<SEC-DOCUMENT>0001104659-21-144411.txt : 20211129
<SEC-HEADER>0001104659-21-144411.hdr.sgml : 20211129
<ACCEPTANCE-DATETIME>20211129160523
ACCESSION NUMBER:		0001104659-21-144411
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20211129
FILED AS OF DATE:		20211129
DATE AS OF CHANGE:		20211129

FILER:

	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:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39997
		FILM NUMBER:		211456174

	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
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<TYPE>6-K
<SEQUENCE>1
<FILENAME>tm2134062d1_6k.htm
<DESCRIPTION>FORM 6-K
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<P STYLE="margin: 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>WASHINGTON, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM&nbsp;6-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>REPORT OF FOREIGN PRIVATE ISSUER</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PURSUANT TO RULE 13a-16 OR 15d-16</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>For the Month of November&nbsp;2021</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Commission File Number: 001-39997</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Adagene Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact Name of Registrant as Specified in Its Charter)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>4F, Building C14, No.&nbsp;218</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Xinghu Street, Suzhou Industrial Park</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Suzhou, Jiangsu Province, 215123</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>People&#8217;s Republic of China</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>+86-512-8777-3632</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address of principal executive offices)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Indicate by check mark whether the registrant files or will file annual
reports under cover of Form&nbsp;20-F or Form&nbsp;40-F.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">Form&nbsp;20-F
</FONT><FONT STYLE="font-family: Wingdings">x</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp; <B>&nbsp;</B>Form&nbsp;40-F
</FONT><FONT STYLE="font-family: Wingdings">o</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">Indicate by
check mark if the registrant is submitting the Form&nbsp;6-K in paper as permitted by Regulation S-T Rule&nbsp;101(b)(1): </FONT><FONT STYLE="font-family: Wingdings">o</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">Indicate by
check mark if the registrant is submitting the Form&nbsp;6-K in paper as permitted by Regulation S-T Rule&nbsp;101(b)(7): </FONT><FONT STYLE="font-family: Wingdings">o</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0">Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="padding-right: 1.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Adagene Inc.</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 4%; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="width: 46%; padding-right: 0.8pt">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:&nbsp;&nbsp;</FONT></TD>
    <TD STYLE="border-bottom: black 1pt solid; padding-right: 0.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Peter (Peizhi) Luo</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="padding-right: 1.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name: Peter (Peizhi) Luo</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="padding-right: 1.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title: Chief Executive Officer</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="padding-right: 1.8pt">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: November&nbsp;29, 2021</FONT></TD>
    <TD COLSPAN="2" STYLE="padding-right: 1.8pt">&nbsp;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>EXHIBIT&nbsp;INDEX</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD STYLE="width: 10%; border-bottom: black 1pt solid; padding-right: 0.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Exhibit</B></FONT></TD>
    <TD STYLE="width: 3%; padding-right: 0.8pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 87%; border-bottom: black 1pt solid; padding-right: 0.8pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Description</B></FONT></TD></TR>
  <TR>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="text-align: left; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Press Release titled &#8220;Adagene Announces FDA Clearance of IND for Phase 1b/2 Trial of Anti-CTLA-4 Monoclonal Antibody ADG116 in Combination Therapy with Anti-PD-1
Antibody Pembrolizumab&#8221; </FONT></TD></TR>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tm2134062d1_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><FONT STYLE="font-size: 10pt">Exhibit 99.1&nbsp;</FONT></P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 10pt"><B>&nbsp;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Adagene Announces <FONT STYLE="font-size: 10pt">FDA
Clearance of IND for Phase 1b/2 Trial of Anti-CTLA-4 Monoclonal Antibody <BR>
ADG116 in Combination Therapy with Anti-PD-1 Antibody Pembrolizumab</FONT></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>- ADG116-P001 trial being initiated at multiple
sites with dosing to begin early 2022&nbsp;- </I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">SAN DIEGO and SUZHOU, China, November 29, 2021&nbsp;&ndash; Adagene
Inc. (&ldquo;Adagene&rdquo;) (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the
discovery and development of novel antibody-based immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has
cleared the Investigational New Drug (IND) application to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody
(mAb), ADG116, in combination with the anti-PD-1 antibody, pembrolizumab. The global trial (ADG116-P001 / KEYNOTE-C97) will evaluate patients
with advanced/metastatic solid tumors at multiple sites in the U.S. and <FONT STYLE="color: #333333; background-color: white">Asia Pacific
(APAC)</FONT>.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">ADG116 utilizes Adagene&rsquo;s proprietary NEObody&trade; platform
technology and is designed to target a unique conserved epitope of CTLA-4 with enhanced efficacy by potent Treg depletion in the tumor
microenvironment (TME). ADG116 is designed with a soft ligand blocking to address safety concerns associated with existing CTLA-4 therapeutics.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&ldquo;The FDA clearance of this trial represents a significant milestone
for our anti-CTLA-4 program as we advance our evaluation of ADG116 in combination with anti-PD-1 therapy,&rdquo; said Peter Luo, Ph.D.,
Co-founder, Chief Executive Officer and Chairman of Adagene. &ldquo;By applying NEObody technology, ADG116 can overcome existing safety
limitations of anti-CTLA-4 therapies to achieve improved clinical benefit. Our exploration of ADG116 with pembrolizumab aims to unleash
the dual CTLA-4/PD-1 blockade and realize the full potential of this combination therapy approach as a cornerstone of cancer treatment
 &ndash; balancing safety and efficacy.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The ADG116-P001 trial is expected to dose the first patient in early
2022, and is designed to evaluate the safety and tolerability, determine the maximum tolerated dose, and assess preliminary efficacy of
the combination of ADG116 and pembrolizumab.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Additionally, the ongoing ADG116-1003 trial is on track to expand with
two combination cohorts investigating safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic
solid tumors.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About Adagene</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical
company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational
biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary Dynamic Precision
Library (DPL) platform, composed of NEObody, SAFEbody&trade;, and POWERbody&trade; technologies, Adagene&rsquo;s highly differentiated
pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage
its technology in multiple approaches at the vanguard of science.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">For more information, please visit:&nbsp;<U>https://investor.adagene.com</U>.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Safe Harbor Statement</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">This press release contains forward-looking statements, including statements
regarding the potential implications of clinical data for patients, and Adagene&rsquo;s advancement of, and anticipated clinical activities,
clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from
those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene&rsquo;s
ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support
further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding
regulatory approval of Adagene&rsquo;s drug candidates; Adagene&rsquo;s ability to achieve commercial success for its drug candidates,
if approved; Adagene&rsquo;s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene&rsquo;s
reliance on third parties to conduct drug development, manufacturing and other services; Adagene&rsquo;s limited operating history and
Adagene&rsquo;s ability to obtain additional funding for operations and to complete the development and commercialization of its drug
candidates; Adagene&rsquo;s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations,
and the impact of the COVID-19 pandemic on Adagene&rsquo;s clinical development, commercial and other operations, as well as those risks
more fully discussed in the &ldquo;Risk Factors&rdquo; section in Adagene&rsquo;s filings with the U.S. Securities and Exchange Commission.
All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be
required by law.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Internal Contact</B>:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Ami Knoefler<BR>
Adagene<BR>
650-739-9952<BR>
<U>ir@adagene.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>External Contact: </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Bruce Mackle<BR>
LifeSci Advisors<BR>
646-889-1200<BR>
<U>bmackle@lifesciadvisors.com</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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