Bio-Thera Solutions has submitted a new drug application (NDA) with China's National Medical Products Administration (NMPA) for BAT5906, a self-developed anti-VEGF monoclonal antibody (mAb) for the treatment of neovascular (wet) age-related macular degeneration (nAMD/wAMD). This submission marks the first domestic filing for a Chinese-developed ophthalmic anti-VEGF mAb. BAT5906 is a full-length IgG1 antibody designed to bind specifically to VEGF-A165, inhibiting abnormal blood vessel growth in the eye.

The application is supported by positive results from a pivotal Phase III trial comparing BAT5906 to Lucentis (ranibizumab). The study met its primary endpoints, demonstrating that BAT5906 was superior to the control in reducing central retinal thickness (CRT) and resulted in a greater proportion of patients achieving a significant gain in best-corrected visual acuity (BCVA) over 52 weeks. The drug also features a potentially longer ocular half-life than ranibizumab, a fragment antibody, which may allow for less frequent dosing.

PharmCube's NextBiopharm® database shows that, if approved, BAT5906 will join with three other anti-VEGF mAbs launched to the global market, although only Novartis' ranibizumab and brolucizumab hold ophthalmic indications. Click here to request a free trial for NextBiopharm®.