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CORRESP
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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