United States securities and exchange commission logo

                              October 19, 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.
                                                            Draft Registration
Statement on Form F-1
                                                            Submitted September
22, 2020
                                                            CIK No.: 0001818838

       Dear Mr. Luo:

              We have reviewed your 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

             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

       Draft Registration Statement on Form F-1 Submitted on September 22, 2020

       Prospectus Summary
       Overview, page 1

   1.                                                   Please substantially
revise your narrative disclosures to more clearly explain in plain
                                                        English your NEObody,
SAFEbody, and POWERbody technologies, and how they are
                                                        inter-connected and
utilized for the building of your product pipeline. Also expand your
                                                        explanations of the
figures at the top of pages 2 and 3 (and in your Business sections),
                                                        including with respect
to the images in each of the three circles in the figure on page 3.
 Peter (Peizhi) Luo
FirstName  LastNamePeter (Peizhi) Luo
Adagene Inc.
October  19,NameAdagene
             2020        Inc.
Page  2 19, 2020 Page 2
FirstName LastName
2.       We refer to your statements on pages 4 and 6 and in your Business
section comparing the
         safety of ADG126 with ipilimumab based on a separate study. As this
comparison is not
         based on head-to-head studies, please delete these discussions, or
3.       Revise to limit your Summary discussion of your ongoing trials to
serious adverse events,
         trial endpoints, and to the extent applicable, whether they were met.
In the Business
         section discussion of preliminary efficacy assessments, clarify, if
true, that the trials did
         not have efficacy endpoints.
Our Pipeline, page 4

4.       With respect to your product candidates other than ADG106 and ADG104,
revise your
         column headings to show "Phase II" as a separate column or otherwise
advise. With
         respect to ADG106, please explain why the table does not show separate
Phase I and
         Phase II columns when your narrative disclosure appears to refer to
separate phases. In
         addition, based on your narrative disclosure regarding your status of
development for
         ADG106, please shorten the arrows in your pipeline table to more
precisely indicate the
         development status of such product candidate, or advise, and shorten
your arrow for
         ADG116 to the end of the IND enabling column as it does not appear you
         commenced your Phase 1 Australia trial yet based on your narrative
disclosures, and it
         does not appear you are intending to rely on the paused U.S. trial.
5.       Please revise your pipeline table to show the target indications of
each included product
         candidate. In addition, please explain why it is appropriate for your
pipeline table to
         include a row generally for "Preclinical Assets." Based on your
discussion in the Business
         section, these assets appear to be in an early stage of development,
and it does not appear
         that you have identified any specific preclinical candidates to
ADG106: Novel agonistic anti-CD137 NEObody candidate, page 5

6.       We note your disclosure on page 5 and elsewhere in your prospectus
that in preclinical
         and clinical trials, your product candidate has shown "robust
anti-tumor activity," "was
         observed to balance between safety and efficacy of CD137 agonism,"
         "favorable safety results," "potent antitumor efficacy" and
"preliminary clinical efficacy,"
         and you also refer to "effective doses." Similar statements appear
elsewhere in your
         prospectus, such as your statement on page 42 referring to the
"significant safety
         margin" of ADG126, and your statement on page 151 that ADG126 "was
observed to
         effectively inhibit tumor growth." Please revise your disclosures to
remove all such
         statements suggesting that your product candidate is safe or
effective, insofar as
         determinations as to safety and efficacy are within the sole authority
of the FDA or
         comparable foreign regulatory authorities.
ADG116: Novel anti-CTLA-4 NEObody candidate, page 7

7.       We note your disclosure that you have a Phase I clinical trial open in
the United States for
         ADG116 as a monotherapy in patients with advanced/metastatic solid
tumors, but that you
 Peter (Peizhi) Luo
FirstName  LastNamePeter (Peizhi) Luo
Adagene Inc.
October  19,NameAdagene
             2020        Inc.
Page  3 19, 2020 Page 3
FirstName LastName
         are not enrolling patients in the trial. Revise to disclose in your
Summary that your Phase I
         trial was placed on clinical hold by the FDA following a death of a
patient, as you explain
         on page 31, and that you intend to conduct your trial in Australia at
higher starting doses
         than is currently permitted in the U.S.
Our Global Partnership and Collaborations, page 7

8.       We note your statement that your recent partnerships are "validations
of [y]our DPL
         platform and technologies as well as their potential broad application
to a wide range of
         antibody modalities.    Given the early stage of development of your
product candidates
         derived from the platform and your partnerships and collaborations,
such statements imply
         an expectation of regulatory approval and are inappropriate given the
length of time and
         uncertainty with respect to securing such approval. Please delete such
statements here and
         in the Business section. In addition, please qualify the fourth bullet
on page 8 to state that
         you may not be able to enter into additional collaboration agreements
beyond the ones
         with ADC Therapeutics and Guilin Sanjin.
Risk Factors, page 8

9.       Please add a bullet to highlight that you may be classified as a PFIC
for the current taxable
         year and the resulting consequence to investors.
Implications of Being an Emerging Growth Company, page 10

10.      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.
Risks Factors, page 18

11.      We note your disclosure on page 224 that certain shareholders will
possess board
         representation rights following the offering. Please add a risk factor
         the board representation rights in sufficient detail so that investors
can clearly understand
         the corporate governance, control of the company, and resulting
conflicts of interest that
         may arise. For example, include in your revised disclosure that your
CEO has such rights,
         and if true, that your sole supplier is also a significant shareholder
with these rights. In
         addition, please also add appropriate disclosure in the summary risk
factors disclosing that
         certain shareholders will have board representation rights.
Use of Proceeds, page 96

12.      Please expand your bullet points to disclose the estimated proceeds to
be allocated to each
         of your target indications and product candidates and clarify the
stage of development you
         expect to be able to complete for each indication using the estimated
proceeds. In
         addition, please add disclosure to the extent you will need additional
funds to further
 Peter (Peizhi) Luo
FirstName  LastNamePeter (Peizhi) Luo
Adagene Inc.
October  19,NameAdagene
             2020        Inc.
Page  4 19, 2020 Page 4
FirstName LastName
         develop your material product candidates.
Capitalization, page 98

13.      Please revise long-term borrowings to include the current portion of
Results of Operations, page 111

14.      For research and development expenses, please separately present the
costs incurred for
         preclinical testing from costs incurred for clinical trials. Please
disclose the amount of
         costs incurred by program for each period presented.
Management   s Discussion and Analysis of Financial Condition and Results of
Share-based Compensation, page 123

15.      Once you have an estimated offering price or range, please explain to
us how you
         determined the fair value of the common stock underlying your equity
issuances and the
         reasons for any differences between the recent valuations of your
common stock leading
         up to the IPO and the estimated offering price. This information will
help facilitate our
         review of your accounting for equity issuances. Please discuss with
the staff how to
         submit your response.
Our Pipeline
ADG106: Novel Agonistic Anti-CD137 NEObody Candidate
Mechanism of Action, page 136

16.      Please include additional descriptive labels for the figures at the
top of page 137.
         Specifically, please clearly label ADG106 in addition to the other
objects depicted or
         otherwise revise the graphic to clarify this illustration.
Clinical Development Plan, page 147

17.      We note your disclosure that you are conducting a Phase Ib cohort
expansion for
         ADG106. In conjunction with your disclosure on page 139, revise to
clarify the material
         details on the expansion trial, including the number of expected
participants, trial design,
         endpoints and any protocols.
ADG116: Novel Anti-CTLA-4 NEObody Candidate, page 152

18.      Expand your disclosure regarding your trials with ADG116 to describe
the Phase I trial
         that occurred in the U.S. prior to its clinical hold. Please also
revise to provide details for
         your planned Phase I trial in Australia, including the number of
patients, dosage, duration,
         and endpoints.
 Peter (Peizhi) Luo
FirstName  LastNamePeter (Peizhi) Luo
Adagene Inc.
October  19,NameAdagene
             2020        Inc.
Page  5 19, 2020 Page 5
FirstName LastName
Our Platform, page 161

19.      Please revise to more clearly explain to investors the technology
underlying your DPL
         platform, including by clarifying the "proven applications commonly
used in the industry"
         and whether or not you have licenses to use these applications. In
addition, please describe
         the underlying technology unique to your POWERbody technology so that
investors can
         better understand this specific technology.
ADC Therapeutics Agreements, page 164

20.      Please revise your disclosure regarding the ADC Therapeutics
Agreements to disclose the
         aggregate payments received to date.
Sanjin Collaboration/ Out-Licensing Agreements, page 165

21.      Please revise your disclosures regarding the Sanjin Greater China
Agreement and Dragon
         Boat ROW Agreement to disclose the aggregate payments received to
date. Also revise to
         specify the period Sanjin is required to pay the percentage of net
Intellectual Property, page 167

22.      Please expand the discussion of your intellectual property portfolio
on page 167 to specify
         (i) the material patents and patent applications you have for each of
your specific product
         candidates, and (ii) the type of patent protection granted or
requested (composition of
         matter, use or process) for each patent or pending application. In
addition, please revise
         your disclosure to specify the jurisdictions in Europe in which you
have pending
Competition, page 169

23.      We note that you cross-reference to "Market Opportunity and
Competition" sections
         elsewhere in the prospectus where you disclose two advanced CD137
agonist antibodies
         in development and ipilimumab as competition to ADG106 and
         ADG126, respectively. Please revise your disclosure to enhance your
description of the
         competitive business conditions you face in respect to your material
product candidates,
         including disclosing the names of your main competitors, the stages of
development for
         your competitors' candidates and if applicable competition from
existing approved
Regulation, page 172

24.      Please add a discussion regarding applicable regulation in Australia
as you disclose that
         you intend to conduct clinical trials in Australia.
Related Party Transactions, page 212

25.      Revise to clarify whether the transactions with WuXi Biologics
included providing you
 Peter (Peizhi) Luo
FirstName  LastNamePeter (Peizhi) Luo
Adagene Inc.
October  19,NameAdagene
             2020        Inc.
Page  6 19, 2020 Page 6
FirstName LastName
         with manufacturing and quality control testing, as you state on page
169 that you rely on
         WuXi for your supply needs.
Notes to the Consolidated Financial Statements
10. Collaboration Arrangements, page F-29

26.      Please expand your disclosures for the Dragon Boat Greater China
Agreement to include
         the nature of the milestones along with the US dollar amount for the
upfront fee and the
         total potential milestone payments. Refer to ASC 606-10-32.
27.      For the ADCT Collaboration and License Agreements to address the
             Clarify that the agreements are being combined for revenue
recognition purposes, if
             appropriate, per ASC 606-10-25-9.
             Clarify if you are required to perform research and development
services in addition
             to providing a license along with whether the research and
development services for
             the masked antibodies generated under the collaboration portion of
the agreement is a
             separate performance obligation. Refer to ASC 606-10-25-14 through
25-22. Please
             also tell us how this impacts revenues recognition, if at all, in
accordance with ASC
             606-10-25-23 through 25-37.
             Disclose the US dollar amount for each category of milestones that
are to be met to
             receive payments.
18. Condensed Financial Information of the Parent Company, page F-40

28.      We note that Adagene Inc., the parent company, is an offshore holding
company. As
         such, please tell us why the parent company recognized revenues,
contract liabilities, and
         research and development expenses. Please also provide footnote
disclosures for the
         amounts due from related parties and amounts due to related parties.
Please confirm that
         the changes in amounts due to related parties are reflected as cash
financing transactions
         and the amounts due from related parties are reflected as cash
investing transactions.

29.      We note your disclosure on page 171 of various lease agreements for
properties located in
         China and California. Please file your material lease agreements as
exhibits to your
         registration statement or please advise. Refer to Item 8 of Form F-1
and Item
         601(b)(10)(ii)(D) of Regulation S-K.
 Peter (Peizhi) Luo
Adagene Inc.
October 19, 2020
Page 7

       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.

FirstName LastNamePeter (Peizhi) Luo
                                                          Division of
Corporation Finance
Comapany NameAdagene Inc.
                                                          Office of Life
October 19, 2020 Page 7
cc:       Li He, Esq.
FirstName LastName