<SEC-DOCUMENT>0000000000-20-010823.txt : 20210309
<SEC-HEADER>0000000000-20-010823.hdr.sgml : 20210309
<ACCEPTANCE-DATETIME>20201112124531
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-20-010823
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20201112

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Adagene Inc.
		CENTRAL INDEX KEY:			0001818838
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			E9
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		4F, BUILDING C14, NO. 218, XINGHU STREET
		STREET 2:		SUZHOU INDUSTRIAL PARK
		CITY:			JIANGSU
		STATE:			F4
		ZIP:			00000
		BUSINESS PHONE:		86-512-87773632

	MAIL ADDRESS:	
		STREET 1:		4F, BUILDING C14, NO. 218, XINGHU STREET
		STREET 2:		SUZHOU INDUSTRIAL PARK
		CITY:			JIANGSU
		STATE:			F4
		ZIP:			00000
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<TEXT>
United States securities and exchange commission logo





                           November 10, 2020

       Peter (Peizhi) Luo
       Chief Executive Officer
       Adagene Inc.
       4F, Building C14, No. 218
       Xinghu Street, Suzhou Industrial Park
       Suzhou, Jiangsu Province, 25125
       People's Republic of China

                                                        Re: Adagene Inc.
                                                            Amendment No. 1 to
Draft Registration Statement on Form F-1
                                                            Submitted October
27, 2020
                                                            CIK No.: 0001818838

       Dear Mr. Luo:

             We have reviewed your amended draft offering 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 offering statement or publicly filing your offering
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 any amendment
       to your draft offering statement or filed offering statement and the
information you provide in
       response to these comments, we may have additional comments. Unless we
note otherwise, our
       references to prior comments are to comments in our October 19, 2020
letter.

       Draft Registration Statement on Form F-1 Submitted on October 27, 2020

       Our Pipeline, page 5

   1.                                                   We note your response
to prior comment 3 and that your disclosure states on page 6 that
                                                        there were seven SAEs
that were determined to be related to the study treatment. Please
                                                        clearly expand your
discussion in the Summary to specify the serious adverse events. We
                                                        also note your
statement on page 142 that 57% of the patients discontinued ADG106
                                                        treatment in the
ADG106-1002 trial, including three patients who discontinued due to
                                                        adverse events. Please
revise to clarify this information in the Summary, or advise.
   2.                                                   We note your response
to prior comment 4, including your revised pipeline table on page
 Peter (Peizhi) Luo
FirstName  LastNamePeter (Peizhi) Luo
Adagene Inc.
Comapany 10,
November   NameAdagene
               2020       Inc.
November
Page  2    10, 2020 Page 2
FirstName LastName
         5. Please shorten your arrow for ADG116 Trial 1003 to the beginning of
Phase Ia or
         otherwise advise. We note your disclosures elsewhere indicating that
you have dosed one
         patient in the trial in July 2020.
3.       We note your response to prior comment 24 that you do not intend to
seek approval for
         your product candidates in Australia. Please revise your disclosures
here and elsewhere as
         appropriate to clarify this intent to use the trial data to seek
approval in China and the U.S.
         Please also provide additional disclosure regarding any risks of this
approach, including
         with respect to risks relating to your ability to rely on the trial
data, or advise.
ADG116: Novel anti-CTLA-4 NEObody candidate, page 7

4.       We note your response to prior comment 7, including your revised
disclosure at the
         bottom of page 7. Please further revise to make clear that you
currently do not plan on
         enrolling patients in the U.S. trial consistent with your disclosure
on page 32.
Capitalization, page 99

5.       Please update the total capitalization amount to include the current
portion of long-term
         borrowings, which was added in response to comment 13.
ADC Therapeutics Agreements, page 168

6.       We note your response to prior comments 20, 26, and 27, and your
revised disclosures.
         Please disclose aggregate payments received to date under the ADCT
License Agreement.
         Additionally, with respect to each of the ADCT License Agreement and
the Collaboration
         Agreement, as well as the agreement with Dragon Boat, disclose the
aggregate milestones
         receivable.
Intellectual Property, page 172

7.       We note your response to our prior comment 22 and your revised
disclosures. Please
         further clarify which of the patents are already issued and which ones
are subject to
         pending patent applications.
Notes to the Consolidated Financial Statements
10. Collaboration Arrangements, page F-28

8.       As requested in comment 26, please disclose the US dollar equivalent
to the RMB
         4,000,000 upfront payment received. Please also address this comment
with your interim
         financial statements.
18. Condensed Financial Information of the Parent Company, page F-40

9.       We note your response to comment 28 in which you state that the parent
company also
         carries out research and development activities for new drug
discovery. Please help us
         understand how this statement is consistent with the disclosures made
in the Form F-1. In
 Peter (Peizhi) Luo
Adagene Inc.
November 10, 2020
Page 3
      this regard, we note on page 10 that the parent company, Adagene Inc.,
was incorporated
      in February 2011 under the laws of the Cayman Islands as an offshore
holding company.
      In December 2011, Adagene (Suzhou) Limited was incorporated in China,
through which
      you commenced research and development activities in China. On page 73,
you state that
      substantially all of your business operations are in China. On page 81,
you state that you
      are an offshore holding company conducting your operations in China
through your PRC
      subsidiary and that you make loans to the PRC subsidiary. Further, we
note that the
      auditors are located in and organized under the laws of the PRC. As such,
it remains
      unclear why you continue to reflect operating activity (contract
liabilities, revenues,
      research and development expenses) in your standalone financial
statements as that of the
      parent company rather than of the subsidiaries formed to conduct the
operations of the
      entity. It further remains unclear how you are (1) able to recognize
income from equity
      method investees, as no profits have been recognized, and (2) recognize
loans to and from
      your subsidiaries as operating activities as you are stated to be a
holding company with no
      stated operating activities located in the Cayman Islands. Please advise
and revise the
      disclosures and presentations in the document accordingly.
       You may contact Tracey Houser at 202-551-3736 or Terence O'Brien at
202-551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jason Drory at 202-551-8342 or Dorrie Yale at 202-551-8776 with any
other questions.



                                                           Sincerely,
FirstName LastNamePeter (Peizhi) Luo
                                                           Division of
Corporation Finance
Comapany NameAdagene Inc.
                                                           Office of Life
Sciences
November 10, 2020 Page 3
cc:       Li He, Esq.
FirstName LastName
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