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HLX04-O is a recombinant anti–vascular endothelial growth factor (VEGF) humanized monoclonal antibody injection developed specifically for ophthalmic use. It is an optimized formulation of the bevacizumab biosimilar HLX04, designed for intravitreal administration to treat eye diseases associated with pathological angiogenesis, such as wet age-related macular degeneration (wAMD). The drug works by inhibiting VEGF’s binding to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on endothelial cells, thereby blocking activation of downstream tyrosine kinase signaling pathways, suppressing endothelial cell proliferation, and reducing abnormal blood vessel formation in the retina. Developed by Henlius in collaboration with Essex Bio-Technology, HLX04-O has demonstrated non-inferior efficacy and a favorable safety profile compared to ranibizumab in phase 3 clinical trials for wAMD. It is expected to become one of the first bevacizumab-based therapies approved specifically for ophthalmic indications[1][2][3][5][6][7][8].
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