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SEC Comment Letter 0000000000-23-006237 to Jyong Biotech Ltd. (MENS)

Jyong Biotech Ltd.
Date: June 9, 2023 · CIK: 0001954488 · Accession: 0000000000-23-006237

AI Filing Summary & Sentiment

Date
June 9, 2023
Author
Not clearly detected
Form
UPLOAD
Company
Jyong Biotech Ltd.

Letter

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

FirstName LastNameFu-Feng Kuo Comapany NameJyong Biotech Ltd. June 9, 2023 Page 2 FirstName LastName 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. Further, in the pros section for MCS-2 please remove statement that MCS-2 has a "good clinical safety profile" as safety determinations are solely within the authority of the FDA or applicable foreign regulator.

FirstName LastNameFu-Feng Kuo Comapany NameJyong Biotech Ltd. June 9, 2023 Page 3 FirstName LastName Fu-Feng Kuo Jyong Biotech Ltd. June 9, 2023 Page 3 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.

FirstName LastNameFu-Feng Kuo Comapany NameJyong Biotech Ltd. June 9, 2023 Page 4 FirstName LastName Fu-Feng Kuo Jyong Biotech Ltd. June 9, 2023 Page 4 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.

FirstName LastNameFu-Feng Kuo Comapany NameJyong Biotech Ltd. June 9, 2023 Page 5 FirstName LastName Fu-Feng Kuo Jyong Biotech Ltd. June 9, 2023 Page 5 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

Show Raw Text
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

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 June 9, 2023 Page 2
 FirstName LastName
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.
Further, in the pros section for MCS-2 please remove statement that MCS-2 has a "good
clinical safety profile" as safety determinations are solely within the authority of the FDA
or applicable foreign regulator.

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 June 9, 2023 Page 3
 FirstName LastName
Fu-Feng Kuo
Jyong Biotech Ltd.
June 9, 2023
Page 3
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.

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 June 9, 2023 Page 4
 FirstName LastName
Fu-Feng Kuo
Jyong Biotech Ltd.
June 9, 2023
Page 4
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.

 FirstName LastNameFu-Feng Kuo
 Comapany NameJyong Biotech Ltd.
 June 9, 2023 Page 5
 FirstName LastName
Fu-Feng Kuo
Jyong Biotech Ltd.
June 9, 2023
Page 5
            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