百奥泰：维拉西塔单抗注射液(BAT5906)上市许可申请获得受理

Core Viewpoint - The company Baiotai (688177.SH) has received a notice of acceptance from the National Medical Products Administration for its investigational drug, BAT5906, which is a monoclonal antibody injection aimed at treating diseases related to abnormal blood vessel growth [1] Group 1: Drug Information - BAT5906 is a recombinant humanized monoclonal antibody, classified as a Class 1 therapeutic biological product [1] - The drug specifically binds to human VEGF-A165, inhibiting neovascularization [1] - In vitro models show that BAT5906 can block the binding of VEGF to its receptors, suppressing endothelial cell proliferation and new blood vessel formation [1] Group 2: Safety and Efficacy - In animal studies, BAT5906 demonstrated a longer half-life in the vitreous of monkeys compared to the Fab fragment structure of Ranibizumab, potentially allowing for longer injection intervals in clinical use [1] - The drug does not trigger antibody-dependent cell-mediated cytotoxicity (ADCC), suggesting a lower incidence of systemic adverse reactions and potentially safer clinical applications [1] Group 3: Regulatory Status - Upon approval, BAT5906 will receive a drug approval certificate and can be produced and marketed [1] - The timeline for the review and approval process is uncertain, indicating that the acceptance notice will not impact the company's short-term performance [1]