Bio-Thera Solutions,Ltd. (688177.SH) announced that the company has recently received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration for its investigational drug, recombinant humanized anti-VEGF monoclonal antibody injection (BAT5906), for additional indications including macular edema caused by central retinal vein occlusion (CRVO-ME) and choroidal neovascularization in pathological myopia (pmCNV).
According to the announcement, BAT5906 is an innovative recombinant humanized monoclonal antibody drug independently developed and produced by Bio-Thera Solutions,Ltd. It is a full-length IgG1 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 receptors, inhibiting endothelial cell proliferation and neovascularization.
In animal studies, BAT5906 demonstrated a longer serum half-life compared to ranibizumab, which has a Fab fragment structure, potentially supporting longer injection intervals in clinical applications. Regarding drug safety, BAT5906 does not trigger antibody-dependent cell-mediated cytotoxicity (ADCC), resulting in minimal systemic adverse reactions and potentially safer clinical applications.
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