Henlius HLX04-O meets endpoint in macular degeneration trial

Shanghai Henlius Biotech, Inc. (HKEX:2696) announced that its Phase 3 clinical study of HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody injection, met its primary endpoint for treating wet age-related macular degeneration (wAMD) in Chinese patients. The multi-center, randomized, double-blind trial compared HLX04-O to ranibizumab and found HLX04-O to be non-inferior in improving visual acuity at week 48. The drug also demonstrated a good safety profile comparable to ranibizumab. Henlius noted that an international Phase 3 study of HLX04-O is ongoing in other regions, and a Phase 1/2 study has previously shown safety and tolerability. As of the announcement, no bevacizumab product has been approved in mainland China for wAMD treatment. According to IQVIA, drugs approved in mainland China for wAMD treatment had sales of approximately RMB4.18 billion in 2024.