Bio-Thera Solutions (688177.SH): The application for marketing authorization of the injection of Virexital monoclonal antibody (BAT5906) has been accepted.

Bio-Thera Solutions (688177.SH) announced that it has recently received a "Notice of Acceptance" from the National Medical Products Administration regarding the company's application for the market approval of its investigational drug Vilseta Monoclonal Antibody Injection (referred to as "BAT5906"). BAT5906 is a recombinant humanized monoclonal antibody innovative drug developed and produced by Bio-Thera Solutions. It is an IgG1 full-length antibody with a molecular weight of 149KDa, capable of specifically binding to human VEGF-A165 and inhibiting angiogenesis. In in vitro angiogenesis models, BAT5906 can block the binding of VEGF to its corresponding receptor, inhibiting endothelial cell proliferation and neovascular formation. In animal experiments, BAT5906 has a longer half-life in the monkey vitreous than the structure of Fab fragments of ranibizumab, potentially supporting a longer injection cycle in clinical use. In terms of safety, it does not trigger antibody-dependent cell-mediated cytotoxicity (ADCC), resulting in minimal systemic adverse reactions, making it potentially safer for clinical application.