BIOKIN PHARMACEUTICAL(SH:688506) 智通财经网·2025-11-18 02:03Core Insights - Baillie Tianheng (688506.SH) announced that its self-developed, globally first and unique EGFR×HER3 dual antibody ADC (iza-bren) has achieved dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a Phase III clinical trial for esophageal squamous cell carcinoma (ESCC) [1][2] - This marks the first ADC drug to achieve positive PFS/OS results in the treatment of esophageal cancer in a Phase III clinical study [1] Group 1 - The independent data monitoring committee confirmed that iza-bren met the predefined interim analysis criteria for PFS and OS compared to chemotherapy [1] - The indication for iza-bren has been included in the breakthrough therapy list by the CDE, with a pre-market communication application submitted recently, expecting commercialization in China next year [1] Group 2 - In early clinical trials for advanced esophageal squamous cell carcinoma, iza-bren demonstrated excellent data, with an overall response rate (ORR) of 32.9% among 73 evaluable patients out of 82 [2] - Safety analysis indicated that the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 58.5%, with the most common being anemia (28.0%), leukopenia (15.9%), and thrombocytopenia and neutropenia (both 14.6%) [2] - Iza-bren has also met the standards in trials for nasopharyngeal carcinoma and plans to release data at ESMO 2025, with upcoming applications for lung cancer and breast cancer indications [2]