Core Insights - BaiLi TianHeng announced the successful interim analysis of its first-in-class EGFR×HER3 dual antibody ADC (iza-bren) in a Phase III clinical trial for esophageal squamous cell carcinoma, achieving both progression-free survival (PFS) and overall survival (OS) primary endpoints [1][2] - The drug has been included in the breakthrough therapy list by the National Medical Products Administration (NMPA) and is expected to submit a pre-market communication application soon, with commercialization anticipated in the domestic market next year [2] Group 1 - The interim analysis of study BL-B01D1-305 showed that iza-bren demonstrated statistically significant benefits in PFS and OS compared to chemotherapy, indicating major clinical benefits [2] - This marks the first ADC drug to achieve dual positive results in a Phase III clinical study for esophageal cancer treatment [1] - Iza-bren has previously shown excellent data in early clinical trials for advanced esophageal squamous cell carcinoma and has been published in the prestigious journal Nature Medicine [2] Group 2 - BaiLi TianHeng focuses on addressing unmet clinical needs in the global biopharmaceutical frontier, particularly in the field of tumor macromolecule therapy, and aims to become a multinational pharmaceutical company (MNC) with global commercialization capabilities by 2029 [3] - The company has established R&D centers in both the US and China, responsible for early product development and subsequent clinical research [3] - BaiLi TianHeng has developed a leading innovative drug R&D platform with global rights and independent intellectual property, including the HIRE-ADC platform, GNC platform, SEBA platform, and HIRE-ARC platform [3]