SecProbe.io

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
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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
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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
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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.