Core Insights - The National Medical Products Administration (NMPA) has accepted a new drug application for the first-in-class dual antibody ADC drug, iza-bren, developed by BaiLi Tianheng, aimed at treating recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after failure of PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1][2] - The application is based on positive results from a Phase III clinical trial, which met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in a pre-specified interim analysis [1] - Esophageal cancer has a significant global burden, with approximately 510,000 new cases and 445,000 deaths annually, and China accounts for about 224,000 new cases, representing 43.8% of the global total [1] Group 1 - Iza-bren has shown anti-tumor activity, safety, and efficacy in a Phase Ib clinical study published in the journal Nature Medicine [2] - Currently, over 40 clinical studies are ongoing for iza-bren in China and the U.S., including 10 registration Phase III studies in China and 3 global pivotal registration studies [2] - Seven indications for iza-bren have been included in the breakthrough therapy designation list by the CDE, and one indication has been designated as breakthrough therapy by the FDA [2] Group 2 - There are currently only 10 new biological drugs approved for esophageal cancer treatment globally, with no ADCs approved yet [3] - If approved, BL-B01D1 will become the first ADC drug for the treatment of esophageal cancer worldwide [3]