BIOKIN PHARMACEUTICAL(SH:688506) Ge Long Hui A P P·2025-11-18 00:41Core Insights - Baili Tianheng (688506.SH) announced that its self-developed first-in-class EGFR×HER3 bispecific antibody-drug conjugate (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] - The drug has been included in the breakthrough therapy list by the National Medical Products Administration (NMPA) in China, with plans for a pre-market communication application to be submitted soon, aiming for commercialization in the domestic market next year [2] Clinical Trial Results - The interim analysis of study BL-B01D1-305 showed that iza-bren demonstrated statistically significant benefits in PFS and OS compared to chemotherapy, indicating substantial clinical benefits [2] - In early clinical trials involving 82 ESCC patients, the overall response rate (ORR) was 32.9%, with a median PFS of 5.4 months and median OS of 11.5 months for the 2.5 mg/kg dose group [3][4] Safety Profile - Among the 82 patients analyzed for safety, the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 58.5%, with the most common being anemia (28.0%) and leukopenia (15.9%) [3][4] Market Potential - China accounts for 53.7% of global esophageal cancer patients, with a five-year survival rate of less than 6% for advanced ESCC, indicating a significant unmet clinical need [2] - The company aims to leverage its innovative drug development capabilities to address various cancers, including lung and breast cancers, with multiple new drug applications planned for submission [5][6][9] Company Strategy - Baili Tianheng focuses on addressing unmet clinical needs in the biopharmaceutical sector, particularly in tumor therapies, and aims to establish itself as a multinational pharmaceutical company by 2029 [5] - The company has established R&D centers in both the U.S. and China, developing a comprehensive platform for innovative drug research and development [5][6]