Adagene Presents Clinical Data Demonstrating Strong Safety and Early Signals of Efficacy in Cold Tumors Including Pancreatic and Ovarian Cancers for Anti-CTLA-4 Monoclonal Antibody, ADG116, at ESMO-IO 2021 - Additional h

Adagene Presents Clinical Data Demonstrating

Strong Safety and Early Signals of Efficacy in Cold Tumors Including Pancreatic and Ovarian Cancers for Anti-CTLA-4 Monoclonal Antibody,

ADG116, at ESMO-IO 2021

- Additional highlights include pharmacodynamic

biomarker analyses from ongoing trial of anti-CD137 antibody, ADG106, in combination with anti-PD-1 toripalimab -

SAN DIEGO and SUZHOU, China, December 6, 2021 - Adagene

Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the

discovery and development of novel antibody-based immunotherapies, today announced clinical data on its anti-CTLA-4 monoclonal antibody,

ADG116, and anti-CD137 agonist, ADG106, in two poster presentations at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO)

Congress 2021, to be held virtually and in Geneva, Switzerland from December 8 to 11, 2021. Both posters are available in the Publications

section of the company's website at www.adagene.com.

In the first presentation of results from an ongoing dose-escalation

trial of monotherapy in patients with advanced metastatic tumors, ADG116 demonstrated a strong safety profile and early signals of efficacy,

including dose-dependent T-cell activation and tumor suppression in treatment-resistant "cold" and "warm" tumors

such as pancreatic, ovarian and renal cell cancers.

Commenting on the findings, Dr. Gary Richardson, OAM, MBBS, FRACP,

Group Director at Cabrini Health Research, Director at Szalmuk Family Department of Medical Oncology and Professor of Medicine at Monash

University, Australia, "These encouraging clinical data demonstrate the promising safety profile of ADG116 monotherapy in patients

with advanced solid tumors across 15 different tumor types, the majority of which are resistant to standard therapy. The most exciting

thing about these results is that we have also seen the early signals of efficacy in cold' tumors such as pancreatic and

certain gynecological cancers, which do not respond to current immunotherapies. We want to see this type of unique activity, which suggests

that this treatment may look different and potentially better than the options we have available today."

Additionally, a separate poster presentation describing results of

pharmacodynamic (PD) biomarker analyses reinforced the synergy and strong T-cell activation of ADG106 in combination with the anti-PD-1

antibody toripalimab.

A summary of data from both posters is included below.

Key findings from the poster (#137P) titled "Phase 1 dose-finding

study of a novel anti-CTLA-4 antibody ADG116 as monotherapy in patients with advanced solid tumors" include:

The findings support that ADG116 has achieved the recommended dosing

range as a single agent and for evaluation in combination therapy. The ADG116-1003 trial continues with dose escalation at 10 mg/kg, while

cohort expansion has been initiated at 6 mg/kg.

Adagene is also advancing ADG116 in combination with anti-PD-1 therapy

(pembrolizumab or toripalimab) and with its proprietary anti-CD137 agonist (ADG106). Further, the

company is evaluating a second anti-CTLA-4 antibody, ADG126, using its SAFEbody precision masking technology in an ongoing phase

1 dose escalation as monotherapy. This reflects the company's commitment to unlock the value of CTLA-4 as a proven target and the

backbone of future immunotherapies.

Key findings from the poster (#43P) titled "Assessment of Biomarker

Kinetics for ADG106 (anti-CD137 agonist) as monotherapy or combined with toripalimab" include:

These findings highlight the synergistic activity of ADG106 in combination

with the anti-PD-1 toripalimab for patients who failed anti-PD-1 and anti-CTLA-4 immunotherapies. This combination is being evaluated

in the ongoing ADG106-1008 clinical trial, currently in a cohort dosing ADG106 at 3 mg/kg. The data support further exploration of combination

therapy regimens with ADG106 at informed dose ranges for targeting biomarker enriched tumor types.

"The data presented today from two of our NEObody clinical

programs show how we are creating transformative antibody-based immunotherapies that push the limits of antibody discovery and development,

overcoming liabilities with some of the most promising yet challenging immuno-oncology

targets today," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "These findings

strengthen confidence in our clinical pipeline and in the ability of our platform technologies to achieve unprecedented results that will

ultimately benefit patient care."

This NEObody program, targeting

a unique epitope of CTLA-4, is being evaluated in patients with advanced/metastatic solid tumors. ADG116 is designed to enhance efficacy

by potent Treg depletion in the tumor microenvironment (TME) and maintain its physiological function by soft ligand blocking to address

safety concerns associated with existing CTLA-4 therapeutics.

This NEObody program is a fully

human ligand-blocking, agonistic anti-CD137 IgG4 monoclonal antibody (mAb) that is being evaluated in patients with advanced solid tumors

and/or non-Hodgkin's lymphoma.

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 , and POWERbody technologies, Adagene'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.

For more information, please visit: https://investor.adagene.com.

Safe Harbor Statement

This press release contains forward-looking statements, including statements

regarding the potential implications of clinical data for patients, and Adagene'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'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's drug candidates; Adagene's ability to achieve commercial success for its drug candidates,

if approved; Adagene's ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene's

reliance on third parties to conduct drug development, manufacturing and other services; Adagene's limited operating history and

Adagene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug

candidates; Adagene'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's clinical development, commercial and other operations, as well as those risks

more fully discussed in the "Risk Factors" section in Adagene'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