百利天恒iza-bren用于治疗复发性或转移性食管鳞癌的药品上市申请获得受理

Core Viewpoint - The company, Bai Li Tian Heng, has received formal acceptance of its New Drug Application (NDA) for its innovative EGFR×HER3 dual antibody ADC (iza-bren), marking a significant milestone in the treatment of recurrent or metastatic esophageal squamous cell carcinoma that has failed previous PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy [1] Group 1 - The drug is the world's first-in-class and is currently the only one in Phase III clinical trials [1] - The acceptance of the NDA was granted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration [1] - The drug is specifically designed for patients who have previously undergone treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy [1]