Core Viewpoint - The company Fuhong Hanlin (复宏汉霖) announced that its HLX04-O injection has met the primary endpoint in a Phase III clinical study for wet age-related macular degeneration (wAMD) in Chinese patients [1][2]. Group 1: Clinical Study Details - The study was a multicenter, randomized, double-blind, positive-controlled non-inferiority trial comparing HLX04-O with Ranibizumab (雷珠单抗) in wAMD patients [2]. - Patients were randomly assigned in a 1:1 ratio to receive either HLX04-O (1.25 mg) or Ranibizumab (0.5 mg) via intravitreal injection every four weeks for one year, with the primary endpoint being the change in best-corrected visual acuity (BCVA) from baseline at week 48 [2]. - Results showed that the average letter score improvement in the HLX04-O group at week 48 was non-inferior to that of the Ranibizumab group, achieving the primary endpoint [2]. Group 2: Product Development and Market Potential - HLX04-O is developed based on the company's existing product Hanbeitai (汉贝泰, Bevacizumab injection), optimized for ophthalmic use while maintaining the active ingredient [3]. - In addition to the successful Phase III study, international multicenter Phase III trials for HLX04-O are ongoing in several European countries, Australia, the United States, and mainland China [3]. - As of the announcement date, there are no Bevacizumab products approved for wAMD in mainland China, and the projected sales for wAMD treatments in China for 2024 are approximately RMB 4.18 billion [3].
复宏汉霖(02696)：重组抗VEGF人源化单克隆抗体注射液HLX04-O 用于湿性年龄相关性黄斑变性(wAMD)治疗的3期临床研究达到主要研究终点