Workflow
重组抗VEGF人源化单克隆抗体
icon
Search documents
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
Core Viewpoint - The joint application for the market approval of HLX04-O, a recombinant anti-VEGF monoclonal antibody injection for the treatment of 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 [1][2][3] Group 1: Product Development - HLX04-O is developed using genetic engineering technology and specifically binds to VEGF, inhibiting its interaction with receptors on endothelial cells, thereby reducing neovascularization associated with wAMD [1] - 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 [2] - 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 [2] Group 2: Market Context - Currently, there are no approved bevacizumab formulations for ophthalmic diseases in China, making HLX04-O the second reported application for such a drug after TAB014 [3]