Core Viewpoint - 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) by the company [1] Company Summary - HLX04-O's NDA is based on a multicenter, randomized, double-blind, positive-controlled Phase III study comparing intravitreal injection 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 [1] - HLX04-O demonstrated good safety, with no new safety signals observed [1] Industry Summary - As of the announcement date, there are no approved products for wAMD in China that are based on bevacizumab [1] - According to the latest data from IQVIA CHPA, the sales revenue for drugs targeting wAMD in China is projected to be approximately RMB 4.9 billion in 2024 [1]