Adagene Announces Clinical Trial Collaboration to Evaluate Anti-CTLA-4 SAFEbody ADG126 in Combination with Roche's Standard-of-Care for First-Line Advanced Liver Cancer SAN DIEGO and

Announces Clinical Trial Collaboration to Evaluate Anti-CTLA-4 SAFEbody ADG126 in Combination with Roche's Standard-of-Care

for First-Line Advanced Liver Cancer

SAN DIEGO and SUZHOU, China, December 16, 2022 -

Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of antibody-based

therapies, today announced a clinical trial collaboration with Roche to

evaluate the triple combination of Adagene's ADG126 with Roche's atezolizumab and bevacizumab in first-line

treatment of advanced hepatocellular carcinoma (HCC; liver cancer). The collaboration will utilize Roche's MORPHEUS-LIVER

platform for rapid and efficient combination development.

the collaboration, Roche will sponsor and conduct a randomized phase 1b/2 multi-national trial to evaluate the efficacy, safety and

pharmacokinetics of ADG126 in combination with bevacizumab and atezolizumab, versus

atezolizumab and bevacizumab alone, initially in 60 patients. Each company is supplying its respective anti-cancer agent(s) to

support the trial. Adagene will retain global development and commercialization rights to ADG126. Additional financial details of

the collaboration were not disclosed.

This study expands Adagene's global

clinical development program for ADG126 into a new setting and tumor type as a potential component of first-line combination therapy for

HCC, where current anti-CTLA-4 therapy has demonstrated statistically significant clinical benefit in combination with anti-PD-1/PD-L1

treatment. Results of ongoing phase 1b/2 clinical trials have demonstrated a compelling, differentiated safety profile for ADG126 at doses

up to 20 mg/kg with repeat dosing as monotherapy and up to 10 mg/kg in combination with anti-PD-1 therapy. With its unprecedented safety

profile, encouraging anti-tumor activity and ability for repeat dosing, ADG126 is well suited as a combination agent designed to improve

"We are excited to initiate this collaboration

with Roche and explore the potential of ADG126 as a key component of a triplet combination for treating first-line liver cancer, along

with an established standard-of-care doublet pioneered by Roche," said Peter Luo, Ph.D., Co-founder and CEO of Adagene. "Given

the longstanding safety challenges of combining multiple therapies in this cancer type, we are very excited to bring forth a potential

anti-CTLA-4 treatment with an unprecedented safety profile in an immunotherapy-based triplet combination as a promising strategy

to treat liver cancer patients, where two first-line therapies have already received FDA approval."

technology is designed to address safety and tolerability challenges of many

antibody therapeutics by minimizing on-target off-tumor toxicity in healthy tissues. ADG126 SAFEbody applies this precision-masking technology

to the parental anti-CTLA-4 antibody, ADG116, for conditional activation in the tumor microenvironment (TME) to expand the therapeutic

index and further address safety concerns with existing anti-CTLA-4 therapies.

to the same distinct and highly conserved epitope as ADG116, the masked ADG126 is designed to provide enhanced safety and efficacy profiles

due to the combination of the potent Treg depletion in the TME and partial ligand blocking by the activated ADG126, which is accumulated

steadily for the prolonged tumor killing effect.

About Hepatocellular Carcinoma

Liver cancer is the fifth most common cancer and the second most frequent

cause of cancer-related death globally, with 854,000 new cases and 810,000 deaths per year. Hepatocellular carcinoma (HCC) is the

most prevalent form of primary liver cancer and represents approximately 90% of all primary hepatic malignancies. Up to 80% of patients

first presenting with HCC have advanced unresectable or metastatic disease because of the late appearance of symptoms. It is a medically

complex and difficult-to-treat disease as the majority of patients with HCC have underlying cirrhosis requiring management of both the

malignancy and the cirrhosis. In the United States, the 5-year overall survival (OS) rate of patients with HCC is 17% (Siegel et

al. 2016, while in China, the 5-year OS rate of patients with HCC is 10.1% (Chen et al. 2016). HCC is a highly lethal

disease with the highest mortality-to-incidence rate ratio of 0.98 of any solid tumor (Kamangar et al. 2006). The WHO estimates that more

than 1 million people will die from liver cancer in 2030, highlighting a significant global public health issue (Villanueva 2019).

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology 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.

information, please visit: https://investor.adagene.com. Follow Adagene on WeChat, LinkedIn and Twitter.

SAFEbody is a registered trademark in the

United States, China, Australia, Japan, Singapore, and the European Union.

Adagene Safe Harbor Statement

This press release contains forward-looking statements within the meaning

of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential implications of clinical data for

patients, and Adagene's advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and

commercialization of its product candidates, including ADG126, the anticipated benefits and potential of Adagene's collaboration

arrangement with Roche. 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 annual report for the year of 2021 on Form 20-F filed 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