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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.

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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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May 31, 2024
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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
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            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.