BIOKIN PHARMACEUTICAL(SH:688506) Zheng Quan Shi Bao Wang·2026-01-20 10:25Core Viewpoint - The company Baili Tianheng (688506) has received a formal acceptance notice from the National Medical Products Administration (NMPA) for its drug application of the EGFR×HER3 dual antibody ADC (iza-bren), indicating progress towards market approval [1] Group 1: Drug Development and Approval - The drug application (NDA) for iza-bren has been officially accepted based on the interim analysis results from a Phase III clinical trial for esophageal squamous cell carcinoma [1] - The independent data monitoring committee (iDMC) determined that the trial met its primary endpoints of progression-free survival (PFS) and overall survival (OS) during the pre-specified interim analysis [1] - Iza-bren has been included in the priority review list by the NMPA for the treatment of recurrent or metastatic esophageal squamous cell carcinoma [1]