Core Viewpoint - The company, Fuhong Hanlin (02696), has received acceptance for its New Drug Application (NDA) for HLX04-O, a treatment for wet age-related macular degeneration (wAMD), from the National Medical Products Administration (NMPA) [1] Group 1 - The NDA for HLX04-O is 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 indicate that the average change in Best Corrected Visual Acuity (BCVA) at week 48 for the HLX04-O group was non-inferior to that of the Ranibizumab group, achieving the primary endpoint of the study [1] - The safety profile of HLX04-O is favorable, with no new safety signals observed [1]
复宏汉霖(02696)：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