Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for treating wet age-related macular degeneration (wAMD), has been submitted by Fuhong Hanlin and Edding Bio, marking the second such application for a bevacizumab ophthalmic formulation in China [2][4]. Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, blocking its interaction with receptors on endothelial cells, thereby inhibiting endothelial cell proliferation and reducing neovascularization [2]. - The drug has successfully met the primary endpoint in a Phase III clinical trial (NCT05003245) comparing its efficacy and safety against ranibizumab in wAMD patients, showing non-inferiority in terms of best-corrected visual acuity improvement [3]. - An international multi-center Phase III clinical study (NCT04740671) is also being conducted for HLX04-O, with participants recruited from China, Australia, the EU, and the US [3]. Group 2: Market Context - Currently, there are no approved bevacizumab formulations for treating ophthalmic diseases in China, making HLX04-O a significant addition to the market [4]. - The only other application for a bevacizumab ophthalmic formulation, TAB014, was submitted by Zhaoke Ophthalmology and Dongyao Pharmaceutical in June 2023 for the treatment of wAMD [4].
国内第2款！复宏汉霖和亿胜生物“贝伐珠单抗”眼科制剂申报上市