百利天恒(688506.SH)：iza-bren用于复发性或转移性食管鳞癌的III期临床试验的期中分析达到主要终点

Core Viewpoint - The company, Baillie Tianheng, announced that its self-developed first-in-class EGFR×HER3 dual antibody ADC (iza-bren) has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal squamous cell carcinoma [1] Group 1: Clinical Trial Results - The Phase III clinical trial (study protocol number: BL-B01D1-305) reached the predefined interim analysis, demonstrating positive results for both PFS and OS [1] - This marks the first ADC drug to achieve dual positive results in the treatment of esophageal cancer in a Phase III clinical study globally [1] Group 2: Drug Development and Regulatory Status - Iza-bren is the only EGFR×HER3 dual antibody ADC that has entered Phase III clinical trials and is being tested in over 40 clinical trials for various tumor types in China and the United States [1] - As of now, seven indications for iza-bren have been included in the breakthrough therapy designation list by the National Medical Products Administration in China, and one indication has been included by the U.S. Food and Drug Administration [1]