百利天恒(688506.SH)：iza-bren（EGFR×HER3 双抗ADC）用于治疗复发性或转移性食管鳞癌被纳入优先审评程序

Core Viewpoint - Baili Tianheng (688506.SH) announced that its self-developed first-in-class EGFR×HER3 dual antibody ADC (injectable iza-bren) has been included in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - Iza-bren is the world's first EGFR×HER3 dual antibody ADC to be included in the priority review list [1] - The proposed indication for iza-bren is for patients with recurrent or metastatic esophageal squamous cell carcinoma who have failed previous treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy [1] Group 2: Clinical Progress - As of now, iza-bren has been included in the breakthrough therapy list by the CDE for treating recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody therapy [1] - The interim analysis of the Phase III clinical trial for treating esophageal squamous cell carcinoma has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) [1] - Iza-bren has two indications that have been included in the priority review list by the CDE [1]