Core Viewpoint - The announcement indicates that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD) [1] Group 1: Clinical Study Results - The NDA submission is primarily based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection (IVT) of HLX04-O with ranibizumab for treating wAMD [1] - The study results show that the average change in best-corrected visual acuity (BCVA) from baseline at week 48 in the HLX04-O group was non-inferior to that of the ranibizumab group, achieving the primary endpoint of the study [1] - HLX04-O demonstrated good safety, with no new safety signals observed [1]
复宏汉霖：重组抗VEGF人源化单克隆抗体注射液HLX04-O 的上市注册申请获国家药监局受理