Shanghai, China, April 2, 2025 - Henlius (2696.HK) announced that the phase 3 clinical trial for the HLX04-O, a recombinant anti-VEGF humanised monoclonal antibody injection jointly developed by the company and Essex, for the treatment of Chinese patients with wet age-related macular degeneration (wAMD), met the primary endpoint. The company plans to partner with Essex to submit a New Drug Application (NDA) in China, with HLX04-O expected to become the country's first bevacizumab approved for the treatment of ophthalmic diseases.
NCT05003245 is a multi-center, 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) IVT 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 of letters in best corrected visual acuity (“BCVA”) from baseline at week 48; secondary endpoints included other efficacy, safety, tolerability, and pharmacokinetics. The results showed that the primary endpoint of this study was met, with the mean change in BCVA from baseline at 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.
HLX04-O is a recombinant anti-VEGF humanized monoclonal antibody injection constructed using genetic engineering technology independently 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 signalling 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.
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 European Union, and the United States. 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].
References
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