Adagene Inc. announced that China’s National Medical Products Administration (NMPA) cleared its Investigational New Drug (IND) application for ADG138, a novel HER2xCD3 double-masked bispecific T-cell engager utilizing the company's proprietary SAFEbody® technology. The clearance enables Adagene to initiate a first-in-human Phase 1 clinical study evaluating safety and preliminary efficacy in patients with advanced solid tumors, expected to begin in the fourth quarter of 2026. Preclinical data indicated robust tumor regression in models resistant to Enhertu (DS-8201) and strong synergy with anti-PD-1 or anti-CTLA-4 antibodies. Adagene Inc. is a clinical-stage biotechnology company focused on discovering and developing novel antibody-based cancer immunotherapies.
