Drug intelligence / Profile preview

HLX04-O

Development stage
Phase 3
Lead developer
Henlius
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravitreal, Ophthalmic
01

Overview

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].

Brand names
HLX04-OHLX-04-OHLX 04-O
Other names
recombinant anti-VEGF humanized monoclonal antibody ophthalmic injectionbevacizumab biosimilar ophthalmic formulation
02

Targets

VEGFA (Vascular endothelial growth factor A)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR2 (Vascular endothelial growth factor receptor 2)

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