<SEC-DOCUMENT>0000000000-23-006237.txt : 20250807
<SEC-HEADER>0000000000-23-006237.hdr.sgml : 20250807
<ACCEPTANCE-DATETIME>20230609163007
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-23-006237
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20230609

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:	377-06632

	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:		0001213900-23-020402
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                               June 9, 2023

       Fu-Feng Kuo
       Chief Executive Officer
       Jyong Biotech Ltd.
       23F, No. 95, Section 1, Xintai 5th Road,
       Xizhi District, New Taipei City,
       Taiwan, 221

                                                        Re: Jyong Biotech Ltd.
                                                            Amendment No. 1 to
Draft Registration Statement on Form F-1
                                                            Submitted May 22,
2023
                                                            CIK No. 0001954488

       Dear Fu-Feng Kuo:

             We have reviewed your amended draft registration statement and
have the following
       comments. In some of our comments, we may ask you to provide us with
information so we
       may better understand your disclosure.

              Please respond to this letter by providing the requested
information and either submitting
       an amended draft registration statement or publicly filing your
registration statement on
       EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
       believe an amendment is appropriate, please tell us why in your
response.

             After reviewing the information you provide in response to these
comments and your
       amended draft registration statement or filed registration statement, we
may have additional
       comments.

       Amendment No. 1 to Draft Registration Statement on Form F-1

       Prospectus Summary
       Overview, page 2

   1.                                                   We note your response
to prior comment 4 indicating that your two leading drug
                                                        candidates MCS-2 and
PCP contain the same    drug substances.    Please revise to disclose
                                                        this point. Recognizing
that you are targeting two different indications and utilizing two
                                                        different drug names,
revise to explain whether and, if so how MCS-2 and PCP differ in
                                                        terms of composition.
For instance, and with reference to your disclosure on page 52,
                                                        explain whether they
contain the same or different active ingredients, dosage form,
                                                        strength and/or route
of administration. To the extent that differences exist, please explain
 Fu-Feng Kuo
Jyong Biotech Ltd.
June 9, 2023
Page 2
         whether FDA has indicated its agreement that the same Phase 1 safety
data can be used
         for purposes of approving MCS-2 and PCP.
2.       We refer to prior comment 17 and note your revised disclosure in the
Overview section
         indicating that MCS-2 and PCP are    patented pharmaceutical
composition of carotenoids
         and that they are    plant-based.    Please revise to identify the
active pharmaceutical
         ingredient(s) contained in these candidates or advise. In this regard,
we note that your
         response to comment 7 references active pharmaceutical ingredient(s)
and your clinical
         trial disclosures on pages 103 and 110 discuss measurement of
unidentified    active
         ingredients.
3.       With reference to your response to prior comment 7, please revise your
Summary
         presentation and pipeline table to highlight that your NDA application
for your lead
         candidate MCS-2 is not complete. Clarify the reason(s) why you must
submit additional
         data to FDA and your plan to submit this related data in 2024. Explain
the work you must
         complete in order to prepare this submission. In this regard, please
identify the active
         pharmaceutical ingredient (API) that was in short supply due to
COVID-19 and clarify
         whether you need to conduct additional/new clinical trials using the
API contained in
         MCS-2 or present data to FDA showing that the replacement API should
be deemed a
         valid replacement for purposes of FDA approval. As applicable, discuss
feedback received
         from FDA on the status of the application and the related data you
must submit.
4.       We note your response to our previous comment 6. Please revise the
Summary to explain
         the meaning of the term "bespoke development strategies." With
reference to your revised
         disclosure on page 97, revise your Summary disclosure to explain the
term "I-PSS" at first
         use.
If we encounter delays..., page 17

5.       We note your revised disclosure in response to prior comment 10.
Please reconcile your
         revised disclosure on page 17 with your disclosure on page 18
indicating that you have
         experienced delays in the enrollment of patients in your clinical
trials due to government
         orders and site policies on account of the COVID-19 pandemic and the
monkeypox
         outbreak.
Industry Overview
Benign Prostatic Hyperplasia, page 91

6.     We note your response to our previous comment 14. Please revise the
table beginning on
       page 91 to reflect, if true, that FDA and/or comparable regulatory
bodies have approved
       each of the five competitive products and that MCS-2 has not been
similarly approved.
FirstName LastNameFu-Feng Kuo
       Further, in the pros section for MCS-2 please remove statement that
MCS-2 has a "good
Comapany    NameJyong
       clinical          Biotech
                safety profile"  as Ltd.
                                    safety determinations are solely within the
authority of the FDA
       or applicable
June 9, 2023 Page 2   foreign  regulator.
FirstName LastName
 Fu-Feng Kuo
FirstName  LastNameFu-Feng  Kuo
Jyong Biotech Ltd.
Comapany
June 9, 2023NameJyong Biotech Ltd.
June 9,
Page 3 2023 Page 3
FirstName LastName
Business
Overview, page 97

7.       We note your response to our previous comment 16 and reissue. 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:
             "It is a new drug developed for BH/LUTS treatment with safety and
efficacy." (pg.
              78, 91,101)
             "MCS-2 showed safety in both short-term and long-term" (pg. 97)
             "which shew (sic) good safety profile of MCS-2." (pg. 105)
             "According to the results of phase III OLEs, MCS-2 softgels showed
safety" (pg.
              107)
Our Drug Candidates
Drug Candidate
MCS-2
Mechanism of Action, page 102

8.       We note your response to our previous comment 5 and the inclusion of
the graph on page
         103. Please revise the graphic and accompanying text to explain how
the graph shows that
         MCS-2 has anti-inflammatory activity. In this regard, please revise to
define LPS, BDS,
         and the symbols used above the bar graph.
Phase I Clinical Studies
Pharmacokinetics, page 103

9.       For the table on page 103 indicating the concentration of active
ingredients in the serum,
         please define AUC, C, t and the accompanying subscripts. Identify the
active ingredients.
Clinical Data, page 104

10.      We note your use of P-values and R-values on pages 104 and 106. Please
explain what the
         disclosed P-values and R-values indicate about statistical
significance and correlation.
11.      We note your response to prior comment 19 and reissue. Please revise
your disclosure to
         explain why your clinical trials were not conducted in sequential
order and why the NDA
         submission was made four years after the last clinical trial was
completed.
 Fu-Feng Kuo
FirstName  LastNameFu-Feng  Kuo
Jyong Biotech Ltd.
Comapany
June 9, 2023NameJyong Biotech Ltd.
June 9,
Page 4 2023 Page 4
FirstName LastName
Clinical Drug-Drug Interaction, page 104

12.      We note your response to our previous comment 23 and reissue. Please
expand to discuss
         bupropion and midazolam and the significance of your results in this
study as well as the
         clinical drug interaction study of PCP on page 110. In this regard,
please clarify what
         indication or indications are treated with bupropion and/or midazolam.
PCP
Anti-inflammatory Activity, page 110

13.      We note the inclusion of the graph on page 110 in response to our
previous comment 30.
         Please amend to include a brief description of the symbols used within
the graph.
Patents, page 116

14.      Please revise to disclose the patent numbers for your two granted US
composition of
         matter patents. Tell us whether MCS-2 are PCP are covered by the same
or different
         composition of matter patents. Also indicate whether IC is covered by
one of these two
         granted patents.
Management
Directors and Executive Officers, page 151

15.      Please revise to disclose the duration of Mr. Ming Tsan Hsu tenure as
deputy chairman of
         the board of directors at Joyear Construction Co., Ltd and supervisor
of Duennien
         Construction Co., Ltd.
Consolidated Financial Statements, page F-1

16.      Please update your financial statements and corresponding financial
information
         throughout the filing to comply with Item 8.A.4 of Form 20-F.
Notes to Consolidated Financial Statements
17. Commitments and Contingencies
Litigation, page F-24

17.      You disclose that the Group is not aware of any current pending legal
matters or claims
         except for those disclosed in this prospectus. Please revise to
provide disclosure related to
         the TaiZhou litigation matter pursuant to ASC 450-20-50 since the case
appears to be
         ongoing. Tell us also how you considered including a discussion of
this matter in your
         subsequent events note on page F- 24.
 Fu-Feng Kuo
FirstName  LastNameFu-Feng  Kuo
Jyong Biotech Ltd.
Comapany
June 9, 2023NameJyong Biotech Ltd.
June 9,
Page 5 2023 Page 5
FirstName LastName
       You may 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 Joe McCann at 202-551-6262 with
any other
questions.



                                                         Sincerely,

                                                         Division of
Corporation Finance
                                                         Office of Life
Sciences
cc:      Yang Ge
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</DOCUMENT>
</SEC-DOCUMENT>
