HLX04-O (Henlius)

HLX04-O (also known as EB12-20145P) is an investigational ophthalmic formulation of the bevacizumab biosimilar HLX04, jointly developed by Shanghai Henlius Biotech and Essex Bio-Technology. It is a recombinant humanized monoclonal antibody that specifically targets vascular endothelial growth factor A (VEGF-A). By binding to VEGF-A, HLX04-O inhibits its interaction with its receptors, VEGFR-1 (Flt-1) and VEGFR-2 (KDR), thereby suppressing downstream tyrosine kinase signaling pathways, endothelial cell proliferation, and pathological angiogenesis in the eye. HLX04-O has been optimized in its formulation, specifications, and manufacturing processes to meet the stringent requirements for ophthalmic administration. It is administered via intravitreal injection and is primarily being developed for the treatment of wet age-related macular degeneration (wAMD). Phase 3 clinical trials have demonstrated its non-inferiority to ranibizumab, and a New Drug Application (NDA) has been accepted for review in China.

Other names

recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injectionrecombinant anti-VEGF humanized monoclonal antibody ophthalmic injection