By Fineline Cube 
China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its Biologic License Application (BLA) for TAB014, a treatment for wet age-related macular degeneration (wAMD), has been accepted by China’s National Medical Products Administration (NMPA). This marks the first bevacizumab-based antibody product filed for wAMD treatment in China.
Clinical Trial Success
The BLA filing is supported by results from a completed Phase III study in China. This randomized, double-blinded, non-inferiority trial enrolled 488 patients across 57 centers, with Peking Union Medical College Hospital as the lead institution. The study demonstrated that TAB014 is non-inferior to the comparator drug Lucentis (ranibizumab) in improving visual acuity, meeting all primary and key secondary endpoints.
Product Details
TAB014 is a recombinant anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) administered via intravitreal injection. It works by inhibiting pathological angiogenesis in wAMD. The product has been included in China’s National Major New Drug Innovation Program and is manufactured in collaboration with Tot Biopharmaceutical International Co., Ltd (HKG: 1875).-Fineline Info & Tech