HENLIUS(02696.HK): HLX04-O Meets Primary Endpoint in Global Multicenter Phase 3 Trial for Wet Age-Related Macular Degeneration

NewTimeSpace · 2026/06/16 17:12 · By Xuran Lin

NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. (02696.HK) announced that the global multicenter Phase 3 clinical study of HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody injection for the treatment of wet age-related macular degeneration (wAMD), has reached its primary endpoint. The trial results demonstrated that the mean change in best corrected visual acuity (BCVA) from baseline at Week 36 and Week 48 in the HLX04-O group was non-inferior to that of the ranibizumab group, with a favorable safety profile.

NewTimeSpace News: On 16 June 2026, Shanghai Henlius Biotech Co., Ltd. (02696.HK) released a voluntary announcement stating that the global multicenter, Phase 3 non-inferiority clinical trial evaluating HLX04-O (recombinant anti-VEGF humanized monoclonal antibody injection) for wet age-related macular degeneration (wAMD) successfully achieved the primary study endpoint. Trial data showed that the average BCVA improvement from baseline at Week 36 and Week 48 in the HLX04-O cohort met both primary and key secondary endpoints with non-inferiority versus ranibizumab, alongside well-tolerated safety performance.

This study is a global multicenter, randomized, double-blind, positive-controlled Phase 3 non-inferiority trial. Enrolled patients were randomly assigned at a 1:1 ratio to receive intravitreal injection of either HLX04-O (1.25 mg) or ranibizumab (0.5 mg) once every four weeks for a one-year treatment period.

HLX04-O is a novel ophthalmic formulation optimized based on the Company’s self-developed Hanbeitai^® (bevacizumab injection) to meet ocular clinical demands. Previously, the Phase 3 clinical trial of HLX04-O in Chinese patients hit its primary endpoint in April 2025, and its New Drug Application (NDA) was accepted by the National Medical Products Administration (NMPA) in August 2025. According to IQVIA statistics, global sales of drugs indicated for wAMD reached approximately USD 13.315 billion in 2025.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.

Tags：

HENLIUS 02696.HK Clinical Trial