<SEC-DOCUMENT>0001104659-21-149334.txt : 20211214
<SEC-HEADER>0001104659-21-149334.hdr.sgml : 20211214
<ACCEPTANCE-DATETIME>20211214060351
ACCESSION NUMBER:		0001104659-21-149334
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20211214
FILED AS OF DATE:		20211214
DATE AS OF CHANGE:		20211214

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:		211489596

	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>
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<TYPE>6-K
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<FILENAME>tm2135240d1_6k.htm
<DESCRIPTION>FORM 6-K
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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 December&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">&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; 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>

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    <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: December&nbsp;14, 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; 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"><A HREF="tm2135240d1_ex99-1.htm"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></A></TD>
    <TD STYLE="vertical-align: bottom; padding-right: 0.8pt">&nbsp;</TD>
    <TD STYLE="text-align: left; vertical-align: top"><A HREF="tm2135240d1_ex99-1.htm"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Press
    Release titled &#8220;Adagene Presents Preclinical Data Showcasing Best-in-Class Profiles for ADG153, an Anti-CD47 SAFEbody<SUP>&reg;
    </SUP>and ADG152, a CD20xCD3 Bispecific T-cell Engager POWERbody&trade;&rdquo;</FONT></A></TD></TR>
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<TYPE>EX-99.1
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<FILENAME>tm2135240d1_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
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<P STYLE="text-align: right; margin: 0"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"><IMG SRC="tm2135240d1_ex99-1img001.jpg" ALT=""></P>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Adagene
Presents Preclinical Data Showcasing Best-in-Class&nbsp;Profiles for ADG153, an Anti-CD47 SAFEbody</B></FONT><B><SUP>&reg;</SUP> and
ADG152, a CD20xCD3 Bispecific T-cell Engager POWERbody&trade;</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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>-
Posters presented at the 63<SUP>rd</SUP> American Society of Hematology Annual Meeting</I></FONT> <B>-</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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>SAN
DIEGO and SUZHOU, China, December&nbsp;13, 2021&nbsp;&ndash;</B></FONT> Adagene Inc. (&ldquo;Adagene&rdquo;) (Nasdaq: ADAG), a biopharmaceutical
company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced preclinical data
demonstrating the compelling differentiation of ADG153, an anti-CD47 monoclonal antibody (mAb), and ADG152, a CD20xCD3 bispecific T-cell
engager (TCE). The data were presented in two poster presentations at the 63<SUP>rd</SUP> American Society of Hematology (ASH) Annual
Meeting&nbsp;&amp; Exposition taking place December&nbsp;11-14, 2021, which are available in the Publications section of the company&rsquo;s
website at www.adagene.com.</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; font-size: 10pt">&ldquo;Our
novel anti-CD47 antibody and CD20xCD3 bispecific TCE programs successfully leverage SAFEbody technology </FONT>for precision masking to
decouple efficacy from the toxicities that are often associated with therapeutic modalities for these two important targets on the forefront
of clinical development for hematologic malignancies,&rdquo; said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of
Adagene. &ldquo;Our preclinical evaluation shows the desirable target product profiles of these two transformative programs emerging from
our deep, broad and differentiated pipeline. In particular, we are very excited about our highly differentiated anti-CD47 SAFEbody in
IgG1 format, which introduces IgG1-mediated effects for potent tumor killing with a compelling safety profile and 8-fold prolonged half-life.
Our first POWERbody CD20xCD3 bispecific TCE with precision masking on our tailor-made anti-CD3 arm is highly differentiated, engineered
for potent and sustained tumor killing with more than 100-fold cytokine release control and 2-3-fold prolonged half-life in comparison
with a benchmarked antibody in clinical development. Together, these two programs highlight the strength of our AI-powered antibody platform,
paving the way for explosive growth of our pipeline.&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"><B>ADG153 (Anti-CD47 SAFEbody)</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">Key findings from the poster (#3342) titled &ldquo;ADG153, an Anti-CD-47
Monoclonal Antibody Prodrug, Has Strong <I>In Vivo</I> Anti-Tumor Activity, Minimal RBC-Related and Antigen Sink Liabilities, and Extended
Half Life in Comparison with Benchmark Clinical Antibodies of the Same IgG Subclass&rdquo; include:</P>

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

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<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>Given the dose-limiting hematologic toxicity and antigen sink liability associated with current anti-CD47 antibodies in clinical development,
Adagene has developed an anti-CD47 SAFEbody with precision masking for preferential binding on CD47 overexpressed on tumor versus normal
cells. To realize the full potential of anti-CD47 therapy for both hematologic and solid malignancies, the SAFEbody technology enables
IgG1-mediated strong effector functions for potent tumor killing, while minimizing antigen sink and red blood cell (RBC) depletion with
an approximately 8-fold prolonged half-life for convenient drug dosing and administration.</TD></TR></TABLE>

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

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<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>An anti-CD47 ADG153-G4 SAFEbody was designed for benchmarking and evaluated in preclinical studies in comparison with its parental
antibody, and analogs of magrolimab (Hu5F9) and <FONT STYLE="color: #333333; background-color: white">lemzoparlimab</FONT> (TJC4) in IgG4
format with the following findings:</TD></TR></TABLE>

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<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD>ADG153-G4 parental antibody and its activated SAFEbody can block the CD47 signal by targeting a unique epitope of CD47 with high affinity
and minimal RBC hemagglutination.</TD></TR></TABLE>

<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"><IMG SRC="tm2135240d1_ex99-1img001.jpg" ALT=""></P>

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

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<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD><FONT>In preclinical studies in monkeys, </FONT>ADG153-G4 showed a significantly less
decrease in RBCs and hemoglobin at the 10, 30 and 60 mg/kg dose levels compared to Hu5F9 at 10 mg/kg, addressing the hematologic toxicities
inherent in current anti-CD47 therapies in development.</TD></TR></TABLE>

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

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<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD>ADG153-G4 SAFEbody also showed its 8-fold prolonged half-life by overcoming the antigen sink observed with other anti-CD47 therapies
in development.</TD></TR></TABLE>

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<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD>Only <FONT STYLE="font-family: Times New Roman, Times, Serif; background-color: white">antibody-dependent cellular phagocytosis (ADCP)</FONT>
effector function was detected for anti-CD47 antibodies in IgG4 isotype via CD47-mediated phagocytosis by macrophage.</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>An anti-CD47 ADG153-G1 SAFEbody was designed to maximize tumor killing via IgG1-mediated effector functions unlike many other anti-CD47
therapies in development:</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: #333333">o</FONT></TD><TD>ADG153-G1 induced potent <FONT STYLE="font-family: Times New Roman, Times, Serif; background-color: white">antibody-dependent cellular
cytotoxicity (ADCC); as expected, none was observed for the <FONT STYLE="color: #111111">IgG4 benchmark antibodies.</FONT></FONT></TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD><FONT STYLE="font-family: Times New Roman, Times, Serif; color: #111111; background-color: white">ADG153-G1 induced stronger </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; background-color: white">ADCP
activity than </FONT>the IgG4 benchmark antibodies.</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>Preclinical results concluded that the ADG153-G1 can achieve potent anti-CD47 efficacy with a well-tolerated safety profile, providing
a strong rationale to advance this candidate <FONT STYLE="background-color: white">into clinic. Currently, no other known anti-CD47 antibodies
using the IgG1 isotype are in clinical development.</FONT></TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD>Notably, ADG153-G1 was well tolerated at 10 mg/kg, with only an 8 percent decrease in RBCs, compared to a 49 percent decrease with
Hu5F9 in IgG4 format. For reference, it has been reported in the literature that another IgG1 anti-CD47 antibody can cause more than a
40 percent decrease in RBCs at 1 mg/kg.</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD>After a single intravenous dose, ADG153-G1 demonstrated an approximately 8-fold longer apparent half-life and 5-fold higher area under
the curve (AUC) at 10mg/kg than Hu5F9.</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>Taken together, these preclinical findings suggest that the ADG153-G1 SAFEbody integrates safety (by precision masking) and efficacy
(by IgG1-mediated ADCC and ADCP) into one single modality for a best-in-class product profile, presenting the exciting opportunity <FONT STYLE="color: #333333; background-color: white">to
maximize potential </FONT>of anti-CD47 therapy - ultimately aimed for solid malignancies.</TD></TR></TABLE>

<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>ADG152 (CD20xCD3 POWERbody)</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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Key
findings from the poster (#1204) titled &ldquo;</FONT>ADG152, a Novel CD20xCD3 T-Cell Engager Prodrug with Enhanced Therapeutic Index,
Demonstrates Strong Anti-Tumor Activity with Improved Safety&rdquo; include:</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>ADG152 is a bispecific CD20xCD3 T-cell engager POWERbody that integrates SAFEbody precision masking technology to minimize cytokine
release syndrome (CRS) and on-target/off-tumor toxicities for an increased therapeutic index.</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">o</FONT></TD><TD>The anti-CD20 arm of ADG152 has enhanced the binding to CD20, while its anti-CD3 arm has tailor made affinity for CD3 using SAFEbody
technology.</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>At a 100-fold higher dose, ADG152 at 30 mg/kg resulted in significantly less cytokine induction (as measured by IFN-&gamma; and IL-2
levels) than an analog of plamotamab at 0.3 mg/kg.</TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD>In preclinical models, ADG152 resulted in dose-dependent anti-tumor activity with almost complete tumor growth inhibition when dosed
at 1.5 mg/<FONT STYLE="font-family: Times New Roman, Times, Serif">kg.</FONT></TD></TR></TABLE>

<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"><IMG SRC="tm2135240d1_ex99-1img001.jpg" ALT=""></P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD><FONT STYLE="font-family: Times New Roman, Times, Serif">ADG152 induced strong and sustained B-cell depletion across different dose
levels.</FONT></TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol; font-size: 10pt">&middot;</FONT></TD><TD><FONT STYLE="font-family: Times New Roman, Times, Serif">ADG152 also demonstrated improved </FONT>pharmacokinetics in monkeys versus
the plamotamab analog, with approximately a 2-fold longer half-life (7-13 days at 0.3 - 30mg/kg) and approximately an 8-fold higher AUC
after a single intravenous injection.</TD></TR></TABLE>

<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; font-size: 10pt">&ldquo;CRS
has been a longstanding challenge of T-cell engagers and has limited the ability to safely provide high levels of activity during initial
dosing,&rdquo; said Stanley Frankel, M.D., a clinical advisor who contributed to development and approval of </FONT><FONT STYLE="color: #333333">blinatumomab
(Blincyto&reg;) while working at Micromet and Amgen</FONT>. &ldquo;I am encouraged that the preclinical profile of ADG152 offers potential
to provide a way to simplify treatment by avoiding step dosing and pretreatment with steroids, while also enhancing efficacy of this POWERbody
to engage T-cells to attack tumor targets.&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"><FONT STYLE="font-size: 10pt">Both ADG153 and ADG152 are potential
Investigational New Drug candidates from Adagene&rsquo;s growing portfolio of preclinical discovery programs, five of which are in IND-enabling
studies.</FONT> The preclinical data presented at ASH provide a strong rationale for advancing these potentially best-in-class candidates
into clinical development.</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>About Adagene</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">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&trade;, SAFEbody<SUP>&reg;</SUP>, 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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
more information, please visit:&nbsp;</FONT><FONT><U>https://investor.adagene.com</U></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; background-color: white; color: #212121">SAFEbody<SUP>&reg;</SUP>
is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.</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>Safe Harbor Statement</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">This press release contains forward-looking statements, including statements
regarding the potential implications of preclinical results, and Adagene&rsquo;s advancement of, and anticipated clinical activities,
clinical development and regulatory milestones 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">&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"><IMG SRC="tm2135240d1_ex99-1img001.jpg" ALT=""></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; font-size: 10pt"><B>Internal
Contact</B></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">Ami Knoefler<BR>
Adagene<BR>
650-739-9952<BR>
<FONT><U>ir@adagene.com</U></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"><B>External Contact:</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">Bruce Mackle<BR>
LifeSci Advisors<BR>
646-889-1200<BR>
<FONT><U>bmackle@lifesciadvisors.com</U></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"></P>

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

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
