June 16, 2026 — Henlius (HKEX: 2696) today announced that the international multicentre phase 3 clinical trial of HLX04-O (NCT04740671), a recombinant anti-vascular endothelial growth factor (VEGF) humanised monoclonal antibody injection, for the treatment of wet age-related macular degeneration (wAMD), has successfully met its pre-specified primary endpoint. Together with the Phase 3 clinical study conducted in China (NCT05003245), these results will constitute a pivotal data package to support the Company’s partner in advancing marketing authorisation applications in overseas markets, including the United States. Previously, the new drug application (NDA) for HLX04-O in wAMD has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
HLX04-O is a novel ophthalmic formulation developed by Henlius to address specific clinical needs in ophthalmology. According to the requirements of ophthalmic drugs, the company has developed HLX04-O which optimizes the prescription, specifications, and production processes of HANBEITAI, assuming that the active ingredients remain unchanged. Developed using genetic engineering technology, HLX04-O specifically binds to VEGF and blocks its interaction with endothelial cell receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2), thereby inhibiting downstream tyrosine kinase signalling pathways. This mechanism inhibits endothelial cell proliferation and pathological neovascularisation, enabling the treatment of eye diseases associated with angiogenesis such as wAMD. Through a series of comparability analysis, it is proved that the changes in the production process and prescription of the preparation have no adverse impact on the quality, safety and efficacy of the preparation. As of now, none of the bevacizumab products marketed in Chinese mainland has been approved for the treatment of wAMD.
NCT04740671 is a global, multi-centre, randomized, double-blind, active-controlled, non-inferiority phase 3 clinical trial aimed to compare the efficacy and safety of HLX04-O with ranibizumab administered by intravitreal injection (“IVT”) in wet age-related macular degeneration (wAMD) patients. Patients enrolled were randomized 1:1 to receive either HLX04-O (1.25 mg) or ranibizumab (0.5 mg) IVT, administered every 4 weeks. The treatment continued for 1 year until death, withdrawal of consent, loss to follow-up, or study termination by the Sponsor. The primary endpoint of this study was mean change from baseline in best corrected visual acuity (“BCVA”) at Week 36. The key secondary endpoint was mean change from baseline in BCVA at Week 48; secondary endpoints included other efficacy, safety, tolerability, and pharmacokinetics. The results showed that the primary and key secondary endpoints of this study were met, with the mean change in BCVA from baseline at Week 36 and Week 48 in the HLX04-O group being non-inferior to that in the ranibizumab group. Additionally, HLX04-O had a good safety profile, with similar overall, ocular and non-ocular safety results compared to ranibizumab in wAMD patients.
Moving forward, Henlius will actively advance the development of innovative biologics and continue to deliver affordable, effective treatment options to patients worldwide with high efficiency.
About wAMD
Age-related macular degeneration is one of the leading causes of visual impairment and blindness in the elderly worldwide.1 According to the World Health Organization (WHO), about 30 million people have suffered from AMD globally, and about half a million people become blind due to AMD each year.2 Wet age-related macular degeneration (wAMD) is characterized by the formation of subretinal choroidal neovascularization (CNV) and is responsible for approximately 90% of cases of AMD-related blindness. Due to an aging population, wAMD has become a serious social medical problem and indicated a huge burden of unmet need.3 With the development of treatment for fundus diseases, anti-VEGF drugs are becoming the first-line therapy for the management of wAMD,4 and the efficacy and safety of vitreous injection of bevacizumab for wAMD have been verified in multiple clinical studies.5-11
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