On June 16, Henlius announced that HLX04-O, its recombinant anti-VEGF humanized monoclonal antibody injection, has met the primary endpoint in an international multicenter Phase III clinical study in patients with wet age-related macular degeneration (wAMD).<\/p>\n\n\n\n
This study was an international multicenter, randomized, double-blind, active-controlled non-inferiority Phase III clinical trial designed to compare the efficacy and safety of HLX04-O versus ranibizumab via intravitreal (IVT) injection in patients with wAMD. Enrolled patients were randomized 1:1 to receive HLX04-O (1.25 mg) or ranibizumab (0.5 mg) via IVT injection every 4 weeks, with treatment continuing for one year unless the patient experienced death, withdrew consent, was lost to follow-up, or the study was terminated by the sponsor.<\/p>\n\n\n\n
The primary endpoint of this study was the mean change from baseline in best corrected visual acuity (BCVA) at Week 36, and the key secondary endpoint was the mean change from baseline in BCVA at Week 48. Secondary endpoints included other efficacy, safety, tolerability, and pharmacokinetic measures. The study results showed that the mean changes from baseline in BCVA at Week 36 and Week 48 in the HLX04-O group were both non-inferior to those in the ranibizumab group, meeting the primary and key secondary endpoints. In addition, the overall, ocular, and non-ocular safety profiles of HLX04-O were similar to those of ranibizumab in the wAMD patient population, with a favorable safety profile.<\/p>\n\n\n\n
HLX04-O is a new ophthalmic formulation developed based on Henlius’ independently developed Hanbaitai\u00ae (bevacizumab injection). The formulation, specification, and manufacturing process were optimized to meet ophthalmic requirements while keeping the active ingredient unchanged, for the treatment of wAMD.<\/p>\n\n\n\n
In July 2023, HLX04-O demonstrated favorable safety, tolerability, and preliminary efficacy in a Phase I\/II clinical study in patients with wAMD. In April 2025, HLX04-O met the primary endpoint in a Phase III clinical study conducted in Chinese patients with wAMD. In August 2025, the New Drug Application (NDA) for HLX04-O for the treatment of wAMD was accepted by the NMPA Center for Drug Evaluation.<\/p>\n\n\n\n
Of note, Henlius has previously granted Essex exclusive global rights for ophthalmic therapeutic use and\/or therapies related to Hanbaitai\u00ae, with an agreement to co-develop related products with Essex. Henlius and Essex will bear 20% and 80% of the costs and expenses related to product development activities, respectively.<\/p>\n\n\n\n
Buy HLX04-O <\/strong>from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.<\/p>\n","protected":false},"excerpt":{"rendered":" On June 16, Henlius announced that HLX04-O, its recombinant anti-VEGF humanized monoclonal antibody injection, has met the primary endpoint in an international multicenter Phase III clinical study in patients with wet age-related macular degeneration (wAMD). This study was an international multicenter, randomized, double-blind, active-controlled non-inferiority Phase III clinical trial designed to compare the efficacy and […]<\/p>\n","protected":false},"author":3,"featured_media":3376,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-4362","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"blocksy_meta":[],"yoast_head":"\n