By Fineline Cube Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary, Shanghai Henlius Biotech, Inc. (HKG: 2696), has announced the completion of a Phase I/II study for its anti-VEGF monoclonal antibody (mAb) HLX04-O in the treatment of wet age-related macular degeneration (wAMD). The drug has reportedly demonstrated a good safety and tolerability profile during the study.
Study Design and Patient Enrollment
The single-arm, open-label, multi-center Phase I/II study was designed to assess the safety and preliminary efficacy of HLX04-O via intravitreous injection (IVT) in active wAMD patients. The study enrolled six patients in the safe induction period and a total of 20 patients, including the six from the safe induction period, in the Phase II study. The research results indicate that HLX04-O IVT is safe and well tolerated in wAMD patients, showing preliminary signs of efficacy.
HLX04-O: A New Ophthalmology Product Based on Avastin
HLX04-O is a new ophthalmology product developed as a biosimilar version of Swiss giant Roche’s Avastin (bevacizumab). It is currently under development to treat wAMD and is undergoing Phase III clinical studies globally. The successful completion of the Phase I/II study and the positive preliminary results mark a significant step forward in the development of this potential treatment for wet AMD.-Fineline Info & Tech