Shanghai, China, Jan, 29th, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the filing of clinical trial for HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody ophthalmic injection, for the treatment of wet age-related macular degeneration (wAMD) has been approved by the Therapeutic Goods Administration, Australia. The Phase 3 clinical study of the project in Australia is intended to be initiated in the near future.

Age-related macular degeneration is one of the leading causes of 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].

HLX04-O is a recombinant anti-VEGF humanized monoclonal antibody ophthalmic 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 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 HLX04, 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.

As of now, a series of studies including non-clinical pharmacodynamics, safety pharmacology, repeat-dose toxicity, pharmacokinetics, toxicokinetics, immunotoxicity, immunogenicity and local irritation of HLX04-O vitreous injection in the treatment of wAMD have been carried out, initially proving the efficacy and safety of HLX04-O. In the near future, a two-part, Phase 3, global, multicentre study of HLX04-O will be initiated in Australia to further evaluate the efficacy and safety in treatment of wAMD.