Phase 1 study with ADG138 for patients with advanced solid tumors is expected to begin in China in the fourth quarter of 2026

ADG138 is a double-masked T-cell engager, applying Adagene’s proprietary SAFEbody® precision masking technology on both HER2 and CD3 binding sites to enable tumor-selective therapy with low systemic toxicity

Preclinical data demonstrated robust tumor regression in tumor models refractory and/or resistant to Enhertu, along with strong synergy in combination with anti-CTLA-4, anti-PD-1 or anti-CD137 antibodies

SAN DIEGO and SUZHOU, China, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced that China’s National Medical Products Administration (NMPA) has approved the company’s investigational new drug (IND) application for ADG138, a double-masked HER2×CD3 bispecific T cell engager built on Adagene’s proprietary SAFEbody® precision masking technology. Adagene expects to initiate a first-in-human Phase 1 study of ADG138 for the treatment of advanced solid tumors in the fourth quarter of 2026.