not currently available. Please limit your pipeline table to product
candidates that are material to your current operations, as opposed to candidates you speculate you may be in a position to develop in
the future. To the extent you are hoping to develop MCS-2 (API-1) in the future if the supply becomes available again, you may include
a discussion of MCS-2 (API-1) in the business section. Please note that if you do, you should include a discussion of the clinical trials
that may have to be repeated and/or additional work that may be necessary to demonstrate the comparability between API-1 and API-2. Please
also include a risk factor discussing your intentions to further develop MCS-2 (API-1) if API-1 becomes available to you again. The discussion
should highlight the expenses related to developing this drug candidate, which would be largely redundant of MCS-2 (API-2) if it had
been approved, and that any sales of MCS-2 (API-1) would likely be at the expense of sales of MCS-2 (API-2), assuming approval of both
candidates.

Response:
In response to the Staff’s comments, the Company has revised the disclosure on page 2 of the Amendment No.2.

During
our CMC meeting on January 30, 2013, the U.S. FDA encouraged us to select multiple vendors for the botanical raw material. The U.S. FDA
advised us to identify more raw material vendors to avoid any potential supply shortages in the early stages. The source for API-1 may
again become available in the future and, if so, we may seek to use it as the source for further drug development, thus we have decided
to retain MCS-2 (using API-1) in our pipeline. If we are able to satisfy U.S. FDA that API-1 and API-2 are comparable, and the U.S. FDA
is convinced the comparability between API-1 and API-2, we will not need to conduct redundant studies using API-1. Moreover, we are planning
the CMC meeting with U.S. FDA, one purpose of which is to seek the U.S FDA’s concurrence that API-2 is comparable to API-1. Those
plans are no more speculative than the fact that we are engaged in an ongoing drug approval process with the U.S. FDA. It is not uncommon
to maintain redundant API sources for the same finished drug to minimize the risk of shortages.

    3

7.
We note your response to prior comment 6 and reissue in part. Your pipeline table indicates that you have completed Phase I and Phase
II trials for MCS-2 (API-2) but you state that the FDA considers MCS-2 API-2 a new drug development program, that new Phase I PK and
Phase III studies are required, and that you have only submitted a Phase I PK synopsis to the FDA on December 12, 2023 for review and
comments. If true, please clarify that you have not completed the pharmacokinetic study using API-2 and shorten your arrow to properly
reflect the status of MCS-2 (API-2). To the extent that that the FDA has agreed that it will not require a Phase II trial assuming successful
completion of Phase I trial(s), we will not object to a visual representation that the Phase II has been completed once you have completed
Phase I. However, we object to the current representation that you have completed Phases I and II, when neither has been completed.

Response:
In response to the Staff’s comments, the Company has revised the pipeline on page 3 and 107 of the Amendment No.2.

8.
In response to comment 10 you state that the supplier of API-1 withdrew their consent to reference their DMF due to lack of availability
of API-1 but if the source were to become available again you may seek to use it as a source to further drug development of MCS-2 using
API-1. Please expand the discussion to clarify that the withdrawal of the DMF complicated your attempt to demonstrate that API-1 and
API-2 are comparable. Additionally, expand your discussion of your potential plans to use API-1 in later studies to clarify that you
would be required to conduct additional Phase III trial(s) because your original Phase III trial in the US failed to show a difference
between treatment groups for the primary efficacy endpoint in the intent-to-treat population.

Response:
In response to the Staff’s comments, the Company has revised the disclosure on page 4 of the Amendment No.2.

The
supplier of API-1 withdrew their consent to reference their DMF, because they plan to relocate and restructure the manufacturing
facility. Consequently, the supplier is not currently manufacturing API-1. This does not complicate our attempt to demonstrate to
U.S. FDA that API-1 and API-2 are comparable. Rather, it necessitated our reliance on API-2. If we successfully satisfy the U.S FDA
that API-2 is comparable to API-1, then once the supplier of API-1 reinitiates production we will be assured of adequate supply of
our drug substance to expand our market. Since our Phase 3 pivotal study in the U.S. using API-1 is insignificant in the ITT
population, we plan to conduct additional Phase 3 trial in the U.S. using API-2.

Risk
Factors

The
U.S. FDA has concluded that one of our four Phase III trials failed..., page 23

9.
In response to prior comment 14 you state that you plan to conduct two studies in the US in late 2024 that may take approximately one
to two years and that the study budget cannot be determined at present and will need to be estimated after further comments from the
US FDA. Please clarify in the risk factor that the one to two years and the study budget that you will need is in addition to what was
originally allocated and is a result of failing Phase III trials and not having access to API-1 supplies.

Response:
In response to the Staff’s comments, the Company has revised the disclosure on page 24 of the Amendment No.2.

    4

10.
Please include a separate risk factor discussing your dependence on suppliers of API and that the inability of a supplier to provide
API-1 has led to further delays in the development of MCS-2. Your discussion should clarify the additional time and expense incurred
as a result of having to replace API-1 and the potential consequences if API-2 were to become unava

United States securities and exchange commission logo
May 31, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 1 to Registration Statement on Form F-1
Filed May 8, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our April 4, 2024 letter.
Amendment No. 1 to Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.We note your disclosure that PCP is the same drug as MCS-2, and that you relied on the
safety and tolerability profile observed in the MCS-2 Phase II clinical trial and proceeded
directly to a Phase II trial. Please clarify that you were relying on the safety and
tolerability profile of MCS-2 with API-1, which is no longer available. Explain why you
believe it is appropriate to indicate that PCP is in Phase II, when the data you are relying
on for safety and tolerability information is based on a trial conducted using a different
active pharmaceutical ingredient. Clarify whether you have had discussions with the
Taiwan regulator about the substitution of API-2 for API-1 in MCS-2 and PCP.

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 May 31, 2024 Page 2
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
May 31, 2024
Page 2
2.Please clarify whether MCS-2-US-a and MCS-2-TWN-a were pivotal or open label
extension studies.
3.We note your response to our prior comment 3, please provide us with copies of all
correspondence with the FDA since submitting your meeting request to the FDA on April
14, 2023 and continue to update your disclosure to the extent you engage in material
discussions with the FDA related to the development of your product candidates.
4.We note your response to prior comment 4 and reissue in part. You state that the FDA
informed you that the information you provided about API-2 was not sufficient to
demonstrate comparability to API-1 "including with respect to a statistically significant
difference between MCS-2 and placebo in the primary efficacy endpoint in a clinical
study." Please identify the clinical study indicating the statistical difference between
MCS-2 and the placebo and clarify whether it was a Phase III pivotal trial.

Further, discuss the purpose of assessing the comparability of API-2 to API-1 on
individual studies. We note the FDA considers MCS-2 API-2 to be an entirely new drug.
Additionally, we note the FDA commented it will need more information related to how
you would demonstrate comparability between API-1 and API-2. Please explain why this
information is necessary, are you trying to continue to rely on data from trials using MCS-
2 API-1 or are you continuing to try to demonstrate that API-2 is comparable to API-1,
such that all of the prior trials can be used to support a new NDA? Generally, the
assumption is that MCS-2 API-2 is an entirely new drug would mean that it would be
developed without the need to demonstrate comparability to MCS-2 API-1.
5.In response to prior comment 5 you state that you conducted four Phase III clinical trials
for MCS-2 using API-1 in the U.S. and Taiwan, that one pivotal Phase III clinical trial in
the U.S. failed to show a difference between treatment groups for the primary efficacy
endpoint in the intent-to-treat population, and that you will not conduct new Phase III trial
using API-1. Additionally, we note that the FDA had concerns regarding the reported
efficacy results of MCS-2-TWN-a and your prior acknowledgement that had you not
withdrawn your NDA, the substantive issues would have prevented the agency from
approving the NDA. For these reasons, it is not appropriate to include the product
candidate in your pipeline table, which indicates it continues to be part of our pipeline,
without indicating that the clinical work has not been completed. The disclosure in the
notes under the table indicating that one Phase III trial failed and another one yielded
questionable results does not mitigate the fact that your table depicts a scenario where the
candidate has completed all clinical trials necessary to move forward in the development
process. To the extent that MCS-2 (API-1) is material to your current operations, please
revise your table accordingly.
6.We note your response to comment 7 and your disclosures that API-1 is not currently
available. Please limit your pipeline table to product candidates that are material to your
current operations, as opposed to candidates you speculate you may be in a position to
develop in the future. To the extent you are hoping to develop MCS-2 (API-1) in the

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future if the supply becomes available again, you may include a discussion of MCS-2
(API-1) in the business section. Please note that if you do, you should include a discussion
of the clinical trials that may have to be repeated and/or additional work that may be
necessary to demonstrate the comparability between API-1 and API-2. Please also include
a risk factor discussing your intentions to further develop MCS-2 (API-1) if API-1
becomes available to you again. The discussion should highlight the expenses related to
developing this drug candidate, which would be largely redundant of MCS-2 (API-2) if it
had been approved, and that any sales of MCS-2 (API-1) would likely be at the expense of
sales of MCS-2 (API-2), assuming approval of both candidates.
7.We note your response to prior comment 6 and reissue in part. Your pipeline table
indicates that you have completed Phase I and Phase II trials for MCS-2 (API-2) but you
state that the FDA considers MCS-2 API-2 a new drug development program, that new
Phase I PK and Phase III studies are required, and that you have only submitted a Phase I
PK synopsis to the FDA on December 12, 2023 for review and comments. If true, please
clarify that you have not completed the pharmacokinetic study using API-2 and shorten
your arrow to properly reflect the status of MCS-2 (API-2). To the extent that that the
FDA has agreed that it will not require a Phase II trial assuming successful completion of
Phase I trial(s), we will not object to a visual representation that the Phase II has been
completed once you have completed Phase I. However, we object to the current
representation that you have completed Phases I and II, when neither has been completed.
8.In response to comment 10 you state that the supplier of API-1 withdrew their consent to
reference their DMF due to lack of availability of API-1 but if the source were to become
available again you may seek to use it as a source to further drug development of MCS-2
using API-1. Please expand the discussion to clarify that the withdrawal of the DMF
complicated your attempt to demonstrate that API-1 and API-2 are comparable.
Additionally, expand your discussion of your potential plans to use API-1 in later studies
to clarify that you would be required to conduct additional Phase III trial(s) because your
original Phase III trial in the US failed to show a difference between treatment groups for
the primary efficacy endpoint in the intent-to-treat population.
Risk Factors
The U.S. FDA has concluded that one of our four Phase III trials failed..., page 23
9.In response to prior comment 14 you state that you plan to conduct two studies in the US
in late 2024 that may take approximately one to two years and that the study budget
cannot be determined at present and will need to be estimated after further comments from
the US FDA. Please clarify in the risk factor that the one to two years and the study
budget that you will need is in addition to what was originally allocated and is a result of
failing Phase III trials and not having access to API-1 supplies.
10.Please include a separate risk factor discussing your dependence on suppliers of API and
that the inability of a supplier to provide API-1 has led to further delays in the
development of MCS-2. Your discussion should clarify the additional time and expense

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incurred as a result of having to replace API-1 and the potential consequences if API-2
were to become unavailable. Given that this is a separate risk, it should not be discussed
as part of the risk related to the failed clinical trials.
Certain of our facilities were mortgaged. If the mortgagees enforce the mortgage..., page 40
11.We note your response to prior comment 16. Please state whether you are current on your
mortgages secured by your properties.
Benign Prostatic Hyperplasia, page 101
12.We note your response to comment 19 and your revised disclosure indicating that you will
further discuss business cooperation with the API-1 supplier within the next 5 years.
Given the speculative nature of your plans with respect to the supplier of API-1, the
current lack of convincing evidence about the comparability of API-1 and API-2, and the
fact that API-2 has not yet undergone any clinical trials, please remove the table
comparing BPH drugs to MCS-2 (API-1) from your disclosure.
Leverage differentiated approaches to advance our development of other candidates..., page 112
13.Please describe the serious adverse events and quantify the number of each type of event.
14.Please explain what you mean when you indicate you intend to "expedite our clinical
development of PCP." How do you expedite the clinical development?
Our Drug Candidate
Clinical Data, page 115
15.We note your disclosure on pages 116 and 118 where you clarify that the data in Phase I
and Phase III clinical studies pertains to clinical trials utilizing API-1. Please also disclose
that you will be conducting new studies using API-2.
Phase III Clinical Studies, page 118
16.In response to prior comment 25 you state here and on page 123 that "[d]espite the pivotal
Phase III clinical trial for MCS-2 (API-1) in the U.S. failing to demonstrate a difference
between treatment groups for the primary efficacy endpoint in the intent-to-treat
population, the remaining data still indicated that the overall results indicated that MCS-2
(API-1) softgels could reduce the I-PSS total score." If true, please clarify that remaining
data you are referring to is the two Phase III studies conducted in Taiwan and also include
a discussion that the U.S. FDA has expressed concerns regarding the reproducibility of
some of the reported efficacy results for Study MCS-2-TWN-a as you do on page 1.
17.We note your study completion dates table on page 120. Please include a short description
that your MCS-2 (API-1) Phase III study in the US will need to be reproduced because it
failed to show a difference between treatment groups for the primary efficacy endpoint in
the intent-to-treat population.

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Jyong Biotech Ltd.
May 31, 2024
Page 5
18.We note your response to prior comment 26. Given your disclosure throughout your
prospectus that the FDA determined your Phase III clinical trial in the U.S. failed to show
a difference between the treatment groups for the primary efficacy endpoint in the intent-
to-treat population, pooling the results masks the different outcomes from the two trials.
Please amend to separately present the results of each of the Phase III trials completed.
19.You state on page 122 that due to the U.S. FDA's new statistical analysis standards issued
in December 2016 you had to re-create your data to match the U.S. FDA's electronic
submission gateway which resulted in a delay in your NDA submission in late 2021.
Please clarify that that NDA was withdrawn and that you currently do not have an NDA
on file with the FDA.
Suppliers, page 130
20.In response to prior comment 27 you state that you are currently evaluating two to three
suppliers of API-2. Please include disclosure throughout your prospectus that you
currently do not have an API-2 supplier and that in order to begin your additional Phase
III and Phase I PK studies you will first need to identify a supplier of the raw materials
needed to produce API-2.
Consolidated financial statements
Notes to Consolidated financial statements
Note 18. Subsequent Events, page F-27
21.Your response to prior comment 29 did not fully address our comment. Please provide us
the accounting analysis we originally requested. At a minimum, please address the
following:
•Your analysis should support your presentation of the land use rights now classified
as Restricted Assets, and of all related activities reported in your financial statements
as of December 31, 2023, in light of the legal developments you disclose and the
guidance in ASC 855-10-55-1. Please include references to the paragraphs within the
authoritative accounting literature you relied on that support your accounting and
presentation.
•Tell us why Parent Company Only financial statements are not required to be
presented in your filing. Refer to the guidance in Rules 5-04 and 12-04 of Regulation
S-X and ASC 810-10-45-11.
•Please provide us supplementally in tabular form a condensed consolidating schedule
for the holding company and its subsidiaries that disaggregates the operations and
depicts the financial position, cash flows, and results of operations as of the same
dates and for the same periods for which audited consolidated financial statements
are required. The schedule should present major line items, subtotals and
disaggregated intercompany amounts, and investment in subsidiaries. Clarify which
line items relate to the assets that are affected by the latest ruling in the litigation.

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Fu-Feng Kuo
Jyong Biotech Ltd.
May 31, 2024
Page 6
            Please contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 if you have
questions regarding comments on the financial statements and related matters. Please contact
Doris Stacey Gama at 202-551-3188 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Ross Carmel, Esq.

CORRESP
1
filename1.htm

May 8, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

Mary Mast

Doris Stacey Gama

Joe McCann

    Re:
    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Registration Statement on Form F-1

    Filed on March 7, 2024 (File No. 333-277725)

Dear Sir and Madam:

On behalf of our client,
Jyong Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated April 4, 2024 on the Company’s registration statement on Form F-1 filed
on March 7, 2024 (the “Registration Statement”). Concurrently with the submission of this letter, the Company
is filing amendment No.1 to Registration Statement (the “Amendment No.1”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.1
where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings
set forth in the Amendment No.1.

Overview, page 1

1. We note your reference to MCS-2 as your
“new botanical drug candidate developed for treatment of BPH/LUTS” and PCP as your “new botanical drug candidate developed
for the prevention of prostate cancer.” Please revise your disclosure to clarify when you initiated the development of MCS-2 and
PCP. We note that you initiated a Phase II trial for MCS-2 in 2004 and trials for PCP began as early as 2015.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 1 of the Amendment No.1.

2. Please balance your statement that you
“voluntarily” withdrew your NDA on November 30, 2022 with a discussion of the likely consequences if you had not withdrawn
your NDA given that the FDA had identified that your Phase III trial failed to show a difference between the primary efficacy endpoint
in the intent-to-treat population and the botanical drug substance used in your clinical trial, which was the basis for your NDA, was
not available. Identify all other substantive issues the FDA had conveyed regarding your NDA.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page and page 2 of the Amendment No.1.

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3. You state that the US FDA granted your
WRO meeting request. Please state if the FDA has responded to your WRO request, if so please discuss any additional information provided
by the FDA.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 2 of the Amendment No.1.

4. We note your statement that the FDA informed
you that the information you provided about API-2 was not sufficient to demonstrate comparability to API-1, “including with respect
to a statistically significant difference between MCS-2 and placebo in the primary efficacy endpoint in a clinical study.” Please
identify the clinical study indicating the statistical difference between MCS-2 and the placebo. Additionally, clarify why you would
be assessing the comparability of API-2 to API-1 on individual studies. With respect to the statement that “without new clinical
information, any NDA resubmission for MCS-2 would be at risk of the agency refusing to accept the application,” clarify whether
the additional required clinical information is with respect to the comparability of API-1 and API-2 or the efficacy of MCS-2.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 2 and page 121 of the Amendment No.1.

5. We note that your pipeline table includes
a line item for MCS-2 (API-1), which indicates that all required US testing has been completed. We also note your disclosure indicating
that the Phase III clinical trial for MCS-2 in the U.S. failed to show a difference between the treatment groups for the primary efficacy
endpoint in the intent-to-treat population. Additionally, we note that the December 5, 2023 amendment to your prior registration statement,
which was withdrawn, indicated that you had not completed all Phase III clinical trials. Please clarify how you continue to develop MCS-2
(API-1) without conducting additional clinical trials given that one of your trials failed to show efficacy and why you previously indicated
you had not completed Phase III trials and now indicated you have completed Phase III trials.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 3 and page 107 of the Amendment No.1.

6. With respect to the MCS-2 (API-2) line
item in your pipeline table, you indicate that you have completed Phase I and Phase II trials even though the FDA considers MCS-2 (API-
2) a new drug development program, and that new Phase 1 PK and Phase 3 studies are required. It is clear from your discussion beginning
on page 115 that the pharmacokinetic study described was conducted using API-1. Please include a discussion of the pharmacokinetic study
conducted using API-2 or revise your table to clarify that it has not been completed. Additionally, clarify your basis for indicating
that your Phase II trials have been completed for MCS-2 (API-2).

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 3 and page 107 of the Amendment No.1.

7. Given that API-1 is currently unavailable
and that MCS-2 (API-2) appears to be designed to treat the same indication in the same population, please clarify whether you still intend
to continue to develop MCS-2 (API-1). If you do not, please remove the separate line item from your pipeline table.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 4 and Page 108 of the Amendment No.1.

8. Your pipeline table here and on page 106
includes a drug candidate MCS-2 (API-2) for the indication of PK. Please explain if this is a different candidate than the MCS-2 (API-2)
for the indication of BPH-LUTS identified above. If not, please remove such candidate from your pipeline table.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 3 and page 107 of the Amendment No.1.

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    2

9. Please explain the significance of retaining
your NDA application number in the event you resubmit your NDA.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 4 and page 108 of the Amendment No.1.

10. You state that “the US FDA also identified
the fact that API-1, the botanical drug substance used in [y]our clinical trials and that was the basis for [y]our NDA, was not available.”
Please also discuss here, and wherever else applicable, that the supplier of API-1 withdrew its consent for you to reference their Drug
Master File on file with the FDA as you do on page 125.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 4 and page 108 of the Amendment No.1.

11. We note your statement that you have identified
an additional source for the botanical drug substance API-2. Please clarify whether you must perform studies demonstrating that the sources
of API-2 are sufficiently similar botanical drug substances.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 3, page 4 and page 108 of the Amendment No.1.

Our Strengths, page 5

12. Please provide balance to your summary
by providing a discussion of your weaknesses immediately following the discussion of your strengths.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 7 of the Amendment No.1.

Market and Industry Data, page 8

13. We note that you have not independently
verified the accuracy or completeness of the data contained in industry reports relied on in preparing your disclosure. Please note that
it is not appropriate to disclaim liability for information included in your registration statement, please revise your disclosure accordingly.
Similarly, delete the statement on page 99 that neither you nor any other party involved in this offering makes any representation as
to the accuracy or completeness of the information and data presented in the industry overview. While you may caution viewers about forward-looking
statements, much of the information included in the Industry Overview is prior or current information. Please revise your disclosure
accordingly.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 11 and page 100 of the Amendment No.1.

If clinical trials of our key drug candidates
fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities..., page 21

14. Your risk factor discussion is written
as if this is a hypothetical despite the fact that the US FDA concluded that one of your Phase III trials failed to demonstrate a statistically
significant difference between MCS-2 with API-1 and placebo in the primary efficacy endpoint in the MCS-2-US-a study. Please revise the
discussion to discuss the consequences of the FDA’s determination in terms of the additional work and expense that is now required and
the time required to complete this work.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 24 of the Amendment No.1.

The incidence and prevalence for target populations
of our drug candidates are based on estimates and third party sources..., page 29

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    3

15. We note your disclosure that your market
size information is subject to a high degree of uncertainty and risk due to a variety of factors discussed in the prospectus. Please
tell us where these factors are discussed.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 31 of the Amendment No.1.

Certain of our facilities were mortgaged.
If the mortgagees enforce the mortgage, our business could be materially and adversely impacted., page 37

16. We note your statement, “In case
the mortgagees enforce the mortgage, we may not be able to continue using our properties.” Please clarify whether you are current
on mortgages secured by your properties and if there are circumstances under which the mortgagee can require immediate repayment or foreclose
on the mortgaged properties. Disclose the activities that you conduct at these properties. Also, please file the mortgage agreements
as exhibits or tell us why you believe they are not required to be filed as exhibits.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 40 of the Amendment No.1.

We rely on third parties to supply the drug
raw materials for our developing and manufacturing activities..., page 52

17. Please expand the last paragraph of this
risk factor discussion to more specifically describe the potential consequences of a potential shortage of raw materials, including API-2,
such as the need to find an alternative botanical drug substance and perform more clinical trials if you are unable to demonstrate that
the alternative botanical drug substance is sufficiently comparable to API-2.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 55 and page 56 of the Amendment No.1.

Use of Proceeds, page 71

18. Please provide the approximate dollar
amount intended to be used for each purpose listed and indicate how far in the development process you expect to progress with the proceeds
from this offering. To the extent you are planning to develop MCS-2 using both API-1 and API-2, please separately indicate the proceeds
you plan to allocate to developing these programs. Please note that if any material amounts of other funds are necessary to accomplish
the specified purposes, state the amounts of such other funds needed for such specified purpose and the sources thereof. See Instruction
3 to Item 504 of Regulation S- K.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 74 of the Amendment No.1.

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Industry Overview

Benign Prostatic Hyperplasia, page 100

19. We note your table comparing commonly
used BPH drugs and MCS-2. Specifically, we note that you refer to MCS-2 being in the Phase III clinical trial stage. Given that you have
yet to perform clinical trials for MCS-2 (API-2), please clarify that this information is with respect to MCS-2 (API-1) and clarify your
future plans with respect to MCS-2 (API-1).

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 101 and page 102 of the Amendment No.1.

Integrate in-house capabilities that well
position us for pharmaceutical innovation..., page 109

20. Your statement that “the full integration
of these functionalities allows us to bring our drug candidates efficiently from bench to bedside, which enables us to identify and address
potential clinical, manufacturing and commercial opportunities as well as issues early in the development process, so we can direct our
efforts towards drugs with the best potential to become clinically active, cost-effective and commercially viable drugs,” appears
premature and speculative given that, at this point, none of your drug candidates have received regulatory approval. Please revise our
disclosure accordingly.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 111 of the Amendment No.1.

21. Please delete your statement that you
have “outstanding clinical results” for our innovative drug candidates. You should provide a discussion of your clinical trials
and the trial observations without a indicating whether the results demonstrate efficacy.

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 111 of the Amendment No.1.

Our Strategies

Leverage differentiated approaches to advance
our development..., page 111

22. You make several assertions regarding
the safety and efficacy of your product candidates MCS-2 and PCP. Safety and efficacy determinations are solely within the authority
of the FDA or applicable foreign regulator. You may present clinical trial end points and objective data resulting from trials without
concluding efficacy and you may state that your product candidate is well tolerated, if accurate. Please revise or remove statements/inferences
throughout your prospectus that your product candidate is safe and/or effective. For instance, and without limitation, we note the following
statements about your drug candidates:

“promising safety results observed
in Phase II clinical trials of PCP[●]” (pg. 111)midazolam and bupropion was generally safe...” (pg. 115) “the
coadministration of MCS-2 with midazolam and bupropion was generally safe...” (pg. 115) “The result presented a
dose-related response.” (pg. 116) “For subjects with moderate and severe BPH/LUTS, or to say, for those with I-PSS
larger than 10 points (inclusive), taking one MCS-2 softgel (15 mg) per day helped to achieve a 16.3% and a 22.1% I-PSS decrease
after 12 weeks...” (pg. 116) “The overall results indicated that MCS-2 softgels could relieve LUTS caused by
BPH...” (pg. 116)

Response: In response to the Staff’s comments,
the Company has revised the disclosure on page 112, page 117, page 118, page 122 and page 126 of th

United States securities and exchange commission logo
April 4, 2024
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F-3, No. 95, Section 1, Xintai 5th Road
Xizhi District, New Taipei City
Taiwan, 221
Re:Jyong Biotech Ltd.
Registration Statement on Form F-1
Filed March 7, 2024
File No. 333-277725
Dear Fu-Feng Kuo:
            We have reviewed your registration statement and have the following comments.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments.
Registration Statement on Form F-1
Overview, page 1
1.We note your reference to MCS-2 as your "new botanical drug candidate developed for
treatment of BPH/LUTS" and PCP as your "new botanical drug candidate developed for
the prevention of prostate cancer." Please revise your disclosure to clarify when you
initiated the development of MCS-2 and PCP. We note that you initiated a Phase II trial
for MCS-2 in 2004 and trials for PCP began as early as 2015.
2.Please balance your statement that you "voluntarily" withdrew your NDA on November
30, 2022 with a discussion of the likely consequences if you had not withdrawn your
NDA given that the FDA had identified that your Phase III trial failed to show a
difference between the primary efficacy endpoint in the intent-to-treat population and the
botanical drug substance used in your clinical trial, which was the basis for your NDA,
was not available. Identify all other substantive issues the FDA had conveyed regarding

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 April 4, 2024 Page 2
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
April 4, 2024
Page 2
your NDA.
3.You state that the US FDA granted your WRO meeting request. Please state if the FDA
has responded to your WRO request, if so please discuss any additional information
provided by the FDA.
4.We note your statement that the FDA informed you that the information you provided
about API-2 was not sufficient to demonstrate comparability to API-1, "including with
respect to a statistically significant difference between MCS-2 and placebo in the primary
efficacy endpoint in a clinical study." Please identify the clinical study indicating the
statistical difference between MCS-2 and the placebo. Additionally, clarify why you
would be assessing the comparability of API-2 to API-1 on individual studies. With
respect to the statement that "without new clinical information, any NDA resubmission for
MCS-2 would be at risk of the agency refusing to accept the application," clarify whether
the additional required clinical information is with respect to the comparability of API-1
and API-2 or the efficacy of MCS-2.
5.We note that your pipeline table includes a line item for MCS-2 (API-1), which indicates
that all required US testing has been completed. We also note your disclosure indicating
that the Phase III clinical trial for MCS-2 in the U.S. failed to show a difference between
the treatment groups for the primary efficacy endpoint in the intent-to-treat population.
Additionally, we note that the December 5, 2023 amendment to your prior registration
statement, which was withdrawn, indicated that you had not completed all Phase III
clinical trials. Please clarify how you continue to develop MCS-2 (API-1) without
conducting additional clinical trials given that one of your trials failed to show efficacy
and why you previously indicated you had not completed Phase III trials and now
indicated you have completed Phase III trials.
6.With respect to the MCS-2 (API-2) line item in your pipeline table, you indicate that you
have completed Phase I and Phase II trials even though the FDA considers MCS-2 (API-
2) a new drug development program, and that new Phase 1 PK and Phase 3 studies are
required. It is clear from your discussion beginning on page 115 that the pharmacokinetic
study described was conducted using API-1. Please include a discussion of the
pharmacokinetic study conducted using API-2 or revise your table to clarify that it has not
been completed. Additionally, clarify your basis for indicating that your Phase II trials
have been completed for MCS-2 (API-2).
7.Given that API-1 is currently unavailable and that MCS-2 (API-2) appears to be designed
to treat the same indication in the same population, please clarify whether you still intend
to continue to develop MCS-2 (API-1). If you do not, please remove the separate line item
from your pipeline table.
8.Your pipeline table here and on page 106 includes a drug candidate MCS-2 (API-2) for
the indication of PK. Please explain if this is a different candidate than the MCS-2 (API-2)
for the indication of BPH-LUTS identified above. If not, please remove such candidate
from your pipeline table.

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 April 4, 2024 Page 3
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
April 4, 2024
Page 3
9.Please explain the significance of retaining your NDA application number in the event
you resubmit your NDA.
10.You state that "the US FDA also identified the fact that API-1, the botanical drug
substance used in [y]our clinical trials and that was the basis for [y]our NDA, was not
available." Please also discuss here, and wherever else applicable, that the supplier of
API-1 withdrew its consent for you to reference their Drug Master File on file with the
FDA as you do on page 125.
11.We note your statement that you have identified an additional source for the botanical
drug substance API-2. Please clarify whether you must perform studies demonstrating that
the sources of API-2 are sufficiently similar botanical drug substances.
Our Strengths, page 5
12.Please provide balance to your summary by providing a discussion of your weaknesses
immediately following the discussion of your strengths.
Market and Industry Data, page 8
13.We note that you have not independently verified the accuracy or completeness of the data
contained in industry reports relied on in preparing your disclosure. Please note that it is
not appropriate to disclaim liability for information included in your registration
statement, please revise your disclosure accordingly. Similarly, delete the statement on
page 99 that neither you nor any other party involved in this offering makes any
representation as to the accuracy or completeness of the information and data presented in
the industry overview. While you may caution viewers about forward-looking statements,
much of the information included in the Industry Overview is prior or current information.
Please revise your disclosure accordingly.
If clinical trials of our key drug candidates fail to demonstrate saety and efficacy to the
satisfaction of regulatory authorities..., page 21
14.Your risk factor discussion is written as if this is a hypothetical despite the fact that the US
FDA concluded that one of your Phase III trials failed to demonstrate a statistically
significant difference between MCS-2 with API-1 and placebo in the primary efficacy
endpoint in the MCS-2-US-a study. Please revise the discussion to discuss the
consequences of the FDA's determination in terms of the additional work and expense that
is now required and the time required to complete this work.
The incidence and prevalence for target populations of our drug candidates are based on
estimates and third party sources..., page 29
15.We note your disclosure that your market size information is subject to a high degree of
uncertainty and risk due to a variety of factors discussed in the prospectus. Please tell us
where these factors are discussed.

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 April 4, 2024 Page 4
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
April 4, 2024
Page 4
Certain of our facilities were mortgaged. If the mortgagees enforce the mortgage, our business
could be materially and adversely impacted., page 37
16.We note your statement, "In case the mortgagees enforce the mortgage, we may not be
able to continue using our properties." Please clarify whether you are current on
mortgages secured by your properties and if there are circumstances under which the
mortgagee can require immediate repayment or foreclose on the mortgaged properties.
Disclose the activities that you conduct at these properties. Also, please file the mortgage
agreements as exhibits or tell us why you believe they are not required to be filed as
exhibits.
We rely on third parties to supply the drug raw materials for our developing and manufacturing
activities..., page 52
17.Please expand the last paragraph of this risk factor discussion to more specifically
describe the potential consequences of a potential shortage of raw materials, including
API-2, such as the need to find an alternative botanical drug substance and perform more
clinical trials if you are unable to demonstrate that the alternative botanical drug substance
is sufficiently comparable to API-2.
Use of Proceeds, page 71
18.Please provide the approximate dollar amount intended to be used for each purpose listed
and indicate how far in the development process you expect to progress with the proceeds
from this offering. To the extent you are planning to develop MCS-2 using both API-1
and API-2, please separately indicate the proceeds you plan to allocate to developing these
programs. Please note that if any material amounts of other funds are necessary to
accomplish the specified purposes, state the amounts of such other funds needed for such
specified purpose and the sources thereof. See Instruction 3 to Item 504 of Regulation S-
K.
Industry Overview
Benign Prostatic Hyperplasia, page 100
19.We note your table comparing commonly used BPH drugs and MCS-2. Specifically, we
note that you refer to MCS-2 being in the Phase III clinical trial stage. Given that you
have yet to perform clinical trials for MCS-2 (API-2), please clarify that this information
is with respect to MCS-2 (API-1) and clarify your future plans with respect to MCS-2
(API-1).
Integrate in-house capabilities that well position us for pharmaceutical innovation..., page 109
20.Your statement that "the full integration of these functionalities allows us to bring our
drug candidates efficiently from bench to bedside, which enables us to identify and
address potential clinical, manufacturing and commercial opportunities as well as issues

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 April 4, 2024 Page 5
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
April 4, 2024
Page 5
early in the development process, so we can direct our efforts towards drugs with the best
potential to become clinically active, cost-effective and commercially viable drugs,"
appears premature and speculative given that, at this point, none of your drug candidates
have received regulatory approval. Please revise our disclosure accordingly.
21.Please delete your statement that you have "outstanding clinical results" for our innovative
drug candidates. You should provide a discussion of your clinical trials and the trial
observations without a indicating whether the results demonstrate efficacy.
Our Strategies
Leverage differentiated approaches to advance our development..., page 111
22.You make several assertions regarding the safety and efficacy of your product candidates
MCS-2 and PCP. Safety and efficacy determinations are solely within the authority of the
FDA or applicable foreign regulator. You may present clinical trial end points and
objective data resulting from trials without concluding efficacy and you may state that
your product candidate is well tolerated, if accurate. Please revise or remove
statements/inferences throughout your prospectus that your product candidate is safe
and/or effective. For instance, and without limitation, we note the following statements
about your drug candidates:
•"promising safety results observed in Phase II clinical trials of PCP[.]" (pg. 111)
•"midazolam and bupropion was generally safe..." (pg. 115)
•"the coadministration of MCS-2 with midazolam and bupropion was generally
safe..." (pg. 115)
•"The result presented a dose-related response." (pg. 116)
•"For subjects with moderate and severe BPH/LUTS, or to say, for those with I-PSS
larger than 10 points (inclusive), taking one MCS-2 softgel (15 mg) per day helped to
achieve a 16.3% and a 22.1% I-PSS decrease after 12 weeks..." (pg. 116)
•"The overall results indicated that MCS-2 softgels could relieve LUTS caused by
BPH..." (pg. 116)
Our Drug Candidates
MCS-2
Clinical Data, page 112
23.We note that you conducted Phase I clinical studies of MCS-2 focused on
pharmacokinetics and clinical drug-drug interaction studies in the US which were
completed on April 24, 2017. Please clarify that the Phase I clinical studies conducted
where for MCS-2 using API-1 and that you will be conducting additional studies using
API-2.
Phase III Clinical Studies, page 117
24.Please clarify that the results presented are for your Phase III trials MCS-2 (API-
1). Additionally, clarify whether your proposed trial plans for Phase 1 PK and Phase 3

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 Comapany NameJyong Biotech Ltd.
 April 4, 2024 Page 6
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
April 4, 2024
Page 6
have been approved by the FDA.
25.You state that for your Phase III clinical trials "[t]he overall results indicated that MCS-2
softgels could relieve LUTS caused by BPH and had excellent tolerability." You also state
on page 106, and throughout your filing, that "[y]our pivotal Phase III clinical trial for
MCS-2 in the U.S. failed to show the difference between treatment groups for the primary
efficacy endpoint in the intent-to-treat population." Please explain this inconsistency.
26.We note your discussion of your Phase III trials. Please state the trial completion date,
disclose the trial endpoint(s), and include a discussion of results including adverse events
and serious adverse events, if any. Further, please clarify if the Phase III trials
were powered for statistical significance. If so, please provide p-values for the results of
the trial.
Suppliers, page 125
27.You state that you do not consider any of your suppliers to be material to your business
and that you can select other suppliers in the market to replace current ones at your sole
discretion. You also state that your API-1 supplier withdrew their consent for you to
reference their Drug Master File on file with the FDA which caused you to withdraw your
NDA, identify an additional source for your botanical drug substance (API-2), and
conduct additional clinical studies using the new source API-2. Please explain how your
API supplier is not considered material to your business given your inability to obtain
API-1, the challenges in demonstrating that API-1 and API-2 are sufficiently comparable,
and your risk factor discussion indicating that the quality control of botanical drug
products is very complex due to the variability of raw materials. To the extent you have a
supply agreement with the supplier of API-2, file it as an exhibit to your registration
statement. Alternatively, explain why you believe it is not required to be filed.
Consolidated financial statements
Consolidated balance sheets, page F-28
28.Please clarify why you classify part of your Bank loans as Long-term liabilities given your
statements on pages 4 and 34 that "loans from banks of approximately US$7.8 million ...
will be due within the next twelve months."
Notes to consolidated financial statements
18. Subsequent events, page F-52
29.Please revise your disclosure to address the subsequent legal developments surrounding
your failure to initi

CORRESP
1
filename1.htm

    DLA Piper UK LLP Beijing Representative Office

    20th Floor, South Tower, Beijing Kerry Center

    1 Guanghua Road, Chaoyang District

    Beijing 100020, China

T +86 10 8520 0600

    F +86 10 8520 0700

    W www.dlapiper.com

December 5, 2023

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

Mary Mast

Doris Stacey Gama

Joe McCann

    Re:
    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Amendment No. 1 to the Registration Statement on Form F-1

    Filed on October 18, 2023 (File No. 333-274042)

Dear Sir and Madam:

On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated September 14, 2023 and the Staff’s oral comments in the call on November
13, 2023 on the Company’s amendment No.1 to registration statement on Form F-1 filed on October 18, 2023 (the “Amendment
No.1”). Concurrently with the submission of this letter, the Company is filing amendment No.2 to Registration Statement
(the “Amendment No.2”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.2
where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings
set forth in the Amendment No.2.

Prospectus Summary

Overview, page 1

    1.
    On September 13, 2023 we delivered oral comments
    to be addressed in your filing. Given that the comments were not adequately addressed, we are reissuing the comments. We will be
    issuing additional oral comments in our call on November 13, 2023. In your next amendment, please address all oral comments.

In response to the Staff’s comments, the Company has revised the disclosure in the Amendment No.2 on pages 1, 2, 30, 67, 76, 77,
96, 100, 101, 105, 111, 112, 114 and 121 in accordance with the Staff’s instructions.

    2.
    Please revise your discussion to remove
all statements of safety and efficacy. Statements indicating or implying safety and/or efficacy are within the sole authority of the
FDA or equivalent foreign regulator. Such statements include, but are not limited to the following:

    ●
    The pooled study results of our phase III clinical trials on MCS-2 show that the primary endpoint has reached statistical significance and exhibited safety profile.

    ●

    MCS-2 has a powerful antioxidant capacity and can reduce inflammatory
cytokines. It takes effect by reducing oxidative stress and inflammation and has a dose responsive effect.

You may describe the objective results
of your clinical trials, including the changes in IPSS scores experienced by participants in your trials, the p values of any statistical
analyses performed and the lack of any serious adverse events. You may not indicate that the results indicate that your product candidate
is effective and/or safe.

In response to the Staff’s comments,
the Company has globally revised the statements of safety and efficacy in the Amendment No.2 in accordance with the Staff’s instructions.

    3.
    We note your response to our prior comment 2 stating
    that the active constituents in MCS- 2 are carotenoids. Please also identify the specific carotenoids.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.2 on pages 1, 76, 100 in accordance with the Staff’s instructions.

    4.
    We note your response to our prior comment 6 and
    your disclosure on page 98. Please also include more prominent disclosure in the Summary and Risk Factor sections conveying the challenges
    of developing a botanical drug and how rare it is to obtain FDA approval. Your disclosure should including the number of botanical
    drugs that have received FDA approval and when the most recent one was approved. Your risk factor should discuss the fact that quality
    control of botanical drugs is more complex due to the variability of botanical raw materials, ensuring such consistency presents
    a scientific and regulatory challenge for any company developing a botanical drug and any specific challenges you have encountered.

In response to the Staff’s comments, the Company has revised the disclosure in the Amendment No.2 on pages 3, 7, 13, 14, and 99
in accordance with the Staff’s instructions.

Risk Factors, page 10

    5.
    Include a risk factor discussing your going concern
    opinion, your outstanding debt and annual debt service obligations. To the extent that you intend to use proceeds from the offering
    to make debt service payments, please disclose this information here and in your Use of Proceeds section.

In response to the Staff’s
comments, the Company has revised the disclosure in the Amendment No.2 on pages 30, 42, 43 and 67 in accordance with the
Staff’s instructions.

We have been involving in legal proceedings..., page 28

    6.
    We note your response to our previous comment 5
    specifically regarding your appeal to the court’s recent judgement in favor of the plaintiff ordering you to pay RMB12.0 million
    plus interest and expenses and your disclosure on page 82 stating that you would need additional resources to pay the settlement
    in the future. Please discuss how the company plans to pay the settlement if the judgement is not overturned. To the extent you would
    use proceeds from the offering to pay any settlements, please include disclosure to this effect and update your Use of Proceeds section.

In response to the Staff’s comments, the Company has revised the disclosure in the Amendment No.2 on pages 30, 42, 43 and 67 in
accordance with the Staff’s instructions.

    2

We rely on third parties to supply the drug raw materials for
our developing and manufacturing activities..., page 48

    7.
    We note your statement that your drug raw materials
    are supplied by multi-source suppliers. Given that comparability is a critical issue for botanical drugs and you are performing additional
    tests related to assessing the comparability of API-1 and API-2, revise your disclosure to clarify that you performed your clinical
    trials of MCS-2 manufactured with API-1 and discuss the potential consequences if API-2 is determined to not be comparable.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.2 on page 49 in accordance with the Staff’s instructions.

Use of Proceeds, page 66

    8.
    Clarify the stage of the development process you
    expect to achieve for each of your product candidates with the proceeds from this offering.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.2 on page 67 in accordance with the Staff’s instructions.

General and Administrative Expenses, page 80

    9.
    We note your disclosure indicating that you expect
    costs to increase when you become a public company and your NDA “for new drug candidate, MCS-2, is approved by the US FDA.”
    It is not appropriate to assume or predicted that your product candidate will be approved. Please revise your disclosure accordingly.
    Similarly, revise page 82.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.2 on pages 81 and 83 in accordance with the Staff’s instructions.

Overall summary and conclusions, page 109

    10.
    Please delete the statement that the phase II clinical
    studies of MCS-2 indicated favorable data to support its efficacy in improving BPH/LUTS. This determination is in the sole authority
    of the FDA or equivalent foreign regulator. Please limit your disclosure to your objective observations.

In response to the Staff’s comments,
the Company has deleted the statement in the Amendment No.2 on page 110 in accordance with the Staff’s instructions.

If you have any questions
regarding the Amendment No.2, please contact the undersigned by phone at (+86) 10 8520 0616 or via e-mail at yang.ge@dlapiper.com.

    Very truly yours,

    /s/ Yang Ge

    Yang Ge

    cc:
    Yang Ge

3

United States securities and exchange commission logo
November 9, 2023
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F, No. 95, Section 1, Xintai 5th Road,
Xizhi District, New Taipei City,
Taiwan, 221
Jyong Biotech Ltd.
Re:Jyong Biotech Ltd.
Amended Registration Statement on Form F-1
Filed October 18, 2023
File No. 333-274042
Dear Fu-Feng Kuo:
            We have reviewed your amended registration statement and have the following
comment(s).
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our September 14, 2023 letter.
Amendment No. 1 to Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.On September 13, 2023 we delivered oral comments to be addressed in your filing.  Given
that the comments were not adequately addressed, we are reissuing the comments. We
will be issuing additional oral comments in our call on November 13, 2023.  In your next
amendment, please address all oral comments.
2.Please revise your discussion to remove all statements of safety and efficacy.  Statements
indicating or implying safety and/or efficacy are within the sole authority of the FDA or
equivalent foreign regulator.  Such statements include, but are not limited to the

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 November 9, 2023 Page 2
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
November 9, 2023
Page 2
following:

•The pooled study results of our phase III clinical trials on MCS-2 show that the
primary endpoint ...has reached statistical significance and exhibited safety safety
profile.
•MCS-2 has a powerful antioxidant capacity and can reduce inflammatory cytokines.
It takes effect by reducing oxidative stress and inflammation and has a dose-
responsive effect.

You may describe the objective results of your clinical trials, including the changes in I-
PSS scores experienced by participants in your trials, the p values of any statistical
analyses performed and the lack of any serious adverse events.  You may not indicate that
the results indicate that your product candidate is effective and/or safe.

3.We note your response to our prior comment 2 stating that the active constituents in MCS-
2 are carotenoids. Please also identify the specific carotenoids.
4.We note your response to our prior comment 6 and your disclosure on page 98. Please
also include more prominent disclosure in the Summary and Risk Factor sections
conveying the challenges of developing a botanical drug and how rare it is to obtain FDA
approval. Your disclosure should including the number of botanical drugs that have
received FDA approval and when the most recent one was approved.  Your risk factor
should discuss the fact that quality control of botanical drugs is more complex due to the
variability of botanical raw materials, ensuring such consistency presents a scientific and
regulatory challenge for any company developing a botanical drug and any specific
challenges you have encountered.
Risk Factors, page 10
5.Include a risk factor discussing your going concern opinion, your outstanding debt and
annual debt service obligations.  To the extent that you intend to use proceeds from the
offering to make debt service payments, please disclose this information here and in your
Use of Proceeds section.
We have been involving in legal proceedings..., page 28
6.We note your response to our previous comment 5 specifically regarding your appeal to
the court's recent judgement in favor of the plaintiff ordering you to pay RMB12.0 million
plus interest and expenses and your disclosure on page 82 stating that you
would need additional resources to pay the settlement in the future. Please discuss how the
company plans to pay the settlement if the judgement is not overturned. To the extent you
would use proceeds from the offering to pay any settlements, please include disclosure to
this effect and update your Use of Proceedssection.

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 November 9, 2023 Page 3
 FirstName LastName
Fu-Feng Kuo
Jyong Biotech Ltd.
November 9, 2023
Page 3
We rely on third parties to supply the drug raw materials for our developing and manufacturing
activities..., page 48
7.We note your statement that your drug raw materials are supplied by multi-source
suppliers.  Given that comparability is a critical issue for botanical drugs and you are
performing additional tests related to assessing the comparability of API-1 and API-2,
revise your disclosure to clarify that you performed your clinical trials of MCS-2
manufactured with API-1 and discuss the potential consequences if API-2 is determined to
not be comparable.
Use of Proceeds, page 66
8.Clarify the stage of the development process you expect to achieve for each of your
product candidates with the proceeds from this offering.
General and Administrative Expenses, page 80
9.We note your disclosure indicating that you expect costs to increase when you become a
public company and your NDA "for new drug candidate, MCS-2, is approved by the US
FDA."  It is not appropriate to assume or predicted that your product candidate will be
approved.  Please revise your disclosure accordingly.  Similarly, revise page 82.
Overall summary and conclusions, page 109
10.Please delete the statement that the phase II clinical studies of MCS-2 indicated favorable
data to support its efficacy in improving BPH/LUTS.  This determination is in the sole
authority of the FDA or equivalent foreign regulator.  Please limit your disclosure to your
objective observations.
            Please contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 if you have
questions regarding comments on the financial statements and related matters. Please contact
Doris Stacey Gama at 202-551-3188, Joseph McCann at 202-551-6262 or Suzanne Hayes at 202-
551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Yang Ge

CORRESP
1
filename1.htm

    DLA Piper UK LLP Beijing Representative Office

    20th Floor, South Tower, Beijing Kerry Center

    1 Guanghua Road, Chaoyang District

    Beijing 100020, China

    T +86 10 8520 0600

    F +86 10 8520 0700

    W www.dlapiper.com

October 18, 2023

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

Mary Mast

Doris Stacey Gama

Joe McCann

    Re:

    Jyong Biotech Ltd.

    Response to the Staff’s Comments on

    Amendment No. 1 to the Registration Statement on Form F-1

    Filed on August 17, 2023 (File No. 333-274042)

Dear Sir and Madam:

On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated September 14, 2023 on the Company’s registration statement on Form F-1
filed on August 17, 2023 (the “Registration Statement”). Concurrently with the submission of this letter, the
Company is filing amendment No.1 to Registration Statement (the “Amendment No.1”) via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.1 where
the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth
in the Amendment No.1.

Prospectus Summary

Overview, page 1

    1.
    We note your response to prior comment 1. Please revise the Summary to explain briefly the term “carotenoid” in order to provide context for your use of the term “carotenoid chylomicrons.”

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on pages 1, 2, 75 and 99 in accordance with the Staff’s instructions.

    2.
    We note your revised disclosure in response to prior comment 2. Please revise to identify the active constituents in your lead botanical drug candidate, MCS-2. Similarly, disclose the active constituents contained in your other clinical stage botanical drug candidate, PCP, which is “essentially the same in terms of composition of active ingredients” as MCS-2.

In response to the Staff’s
comments, the Company has revised the disclosure in the Amendment No.1 on pages 1, 2, 75, 76, 99 and 100 in accordance with the
Staff’s instructions.

    3.
    We note your disclosures here and elsewhere indicating that you have “patented active pharmaceutical ingredients.” Please revise to clarify, if true, that your patents cover certain compositions of carotenoids and chylomicrons.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 122 in accordance with the Staff’s instructions.

    4.
    We note your revised disclosure on page 2 in response to prior comment 2. Regarding your submission of comparative data of API-1 and API-2 for U.S. FDA’s review, please disclose the feedback, if any, that FDA provided to you concerning this submission.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 2 in accordance with the Staff’s instructions.

We have been involving in legal proceedings in the ordinary course
of our business..., page 28

    5.
    We note your revised disclosure in the first paragraph indicating that the lawsuit, if not settled, is likely to result in an outcome unfavorable to you. With reference to your disclosure on page F-27, please discuss the financial impact of the lawsuit. To the extent that you presently do not have resources available to pay the settlement or judgment, please revise your liquidity and capital resources discussion accordingly.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on pages 28, 30, 82, 124 and 125 in accordance with the Staff’s
instructions.

Botanicals are favored, page 95

    6.
    With a view to disclosure, please tell us how many botanical drug products to date have received FDA approval. To the extent that only a limited number of botanical drug products are FDA approved, please revise this section to disclose this information and similarly highlight this information in the Summary to convey the novelty and/or challenges of receiving approval for a botanical drug.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 98 in accordance with the Staff’s instructions.

Suppliers, page 117

    7.
    Please revise to explain whether you use one or more suppliers for API-1. Provide the same information for API-2. Also discuss the types of raw materials that you source from suppliers. For instance, please discuss whether your suppliers provide you with whole plants and/or with certain carotenoids or chylomicrons.

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on pages 2 and 120 in accordance with the Staff’s instructions.

Regulations, page 123

    8.
    Please revise your discussion of FDA Regulation and Product Approval to address regulatory issues and technical challenges that are unique to botanical drug products as compared to nonbotanical drugs. In this regard, we refer to the information contained in FDA’s “Botanical Drug Development: Guidance for Industry” available at: https://www.fda.gov/files/drugs/published/Botanical-Drug-Development--Guidance-for-Industry.pdf

In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 127 in accordance with the Staff’s instructions.

If you have any questions
regarding the Amendment No.1, please contact the undersigned by phone at (+86) 10 8520 0616 or via e-mail at yang.ge@dlapiper.com.

    Very truly yours,

    /s/ Yang Ge

    Yang
Ge

    cc:
    Yang Ge

United States securities and exchange commission logo
September 14, 2023
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F, No. 95, Section 1, Xintai 5th Road,
Xizhi District, New Taipei City,
Taiwan, 221
Re:Jyong Biotech Ltd.
Registration Statement on Form F-1
Filed August 17, 2023
File No. 333-274042
Dear Fu-Feng Kuo:
            We have reviewed your registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.We note your response to prior comment 1. Please revise the Summary to explain briefly
the term “carotenoid” in order to provide context for your use of the term “carotenoid
chylomicrons.”
2.We note your revised disclosure in response to prior comment 2. Please revise to identify
the active constituents in your lead botanical drug candidate, MCS-2. Similarly, disclose
the active constituents contained in your other clinical stage botanical drug candidate,
PCP, which is “essentially the same in terms of composition of active ingredients” as

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MCS-2.
3.We note your disclosures here and elsewhere indicating that you have “patented active
pharmaceutical ingredients.”  Please revise to clarify, if true, that your patents cover
certain compositions of carotenoids and chylomicrons.
4.We note your revised disclosure on page 2 in response to prior comment 2. Regarding
your submission of comparative data of API-1 and API-2 for U.S. FDA’s review, please
disclose the feedback, if any, that FDA provided to you concerning this submission.
We have been involving in legal proceedings in the ordinary course of our business..., page 28
5.We note your revised disclosure in the first paragraph indicating that the lawsuit, if not
settled, is likely to result in an outcome unfavorable to you.  With reference to your
disclosure on page F-27, please discuss the financial impact of the lawsuit.  To the extent
that you presently do not have resources available to pay the settlement or judgment,
please revise your liquidity and capital resources discussion accordingly.
Botanicals are favored, page 95
6.With a view to disclosure, please tell us how many botanical drug products to date have
received FDA approval.  To the extent that only a limited number of botanical drug
products are FDA approved, please revise this section to disclose this information and
similarly highlight this information in the Summary to convey the novelty and/or
challenges of receiving approval for a botanical drug.
Suppliers, page 117
7.Please revise to explain whether you use one or more suppliers for API-1. Provide the
same information for API-2. Also discuss the types of raw materials that you source from
suppliers. For instance, please discuss whether your suppliers provide you with whole
plants and/or with certain carotenoids or chylomicrons.
Regulations, page 123
8.Please revise your discussion of FDA Regulation and Product Approval to address
regulatory issues and technical challenges that are unique to botanical drug products as
compared to nonbotanical drugs. In this regard, we refer to the information contained in
FDA’s “Botanical Drug Development: Guidance for Industry” available at:
https://www.fda.gov/files/drugs/published/Botanical-Drug-Development--Guidance-for-
Industry.pdf

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September 14, 2023
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            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            You may contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Yang Ge

CORRESP
1
filename1.htm

    DLA Piper UK LLP Beijing Representative Office

    20th Floor, South Tower, Beijing Kerry Center

    1 Guanghua Road, Chaoyang District

    Beijing 100020, China

    T +86 10 8520 0600

    F +86 10 8520 0700

    W www.dlapiper.com

August 17, 2023

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

Washington, D.C. 20549

    Attn.:
    Ibolya Ignat

    Mary Mast

    Doris Stacey Gama

    Joe McCann

 Re: Jyong Biotech Ltd.

Response to the Staff’s Comments on Amendment No. 2 to Draft Registration Statement on Form F-1 Submitted July 5, 2023 with CIK
No. 0001954488

Dear Sir and Madam:

On behalf of our client,
Jyong Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses to
the comments contained in the Staff’s letter dated July 21, 2023 on the Company’s Draft Registration Statement on Form F-1
previously submitted on July 5, 2023 (the “Second Revised Draft Registration Statement”).

Concurrently with the
submission of this letter, the Company is filing its registration statement on Form F-1 (the “Registration Statement”)
and certain exhibits via EDGAR to the Commission.

The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Registration Statement
where the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings
set forth in the Registration Statement.

Prospectus Summary

Overview, page 1

    1.
    We note your response to prior comment 2. Please:

 ● Revise the Summary to explain briefly the terms “carotenoid”
and “chylomicron” in order to provide context for your use of the term “carotenoid chylomicrons.”

 ● Revise the Business section to identify clearly the active
pharmaceutical ingredients and tell us whether all active ingredients are “plant-derived.” In this regard, it is unclear
whether “PL, PF, PE, TC and BC” are active ingredients or biomarkers, and whether these are two-letter abbreviations used
in the scientific community to represent a specific carotenoid, chylomicron, or something else.

In response to the Staff’s comments,
the Company has revised the disclosure in the Registration Statement on pages 1, 2, 75, 96 and 104 in accordance with the Staff’s instructions.

    2.
    We note your response to prior comment 3. Please
    revise the prospectus to disclose the information provided in your response. In addition, please identify AP-1 and AP-2, or advise.
    With regard to the third sentence, explain to us how two different ingredients can have the same composition.

In response to the Staff’s
comments, the Company has revised the disclosure in the Registration Statement on page 2 in accordance with the Staff’s
instructions.

Benign Prostatic Hyperplasia, page 91

    3.
    We note your revised disclosure on page 92 in response
    to prior comment 6. Regarding FDA Approval status of MCS-2, please revise the language so that it does not imply that FDA approval
    is forthcoming.

In response to the Staff’s comments,
the Company has revised the disclosure in the Registration Statement on page 92 in accordance with the Staff’s instructions.

Overall summary and conclusions, page 105

    4.
    We note your response to our prior comment 11 regarding
    having to conduct additional Phase I studies per FDA requirements. Please disclose why the FDA required additional Phase I studies.

In response to the Staff’s comments,
the Company has revised the disclosure in the Registration Statement on page 105 in accordance with the Staff’s instructions.

If you have any questions
regarding the Registration Statement, please contact the undersigned by phone at (+86) 10 8520 0616 or via e-mail at yang.ge@dlapiper.com.

    Very truly yours,

    /s/ Yang Ge

    Yang
Ge

cc: Yang Ge

United States securities and exchange commission logo
July 21, 2023
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F, No. 95, Section 1, Xintai 5th Road,
Xizhi District, New Taipei City,
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 2 to Draft Registration Statement on Form F-1
Submitted July 5, 2023
CIK No. 0001954488
Dear Fu-Feng Kuo:
            We have reviewed your amended draft registration statement and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 2 to Draft Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.We note your response to prior comment 2. Please:
•Revise the Summary to explain briefly the terms “carotenoid” and “chylomicron” in
order to provide context for your use of the term “carotenoid chylomicrons.”
•Revise the Business section to identify clearly the active pharmaceutical ingredients
and tell us whether all active ingredients are “plant-derived.” In this regard, it is
unclear whether “PL, PF, PE, TC and BC” are active ingredients or biomarkers, and
whether these are two-letter abbreviations used in the scientific community to

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represent a specific carotenoid, chylomicron, or something else.
2.We note your response to prior comment 3. Please revise the prospectus to disclose the
information provided in your response. In addition, please identify AP-1 and AP-2, or
advise. With regard to the third sentence, explain to us how two different ingredients can
have the same composition.
Benign Prostatic Hyperplasia, page 91
3.We note your revised disclosure on page 92 in response to prior comment 6. Regarding
FDA Approval status of MCS-2, please revise the language so that it does not imply that
FDA approval is forthcoming.
Overall summary and conclusions, page 105
4.We note your response to our prior comment 11 regarding having to conduct additional
Phase I studies per FDA requirements. Please disclose why the FDA required additional
Phase I studies.
            You may contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Yang Ge

United States securities and exchange commission logo
June 9, 2023
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F, No. 95, Section 1, Xintai 5th Road,
Xizhi District, New Taipei City,
Taiwan, 221
Re:Jyong Biotech Ltd.
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted May 22, 2023
CIK No. 0001954488
Dear Fu-Feng Kuo:
            We have reviewed your amended draft registration statement and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form F-1
Prospectus Summary
Overview, page 2
1.We note your response to prior comment 4 indicating that your two leading drug
candidates MCS-2 and PCP contain the same “drug substances.” Please revise to disclose
this point. Recognizing that you are targeting two different indications and utilizing two
different drug names, revise to explain whether and, if so how MCS-2 and PCP differ in
terms of composition. For instance, and with reference to your disclosure on page 52,
explain whether they contain the same or different active ingredients, dosage form,
strength and/or route of administration. To the extent that differences exist, please explain

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whether FDA has indicated its agreement that the same Phase 1 safety data can be used
for purposes of approving MCS-2 and PCP.
2.We refer to prior comment 17 and note your revised disclosure in the Overview section
indicating that MCS-2 and PCP are “patented pharmaceutical composition of carotenoids”
and that they are “plant-based.” Please revise to identify the active pharmaceutical
ingredient(s) contained in these candidates or advise. In this regard, we note that your
response to comment 7 references active pharmaceutical ingredient(s) and your clinical
trial disclosures on pages 103 and 110 discuss measurement of unidentified “active
ingredients.”
3.With reference to your response to prior comment 7, please revise your Summary
presentation and pipeline table to highlight that your NDA application for your lead
candidate MCS-2 is not complete. Clarify the reason(s) why you must submit additional
data to FDA and your plan to submit this related data in 2024. Explain the work you must
complete in order to prepare this submission. In this regard, please identify the active
pharmaceutical ingredient (API) that was in short supply due to COVID-19 and clarify
whether you need to conduct additional/new clinical trials using the API contained in
MCS-2 or present data to FDA showing that the replacement API should be deemed a
valid replacement for purposes of FDA approval. As applicable, discuss feedback received
from FDA on the status of the application and the related data you must submit.
4.We note your response to our previous comment 6. Please revise the Summary to explain
the meaning of the term "bespoke development strategies." With reference to your revised
disclosure on page 97, revise your Summary disclosure to explain the term "I-PSS" at first
use.
If we encounter delays..., page 17
5.We note your revised disclosure in response to prior comment 10. Please reconcile your
revised disclosure on page 17 with your disclosure on page 18 indicating that you have
experienced delays in the enrollment of patients in your clinical trials due to government
orders and site policies on account of the COVID-19 pandemic and the monkeypox
outbreak.
Industry Overview
Benign Prostatic Hyperplasia, page 91
6.We note your response to our previous comment 14. Please revise the table beginning on
page 91 to reflect, if true, that FDA and/or comparable regulatory bodies have approved
each of the five competitive products and that MCS-2 has not been similarly approved.
Further, in the pros section for MCS-2 please remove statement that MCS-2 has a "good
clinical safety profile" as safety determinations are solely within the authority of the FDA
or applicable foreign regulator.

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Business
Overview, page 97
7.We note your response to our previous comment 16 and reissue. You make several
assertions regarding the safety and efficacy of your product candidates MCS-2 and PCP.
Safety and efficacy determinations are solely within the authority of the FDA or
applicable foreign regulator. You may present clinical trial end points and objective data
resulting from trials without concluding efficacy and you may state that your product
candidate is well tolerated, if accurate. Please revise or remove statements/inferences
throughout your prospectus that your product candidate is safe and/or effective. For
instance, and without limitation, we note the following statements about your drug
candidates:
•"It is a new drug developed for BH/LUTS treatment with safety and efficacy." (pg.
78, 91,101)
•"MCS-2 showed safety in both short-term and long-term" (pg. 97)
•"which shew (sic) good safety profile of MCS-2." (pg. 105)
•"According to the results of phase III OLEs, MCS-2 softgels showed safety" (pg.
107)
Our Drug Candidates
Drug Candidate
MCS-2
Mechanism of Action, page 102
8.We note your response to our previous comment 5 and the inclusion of the graph on page
103. Please revise the graphic and accompanying text to explain how the graph shows that
MCS-2 has anti-inflammatory activity. In this regard, please revise to define LPS, BDS,
and the symbols used above the bar graph.
Phase I Clinical Studies
Pharmacokinetics, page 103
9.For the table on page 103 indicating the concentration of active ingredients in the serum,
please define AUC, C, t and the accompanying subscripts. Identify the active ingredients.
Clinical Data, page 104
10.We note your use of P-values and R-values on pages 104 and 106. Please explain what the
disclosed P-values and R-values indicate about statistical significance and correlation.
11.We note your response to prior comment 19 and reissue. Please revise your disclosure to
explain why your clinical trials were not conducted in sequential order and why the NDA
submission was made four years after the last clinical trial was completed.

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Clinical Drug-Drug Interaction, page 104
12.We note your response to our previous comment 23 and reissue. Please expand to discuss
bupropion and midazolam and the significance of your results in this study as well as the
clinical drug interaction study of PCP on page 110. In this regard, please clarify what
indication or indications are treated with bupropion and/or midazolam.
PCP
Anti-inflammatory Activity, page 110
13.We note the inclusion of the graph on page 110 in response to our previous comment 30.
Please amend to include a brief description of the symbols used within the graph.
Patents, page 116
14.Please revise to disclose the patent numbers for your two granted US composition of
matter patents. Tell us whether MCS-2 are PCP are covered by the same or different
composition of matter patents. Also indicate whether IC is covered by one of these two
granted patents.
Management
Directors and Executive Officers, page 151
15.Please revise to disclose the duration of Mr. Ming Tsan Hsu tenure as deputy chairman of
the board of directors at Joyear Construction Co., Ltd and supervisor of Duennien
Construction Co., Ltd.
Consolidated Financial Statements, page F-1
16.Please update your financial statements and corresponding financial information
throughout the filing to comply with Item 8.A.4 of Form 20-F.
Notes to Consolidated Financial Statements
17. Commitments and Contingencies
Litigation, page F-24
17.You disclose that the Group is not aware of any current pending legal matters or claims
except for those disclosed in this prospectus. Please revise to provide disclosure related to
the TaiZhou litigation matter pursuant to ASC 450-20-50 since the case appears to be
ongoing. Tell us also how you considered including a discussion of this matter in your
subsequent events note on page F- 24.

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            You may contact Ibolya Ignat at 202-551-3636 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Yang Ge

United States securities and exchange commission logo
April 15, 2023
Fu-Feng Kuo
Chief Executive Officer
Jyong Biotech Ltd.
23F, No. 95, Section 1, Xintai 5th Road,
Xizhi District, New Taipei City,
Taiwan, 221
Re:Jyong Biotech Ltd.
Draft Registration Statement on Form F-1
Submitted March 16, 2023
CIK No. 0001954488
Dear Fu-Feng Kuo:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.We note your disclosure that you submitted a new drug application (NDA) to FDA in
December 2021. It is not appropriate to assume that FDA will approve this NDA.
Accordingly, please revise to remove your disclosures that you are “commercial-ready”
and “near commercialization.” Similarly revise the disclosure indicating that you have
“successfully developed a series of drug candidates.”

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Page 2
2.In your pipeline table, we note that the arrows for your new drug (plant derived) IC are
drawn to the end of the pre-clinical column on page 1 and on page 97 the arrows pass the
pre-clinical stage and enter phase I. However, your disclosure in the prospectus and
business section indicates that the pre-clinical portion of the clinical trial for this new drug
is still ongoing. Please shorten the arrows in the pipeline table on page 1 and 97 to match
the current status of the IC drug.
3.Please revise the pipeline table to identify the indications for each of the three product
candidates. Also, tell us why the IC drug candidate shows both US and Taiwan given your
disclosure on page 101 that Phase 1 trials are expected to be conducted in Taiwan.
4.With a view to disclosure, please tell us whether MCS-2 and PCP are the same drug  In
this regard, we note that you appear to present the same Phase 1 data for both candidates
on pages 104 and 110.
5.We note your disclosure on pages 1-2 that MCS-2 has a powerful antioxidant capacity and
can reduce inflammatory cytokines. We also note your disclosure on page 2 that it takes
effect by reducing oxidative stress and inflammation and has a dose-
response effect. Please tell whether each of these performance claims is supported by the
disclosures presented in your Business section.
6.Please revise to explain briefly the term “I-PSS” and provide a more detailed description
in the Business section. Also, explain the term “bespoke” at first use.
7.Please revise your disclosure on page 2 to clarify the status of your NDA  We note your
disclosure that you submitted the application in December 2021; however, it is not clear if
or when FDA accepted this application.  Also, if known, explain why the application
remains pending beyond the ten-month period referenced on page 124.
Risk Factor Summary, page 7
8.We note that your summary risk factors are five pages in length. Please limit your
summary risk factors to no more than two pages that summarize the principal factors that
make an investment in the registrant or offering speculative or risky. Refer to Item 105(b)
of Regulation S-K for guidance.
Risks Related to Our Business and Industry , page 9
9.You include a risk factor summary stating that you have been involved in legal
proceedings in the ordinary course of your business. Please amend here and the header on
page 30 to clarify, if true, that you are involved in active legal proceedings.
If we encounter delays..., page 19
10.We note your disclosure that you have experienced enrollment delays. Please revise to
identify which trial or trials have been delayed and whether the delay or delays persist.

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Use of Proceeds, page 68
11.Please revise to disclose how the proceeds will be allocated across the three drug
candidates.  In this regard, we note your disclosure on page 18 that all of your key drug
candidates are still in development.
Enforcement of Civil Liabilities, page 73
12.Please provide Conyers Dill & Pearman’s consent for the disclosure concerning statutory
enforcement in the Cayman Islands.
Management's Discussion and Analysis..., page 77
13.We note disclosures on pages 77, 97 and 98 comparing the safety and efficacy of your
MCS-2 candidate to other drugs that have reached commercialization. Please note that you
do not have a basis to compare your candidate to other products or third party product
candidates unless you have conducted head to head trials. Please revise your registration
statement accordingly.
Industry Overview
Benign Prostatic Hyperplasia, page 93
14.The table on page 93 shows a comparison of the commonly used BPH drugs and MCS-2.
Please revise the table to reflect, if true, that FDA and/or comparable regulatory bodies
have approved each of the five competitive products and that MCS-2 has not been
similarly approved. Also, tell us why your table does not reflect any “typical side effects”
given the AEs reflected in your clinical trials discussion on pages 104-108. Please amend
the graph to similarly include the molecular formula for MCS-2, and identify the first line
drugs referenced in the pros section for MCS-2.
Prostate Cancer Prevention, page 94
15.Please revise to provide support for the statement that Chinese herbal medicine treatment
for prostate cancer can achieve a better therapeutic effect.
Business
Overview, page 97
16.You make several assertions regarding the safety and efficacy of your product candidates
MCS-2 and PCP. Safety and efficacy determinations are solely within the authority of the
FDA or applicable foreign regulator. You may present clinical trial end points and
objective data resulting from trials without concluding efficacy and you may state that
your product candidate is well tolerated, if accurate. Please revise or remove
statements/inferences throughout your prospectus that your product candidate is safe
and/or effective. For instance, and without limitation, we note the following statements
about your drug candidates:

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•"It is a new drug developed with clinical safety and sustained efficacy." page 1
•"Phase 1 clinical trials have indicated reliable efficacy and favorable safety profile."
page 2
•"Superior new drug candidate...with promising efficacy and safety." page 2
•"Excellent safety profile"; "can be used alone or in combination with existing first-
line drugs to produce synergistic effects."
17.We note your references on pages 97 and 98 to the presence of medical-grade active
pharmaceutical ingredients in your two lead candidates. Please revise to identify these
ingredients and/or the applicable plant.
Our Strategies, page 101
18.We note your disclosure concerning letters of intent received as of June 30, 2022 relating
to distribution and licensing rights of MCS-2.  Please update your disclosures to clarify
the current status of these offers and/or overtures.
Clinical Data, page 104
19.We note your disclosure on page 122 indicating that clinical trials are typically conducted
in sequential order beginning with a Phase 1 trial. Please revise to discuss the timing and
sequencing of your MCS-2 trials. In this regard, we note that the Phase 2 trials took place
in the 2004-2006 timeframe and your Phase 3 trials appear to have taken place in the
2009-2011 timeframe.  As such please explain why the Phase 1 trials occurred several
years later in the 2015-2017 timeframes.  Also, discuss the timing of the NDA filing
relative to when the clinical trials were completed.
20.Please disclose where the Phase 1 studies were conducted.
21.We note your disclosure describing multiple clinical trials for MCS-2 and PCP. Please
revise the disclosure to provide p-values and conclusions as to the statistical significance
of all primary and, if applicable, secondary endpoints. If no statistical analysis was
performed please disclose this point.
22.We note the references to “efficacy” and “efficacy data” in the Phase 1 discussion.  Please
tell us your basis for using these terms in presenting these Phase 1 results.  In this regard,
it is not clear that a higher concentration of the active ingredient in patient serum relates to
efficacy.  Also, tell us your basis for concluding that coadministration of MCS-2 would
not affect the efficacy of midazolam and bupropion solely based on the lack of significant
differences in the concentration levels of these two drugs.  For instance, please tell us
whether I-PSS was assessed in your clinical drug-drug interaction study.
Clinical Drug-Drug Interaction, page 104
23.You state that in the study of clinical drug-drug interaction of MCS-2 the total and peak
exposure of bupropion, midazolam, and their measured metabolites were not significantly
altered after multiple daily doses of MCS-2. Please expand to discuss bupropion and

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midazolam and the significance of your results in this study as well as the clinical drug
interaction study of PCP on page 110. In this regard, please clarify what indication or
indications are treated with bupropion and/or midazolam.
Pharmacokinetics, page 104
24.We note that you reference a figure that indicates the concentration of active ingredients
in the serum used. Please include the referenced figure or list the concentration of active
ingredients.
Phase II Clinical Studies, page 105
25.Please expand your Phase II and Phase III “Efficacy” sections to present the I-PSS data in
addition to the percentage changes that are currently disclosed.
Phase III Clinical Studies
Description of Clinical Studies, page 106
26.Please revise to clarify when these Phase III studies were conducted.  In this regard, we
note that FDA and TFDA approval dates are disclosed but the timeframes for the trials are
not clear.
Efficacy, page 107
27.Please revise to disclose the I-PSS results for the 28 patients who received between 15-30
mg/day.
Safety, page 108
28.You state that the most common adverse events reported in phase III clinical trials
were gastrointestinal disorders, infections and infestations, musculoskeletal and
connective tissue disorders, and investigations, repressing 11.7%, 7.0%, 5.7%, 5.1% of the
545 subjects, respectively. Please amend to clarify whether these adverse events are
related or unrelated to MCS-2. If unrelated, please discuss the related AE disclosed in the
Phase III Clinical Trial table on page 107.
29.Regarding the phase III OLEs, clarify whether the adverse events mentioned were related
or unrelated to MCS-2. If unrelated, please discuss the related AEs listed in the table and
discuss how you concluded that phase III OLEs has an excellent safety profile after 52
weeks.
PCP
Anti-inflammatory Activity, page 109
30.We note you reference a diagram illustrating how IL-6-mediated inflammation can be a
therapeutic target for prostate cancer. Please include the diagram or remove such
statement.

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 Comapany NameJyong Biotech Ltd.
 April 15, 2023 Page 6
 FirstName LastNameFu-Feng Kuo
Jyong Biotech Ltd.
April 15, 2023
Page 6
Commercialization Strategies, page 112
31.We refer to your risk factor disclosure on page 14. Please revise to identify and discuss the
“other marketing channels” to sell MCS-2.
32.Please revise your disclosures on page 112 to discuss your US commercialization and
pricing strategies. In this regard, your disclosures in these two sections are limited to your
plans for Taiwan.
IC
Clinical Data
Preclinical Studies, page 112
33.In your preclinical studies of IC you note that the particle size distribution is narrow with
low polydispersity indicating that a highly homogeneous microemulsion has been
successfully prepared. Please define microemulsion and discuss the relevance of the initial
findings.
Taizhou Collaboration Framework Agreement, page 113
34.Please revise to disclose the term and termination provisions for the 2018 and 2019
agreements and file them as exhibits or advise.
Intellectual Property
Patents, page 116
35.We note the table you provided listing all key patents as of the date of this prospectus.
Please also include the type of patent protection (i.e. composition of matter, use, or
process) and whether the patents have been granted or whether patent applications are
pending.
Employees, page 117
36.Please update your Employees and Facilities disclosures, which currently reflect the status
of your business as of June 2022.
Management
Directors and Executive Officers, page 149
37.We note your descriptions of each executive officer and director. Please revise to describe
the business experience during the past five years of each executive officer and director.
For instance, we note that the discussion for Dr. Fenglin Hsu does not cover this period.
Please refer to Item 401(e)(1) of Regulation S-K.
7. Leases, page F-16
38.If material, please disclose the amount related to your land use rights agreement acquired

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 April 15, 2023 Page 7
 FirstName LastName
Fu-Feng Kuo
Jyong Biotech Ltd.
April 15, 2023
Page 7
from the Bureau of Natural Resources and Planning in Taizhou, China reported within the
Operating right-of-use assets on your balance sheets.  Please disclose in the filing the
anticipated costs, timing, and funding sources related to the building of your Factory
Project.
General
39.Please provide us with copies of all written communications, as defined in Rule 405 under
the Securities Act, that you, or anyone authorized to do so on your behalf, present to
potential investors in reliance on Section 5(d) of the Securities Act, whether or not they
retain copies of the communications. Please contact the staff member associated with the
review of this filing to discuss how to submit such copies.
            You may contact Ibolya Ignat at (202) 551-3636 or Mary Mast at (202) 551-3613 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Doris Stacey Gama at (202) 551-3188 or Joe McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Yang Ge