By Fineline Cube 
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced positive results from the Phase III clinical study for its anti-VEGF monoclonal antibody (mAb) HLX04-O in patients with wet age-related macular degeneration (wAMD). The study demonstrated that HLX04-O met its primary endpoint, showing non-inferiority to ranibizumab in improving best corrected visual acuity (BCVA) at week 48.
Clinical Trial Results
The average number of letters improved from baseline in the BCVA of the HLX04-O group was comparable to the ranibizumab group. Additionally, HLX04-O exhibited a safety profile on par with ranibizumab, across overall, ocular, and non-ocular populations of wAMD patients.
Product Background
HLX04-O is a novel ophthalmology product developed based on HanBeiTai, a biosimilar of Roche’s Avastin (bevacizumab). It is being advanced for the treatment of wAMD, leveraging the established efficacy and safety profile of its reference product.-Fineline Info & Tech