<SEC-DOCUMENT>0000000000-24-003666.txt : 20250807
<SEC-HEADER>0000000000-24-003666.hdr.sgml : 20250807
<ACCEPTANCE-DATETIME>20240404183605
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-24-003666
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20240404

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Jyong Biotech Ltd.
		CENTRAL INDEX KEY:			0001954488
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				000000000
		STATE OF INCORPORATION:			E9

	FILING VALUES:
		FORM TYPE:		UPLOAD
		SEC FILE NUMBER:	377-07118

	BUSINESS ADDRESS:	
		STREET 1:		23F-3, NO.95, SEC. 1, XINTAI 5TH RD.
		STREET 2:		XIZHI DIST.
		CITY:			NEW TAIPEI CITY
		STATE:			F5
		ZIP:			221
		BUSINESS PHONE:		(8862) 27325205

	MAIL ADDRESS:	
		STREET 1:		23F-3, NO.95, SEC. 1, XINTAI 5TH RD.
		STREET 2:		XIZHI DIST.
		CITY:			NEW TAIPEI CITY
		STATE:			F5
		ZIP:			221
PUBLIC REFERENCE ACCESSION NUMBER:		0001213900-24-019473
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                             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
 Fu-Feng Kuo
FirstName   LastNameFu-Feng Kuo
Jyong Biotech   Ltd.
Comapany
April       NameJyong Biotech Ltd.
       4, 2024
April 24, 2024 Page 2
Page
FirstName LastName
         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.
 Fu-Feng Kuo
FirstName   LastNameFu-Feng Kuo
Jyong Biotech   Ltd.
Comapany
April       NameJyong Biotech Ltd.
       4, 2024
April 34, 2024 Page 3
Page
FirstName LastName
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.
 Fu-Feng Kuo
FirstName   LastNameFu-Feng Kuo
Jyong Biotech   Ltd.
Comapany
April       NameJyong Biotech Ltd.
       4, 2024
April 44, 2024 Page 4
Page
FirstName LastName
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
 Fu-Feng Kuo
FirstName   LastNameFu-Feng Kuo
Jyong Biotech   Ltd.
Comapany
April       NameJyong Biotech Ltd.
       4, 2024
April 54, 2024 Page 5
Page
FirstName LastName
         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
 Fu-Feng Kuo
FirstName   LastNameFu-Feng Kuo
Jyong Biotech   Ltd.
Comapany
April       NameJyong Biotech Ltd.
       4, 2024
April 64, 2024 Page 6
Page
FirstName LastName
         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 initiate and conclude the construction of the Factory
Project in accordance
         with the schedule stipulated by the 2019 Taizhou agreement, currently
discussed in Note
         17. Disclose the expected financial statement impact of such
developments on your
         reported balances, and related disclosures as required by ASC
855-10-50-2.b, if material.
         We note that you plan to use approximately 10.0% of the net proceeds
of your initial
         public offering for (i) a possible settlement of the litigation with
Taizhou Bay New
 Fu-Feng Kuo
Jyong Biotech Ltd.
April 4, 2024
Page 7
       District Administrative Committee, including the return of government
subsidy, litigation
       expenses and interest expenses, and (ii) commitments with Taizhou
Resources Bureau,
       including liquidated damages and land idling fees, which implies that
you may be able to
       quantify the financial statement impact. Provide us supplementally the
details of
       the accounting treatment applicable for the subsequent legal
developments.
General

30.    Please supplementally provide us with copies of all written
communications, as defined in
       Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
       present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
       not they retain copies of the communications.
        We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

       Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.

       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,
FirstName LastNameFu-Feng Kuo
                                                             Division of
Corporation Finance
Comapany NameJyong Biotech Ltd.
                                                             Office of Life
Sciences
April 4, 2024 Page 7
cc:       Ross Carmel, Esq.
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
