Adagene Announces Multi-Target Collaboration with Sanofi to Develop Next-Generation Masked Antibody Candidates Using SAFEbody® Technology

SUZHOU, China and SAN DIEGO, March 3, 2022 -- Adagene Inc. (“Adagene” or the “Company”) (NASDAQ: ADAG) is a platform-driven, clinical-stage biopharmaceutical company dedicated to discovering and developing novel cancer immunotherapies based on original antibodies.The company announced today that it has entered into a research collaboration and exclusive technology license agreement with Sanofi. Adagene will lead early-stage R&D activities, leveraging its proprietary SAFEbody® technology to develop precisely masked safe antibodies based on next-generation monoclonal and bispecific antibodies provided by Sanofi, while Sanofi will be responsible for subsequent further R&D, product development, and commercialization activities.

Sanofi will pay Adagene a $17.5 million upfront payment to initiate the collaborative development of two antibody candidates provided by Sanofi, with the option to nominate two additional candidate antibodies for development and commercialization. Furthermore, for products exclusively developed and commercialized by Sanofi in the future, Adagene will be eligible to receive up to $2.5 billion in development, regulatory, and commercial milestone payments, as well as tiered royalties on global net sales of the products.

“We look forward to collaborating with Adagene to design and develop original antibody drugs, fulfilling our mission of pursuing scientific miracles and bringing transformative new medicines to cancer patients.”Valeria Fantin, Global Head of Oncology R&D at Sanofistated, “For pathways that have been extensively explored yet whose tumor mechanisms remain unclear, Adagene’s unique antibody platform will enable us to precisely target those well-established but poorly addressed tumor mechanisms with best-in-class therapeutics.”

“The core technology of Adagene’s SAFEbody® safety antibody has been extensively validated by substantial preclinical and clinical data for ADG126 (an anti-CTLA-4 safety antibody). We are delighted to collaborate closely with Sanofi, leveraging our precision masking safety antibody technology to empower the development of novel therapeutics targeting multiple highly promising yet challenging oncology immunotherapy targets.”Dr. Peizhi Luo, Co-Founder, Chief Executive Officer, and Chairman of Adagene“By leveraging our artificial intelligence technology platform, we are at the forefront of global antibody discovery and drug development. This enables our antibody-based therapies to achieve dynamic and precise target engagement, tailored specifically to overcome the fundamental challenges in today’s oncology drug development.”

By employing precise masking technology to cover the antigen-binding domains of antibodies, Adagene’s SAFEbody® technology addresses the safety and tolerability issues prevalent in many antibody therapies. Through specific activation within the tumor microenvironment, SAFEbody® antibodies achieve precisely targeted tumor suppression in tumor tissues while minimizing toxic side effects on surrounding healthy tissues. The SAFEbody® technology is broadly applicable across multiple antibody formats, including monoclonal and bispecific antibodies, such as Fc receptor-engaging antibodies, antibody-drug conjugates (ADCs), and T-cell engagers.

In addition to its existing global business collaborations, Adagene is building a highly differentiated and transformative pipeline of antibody-based therapies. Currently, five products developed by Adagene have entered clinical development, all generated using Adagene’s AI-powered antibody technology platform. These include three wholly owned products in Phase 1b/2 clinical development and two out-licensed candidate products (for the Greater China region). Furthermore, Adagene has five projects in the IND-enabling stage, with more than 50 additional drug candidates at various stages of research.

Adagene Inc. (NASDAQ: ADAG) is a platform-driven biopharmaceutical company with clinical-stage product candidates derived from its proprietary platforms, dedicated to discovering and developing novel cancer immunotherapies based on original antibodies. Leveraging computational biology and artificial intelligence, and powered by its first-in-class Tri-Body platform technologies—NEObody™ (neoepitope antibody), SAFEbody® (safety antibody), and POWERbody™ (potency antibody)—Adagene has established a unique and original antibody pipeline focused on novel tumor immunotherapies to address unmet clinical needs. Adagene has formed strategic collaborations with multiple globally renowned partners, empowering their new drug development with its diverse portfolio of original cutting-edge technologies.

For more information, please visit https://investor.adagene.com and follow Adagene’s official WeChat, LinkedIn, and Twitter accounts.

SAFEbody® is a registered trademark of Adagene in the United States, China, Australia, Japan, Singapore, and the European Union.

This press release contains forward-looking statements, including: statements described in this press release regarding the expected effects of the license and collaboration with Sanofi; the plan that Sanofi shall be solely and fully responsible for all subsequent clinical, regulatory, commercial, and manufacturing activities related to Sanofi’s masked antibody candidate; the upfront payment received by Adagene; potential revenue for Adagene from development and commercialization milestones, as well as royalties on sales of any commercialized products under the collaboration; and Adagene’s expectations regarding preclinical studies, clinical activities, clinical development, regulatory milestones, and commercial advancement for its candidate products. Due to the impact of various important factors, actual results may differ materially from those indicated in the forward-looking statements, including but not limited to: Adagene’s ability to demonstrate the safety and efficacy of its candidate drugs; clinical results of its candidate drugs, which may not support further development or regulatory approval; the content and timing of decisions by relevant regulatory authorities regarding regulatory approval of Adagene’s candidate drugs; if approved, Adagene’s ability to achieve commercial success for its candidate drugs; Adagene’s ability to obtain and maintain intellectual property protection for its technologies and drugs; Adagene’s reliance on third parties for drug development, manufacturing, and other services; Adagene’s limited operating history and its ability to obtain additional funding for operations and to complete the development and commercialization of its candidate drugs; Adagene’s ability to enter into additional cooperation agreements beyond its existing strategic partnerships or collaborations; the impact of COVID-19 on Adagene’s clinical development, commercialization, and other operations; and those risks more fully discussed in the “Risk Factors” section of Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and unless required by law, Adagene assumes no obligation to publicly update or revise any forward-looking statements due to new information, future events, or other reasons.