SecProbe.io

July 19, 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. 2 to Registration Statement on Form F-1
Filed June 21, 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 May 31, 2024 letter.
Amendment No. 2 to Registration Statement on Form F-1
Prospectus Summary
Overview, page 1
1.Please revise the discussion of your current plans to develop MCS-2 (API-2) to clarify the
FDA’s concerns communicated on pages 1-2 of its February 23, 2024 correspondence,
which you provided in response to our May 31, 2024 request. The communication
indicates that your proposed plan to conduct one phase 1 study and one phase 3 efficacy
study using your product containing API-2 faces significant challenges. Please update
your Summary to briefly describe the FDA’s concerns and provide a more fulsome
discussion of these concerns in the Business section.
We note your response to prior comment 1 and reissue in part. Please revise your
disclosure throughout your filing to remove language indicating that the comparability is 2.

July 19, 2024
Page 2
an inevitable conclusion, such as "[O]nce the US FDA is convinced about the
comparability of API-1 and API-2...."  You may discuss what happens if you are able to
demonstrate comparability, but you must indicate that to date you have not been able to
do so and what your path forward is if you are unable to demonstrate comparability.
Please also state if you have had discussions with the Taiwan regulator about the
substitution of API-2 for API-1 in MCS-2. If you have not, or if the Taiwan regulator also
requires comparability studies, it is not appropriate to indicate that you have completed
Phase 1 studies for PCP (API-1).
3.In response to prior comment 1 you state that you are preparing CMC information for
API-2, are planning to establish comparability between API-1 and API-2, and once the
FDA is convinced about the comparability you will then initiate the MCS-2 Phase III and
Phase I PK study. Please revise your disclosure to state that you currently do not have an
API-2 supplier and that you cannot proceed until you identify a supplier of API-2. Please
also include such disclosure throughout your prospectus where you discuss PCP,
including but not limited to pages 6, 109, and 124. Additionally include a risk factor
discussion addressing the potential consequences if the FDA does not agree that API-1 is
comparable to API-2.
4.In response to prior comment 4 you state that you plan to demonstrate that API-1 and
API-2 are comparable to be able to rely on all prior trials. You also state that due to a
failed MCS-2-US-a study you will conduct an additional Phase III pivotal study in the US
using API-2. Please clarify, if accurate, that you must first conduct API-1 and API-2
comparability studies and if the FDA accepts such results and determines that API-1 and
API-2 are comparable, only then will you be able to conduct the additional Phase III
pivotal study using API-2. Further, you also state that your plans will be discussed at the
CMC meeting. Clarify, as you do on page 2, that you received a denial notice from the
FDA on May 23, 2024 for a CMC meeting.
We note your response to comment 5 and 6. Your pipeline table should provide one line
for each product candidate being developed to address a single indication. The purpose of
the pipeline table is not to depict the alternative ways you may develop the same product
candidate. Currently, your table depicts three lines depicting MCS-2 being developed to
address BPH/LUTS. Please revise your table to remove two of the lines depicting MCS-2
for BPH/LUTS as they are not additional candidates, they are alternative ways that you
may attempt to develop MCS-2 for BPH/LUTS. The line item that should be depicted in
the table is the one that depicts the method of development you are actively pursuing with
the FDA.

If you are able to rely on trials performed using API-1, it is not appropriate to include a
separate line item in your table indicating that you have a separate product candidate for
MCS-2 (API-1). If the FDA determines that API-1 and API-2 are sufficiently comparable
to rely on the clinical trials performed using API-1, then you may reflect the completion
of the successful trials using API-1 in your pipeline table for the line item depicting the
development of MCS-2 (API-2). Until the FDA has made that comparability
determination, such results relating to API-1 relate to a development pathway that you are
not currently able to pursue due to the fact that API-1 is currently not available. Similarly,
if the new Phase III study using API-2 is successful and you are able to demonstrate to the 5.

July 19, 2024
Page 3
FDA that API-1 and API-2 are sufficiently comparable, then you will be able to rely on
the MCS-2-TWN-a study in the pipeline table if you have been able to re-analyze the data
from the study to successfully demonstrate to the FDA that it is reliable.

We also note your table indicates you are developing PCP (API-1) for Prostate Cancer in
Taiwan. Please explain how you are pursuing this using API-1 given that API-1 is not
currently available. Alternatively, remove it from your pipeline table.
6.We note your response to prior comment 8 and reissue our comment. Please refer to page
2 of 7 from the FDA correspondence dated 26, 2023 you provided in response to our
request on May 31, 2024, which states:
"Because of the heterogeneous nature of a botanical drug and uncertainty about its active
constituents a critical issue for botanical drugs is ensuring that the therapeutic effect for
drug batches is consistent. In general, therapeutic consistency can be supported by a
'totality of the evidence' approach, including botanical raw material control, quality
control, by chemical test(s), manufacturing control, a biological assay (if needed) and
clinical data. Seemingly minor changes in the API source and/or manufacturing process
may result in a meaningful difference in the clinical effects and raise concerns about the
applicability of earlier pharmacological, nonclinical and clinical data."

See also pages 2-3 of 10 which states, "any changes (e.g. changes in the agricultural sites,
agricultural and collection practices and/or processing/manufacturing methods) should be
assessed carefully to determine if the BDS and the botanical drug product (BDP) batches
produced after such a proposed change would be sufficiently similar pharmacologically
and/or therapeutically to batches prior to such a change."

Please note the potential impact of these "seemingly minor changes" apply to changes in
suppliers of the active pharmaceutical ingredient as well as the change in the active
pharmaceutical ingredient provided by the supplier of API-1 prior to its relocation and
following its relocation. Therefore, in order to produce MCS-2 using API-1 following a
relocation, you would have to demonstrate comparability again. Please revise your
disclosure to clarify that if you intend to develop MCS-2 using API-1 if it becomes
available, you will have to demonstrate comparability again. If you are unable to
demonstrate comparability, you will have to perform more clinical trials.
7.Please provide us with a copy of the FDA meeting minutes from your January 20, 2013
CMC meeting in which the FDA staff encouraged you to select multiple vendors for the
botanical raw material and advised you to identify more raw material vendors to avoid
any potential supply shortages in the early stages. The June 26, 2023 FDA
correspondence you provided indicates that "minor changes in the API source and/or
manufacturing process may result in a meaningful difference in the clinical effects and
raise concerns about the applicability of earlier pharmacological, nonclinical and clinical
data" which appears inconsistent with this advice.
Risk Factors, page 17
Please include a risk factor addressing the possibility that the FDA does not agree that
API-1 and API-2 are sufficiently comparable. The discussion should address the FDA's
concerns related to changes in agricultural sites, agricultural and collection practices, 8.

July 19, 2024
Page 4
processing and manufacturing methods, etc. and the consequences if the FDA determines
that API-1 and API-2 are not sufficiently comparable.
9.Please include an additional risk factor discussing the FDA's stated concerns about your
proposed plan to conduct only one phase 1 study and one phase 3 efficacy study. The
discussion should identify the FDA's concerns you will have to address in order to
successfully develop MCS-2 (API-2), given your current plan and the potential
consequences, if you are unable to demonstrate to the FDA that your proposal is sufficient
to demonstrate safety and efficacy.
Leverage differentiated approaches to advance our development..., page 112
10.In response to prior comment 14 you state you plan to complete all source data
verification, database lock and statistical analysis, and draft the clinical study report. Such
steps appear necessary for you to advance your product candidate. You also state on page
1 that you do not plan to discuss PCP with the TFDA until after you have conducted
comparability studies. Please clarify if this process is dependent on first selecting an API-
2 supplier and conducting successful comparability studies or if you will be verifying and
analyzing the data at the same time you are performing comparability studies. Please
clarify that if the comparability studies are not successful, the PCP clinical trials will have
to be performed again using PCP (API-2).
Our Drug Candidates
Phase II Clinical Studies, page 118
11.In response to prior comment 15 we note the additional disclosure provided under Clinical
Data and Phase I Clinical Studies. Please also include disclosure under Phase II and Phase
III Clinical Studies, on pages 118 and 119 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 119
12.We note your response to prior comment 16 and reissue in part. Please clarify here, as you
do on page 123, that the remaining data you are referring to is the data from the two Phase
III studies conducted in Taiwan and the one Phase III US open label extension study. Also
include a discussion here and on page 123 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.
13.We note your response to prior comment 17. Specifically, that you will not need to
reproduce the Phase III study in US (MCS-2-US-a) if the US 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. Provide the basis for your determination that the FDA will rely on
results of trials that failed to demonstrate a difference between the treatment groups for
the primary efficacy endpoint in the intent-to-treat population. Please also include
additional disclosure stating that if the FDA does not approve your comparability studies
you will need to reproduce MCS-2 (API-1) Phase III study in the US because it failed to
show a difference between treatment groups for the primary efficacy endpoint in the
intent-to-treat population.

July 19, 2024
Page 5
14.We note that in response to prior comment 18 you removed the US-a + TWN-a/ITT
results from Table 1 and 2. However, we note that your disclosure still contains
statements such as "[a]ccording to the results of phase III clinical trials after pooling US-a
and TWN-a..." 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 throughout your
filing.
            Please contact 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.