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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30, 2022 with a discussion of the likely consequences if you had not withdrawn your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

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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.

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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.

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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

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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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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