Bio-Thera(SH:688177) Zheng Quan Zhi Xing·2025-08-01 16:13Core Viewpoint - Baiotai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of its recombinant humanized monoclonal antibody injection BAT5906, targeting retinal central vein occlusion-related macular edema (CRVO-ME) and pathological myopia-related choroidal neovascularization (pmCNV) [1] Group 1: Drug Approval Details - The drug name is recombinant humanized monoclonal antibody injection, classified as a type 1 drug, with a specification of 16mg/0.2ml [1] - The clinical trial application was accepted on May 8, 2025, and has met the requirements for drug registration [1] Group 2: Drug Characteristics - BAT5906 is an innovative drug developed by Baiotai, an IgG1 full-length antibody with a molecular weight of 149KDa, specifically binding to human VEGF-A165 to inhibit neovascularization [2] - In vitro models show that BAT5906 can block the binding of VEGF to its receptors, inhibiting endothelial cell proliferation and neovascular formation [2] - The serum half-life of BAT5906 is longer than that of the Fab fragment-based drug Ranibizumab, potentially allowing for longer injection intervals [2] - The drug does not trigger antibody-dependent cell-mediated cytotoxicity (ADCC), suggesting a lower incidence of systemic adverse reactions and potentially safer clinical applications [2] Group 3: Clinical Trial Status - As of the announcement date, BAT5906 has received approval for clinical trials for several indications: wet age-related macular degeneration (w-AMD), diabetic macular edema (DME), CRVO-ME, and pmCNV [3] - The company has completed Phase I, II, and III clinical studies for w-AMD, while Phase II for DME is complete and Phase III is in the final stages of patient recruitment [3] - Clinical research for CRVO-ME and pmCNV is in the preparation stage for Phase II/III trials [3]