百利天恒：公司自主研发的iza-bren的药品上市申请（NDA）已获得正式受理

Core Viewpoint - The company has received formal acceptance for the New Drug Application (NDA) of its first-in-class, new concept, and only EGFR×HER3 dual antibody ADC (iza-bren), which is currently in Phase III clinical trials for esophageal squamous cell carcinoma [1] Group 1 - The drug iza-bren has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial, as determined by an independent data monitoring committee (iDMC) [1] - The NDA acceptance is based on the interim analysis results from the Phase III clinical trial (study protocol number: BL-B01D1-305) [1] - The drug has been included in the priority review list by the Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1]