BIOKIN PHARMACEUTICAL(SH:688506) Zhi Tong Cai Jing·2025-11-18 00:47Core Insights - Baili Tianheng (688506.SH) announced that its self-developed, globally first and only EGFR×HER3 dual-targeted 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] - The trial specifically targets patients with recurrent or metastatic ESCC who have previously failed PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] - The drug has been included in the breakthrough therapy list by the CDE, and the company has submitted a pre-market communication application, expecting commercialization in China next year [1] Clinical Trial Results - The interim analysis of the BL-B01D1-305 study showed that iza-bren achieved both PFS and OS endpoints compared to chemotherapy [1] - In early clinical trials involving 82 ESCC patients, the overall objective response rate (ORR) was 32.9%, with 73 patients eligible for efficacy evaluation [2] - The 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] Future Developments - The treatment for nasopharyngeal carcinoma has also met its trial goals, with plans to present data at ESMO 2025 [2] - The company is preparing to apply for market approval for indications in nasopharyngeal carcinoma and esophageal squamous cell carcinoma, with additional applications for lung cancer and breast cancer expected to follow [2]