百利天恒:公司自主研发的iza-bren的药品上市申请已获得正式受理
Jin Rong Jie·2026-01-20 10:35

Core Viewpoint - The company has received formal acceptance for the New Drug Application (NDA) of its self-developed, globally innovative EGFR×HER3 dual antibody ADC, which is the only one to enter Phase III clinical trials [1] Group 1 - The drug, named iza-bren, has achieved dual primary endpoints of progression-free survival and overall survival in a Phase III clinical trial for esophageal squamous cell carcinoma, as determined by an independent data monitoring committee during a pre-set interim analysis [1] - The NDA acceptance is based on the interim analysis results from the Phase III clinical trial [1] - Iza-bren 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]

BIOKIN PHARMACEUTICAL-百利天恒:公司自主研发的iza-bren的药品上市申请已获得正式受理 - Reportify