SecProbe.io

CORRESP
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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“voluntarily” withdrew your NDA on November 30, 2022 with a discussion of the likely consequences if you had not withdrawn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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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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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