Shanghai, China, August 13, 2025 – Henlius (2696.HK) announced that the New Drug Application (NDA) for the HLX04-O, a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the company and Essex, for the treatment of wet (neovascular) age-related macular degeneration(wAMD) has been accepted by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). As of now, none of the bevacizumab products marketed in Chinese mainland has been approved for the treatment of wAMD.
Age-related macular degeneration is one of the leading causes of visual impairment and blindness in the elderly worldwide. It is estimated that the number of cases worldwide will reach 288 million by 2040[1]. Wet age-related macular degeneration (wAMD) is characterized by the formation of subretinal choroidal neovascularization (CNV), associated with most of the vision loss related to AMD[2]. Due to an aging population, wAMD has become a serious social medical problem and indicated a huge burden of unmet need[1]. With the development of treatment for fundus diseases, anti-VEGF drugs are becoming the first-line therapy for the management of wAMD[2], and the efficacy and safety of vitreous injection of bevacizumab for wAMD have been verified in multiple clinical studies[3-9].
HLX04-O is a recombinant anti-VEGF humanized monoclonal antibody injection constructed using genetic engineering technology developed by Henlius. HLX04-O can inhibit VEGF’s binding to its receptor Flt-1 (VEGFR-1) and KDR (VEGFR-2) on endothelial cells to inhibit the activation of its tyrosine kinase signaling pathway, inhibit endothelial cell proliferation and reduce angiogenesis, thereby treating eye diseases associated with angiogenesis. 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. 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.
The submission of NDA for HLX04-O is primarily supported by a multi-centre, randomised, double-blind, active-controlled, non-inferiority phase 3 clinical study(NCT05003245) comparing intravitreal injections (IVT) of HLX04-O versus ranibizumab in patients with wAMD. The study met its primary endpoint in April 2025, demonstrating non-inferiority of HLX04-O to ranibizumab in the mean change from baseline in best-corrected visual acuity (BCVA) at week 48. HLX04-O exhibited a favorable safety profile, with no new safety signals identified. In addition to NCT05003245, Henlius has conducted an international multicenter phase 3 clinical trial (NCT04740671) for HLX04-O, enrolling subjects in regions including China, Australia, the Europe, and the United States.
In the future, Henlius will continue to collaborate with partners to promote the development and commercialization of innovative biopharmaceutical products, ensuring that affordable and effective treatment regimens benefit more patients worldwide.
Reference
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