百利天恒ADC药物治疗晚期食管鳞癌三期临床试验期中分析达到主要终点,或明年商业化落地

Core Viewpoint - Baili Tianheng (688506.SH) announced that its self-developed, globally pioneering EGFR×HER3 dual-targeted 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 (ESCC) [1] Group 1: Clinical Trial Results - The independent data monitoring committee (iDMC) determined that the drug met the predefined interim analysis criteria for both PFS and OS [1] - This marks the first ADC drug to achieve positive results for both PFS and OS in a Phase III clinical study for esophageal cancer [1] Group 2: Market Potential - China accounts for 53.7% of global esophageal cancer patients, with a five-year survival rate of less than 6% for advanced ESCC patients, indicating a significant clinical need [1] - The indication has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) [1] Group 3: Future Plans - Baili Tianheng plans to submit a pre-market communication application to the NMPA soon, with expectations for commercialization in China next year [1]