Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced the first patient enrollment in a Phase III clinical study for its core product TAB014, a recombinant anti-VEGF antibody, in neovascular wet age-related macular degeneration (wAMD). The randomized, double-blind, non-inferiority Phase III study is designed to assess the change from baseline in best-corrected visual acuity (BCVA) after 52 weeks of treatment. The comparator is Lucentis (ranibizumab). The study, led by Dr Chen Youxin from Peking Union Medical University Hospital, will involve 60 centers and 400 patients.
Study Details and Collaborations
TAB014 was the focus of a licensing deal between Tot Biopharmaceutical International Co., Ltd (HKG: 1875) and Lee’s Pharma in January 2017, granting the latter clinical and commercial development rights to the drug in China (including mainland China, Hong Kong, and Macau). Zhaoke and Tot Bio signed a supplementary agreement in March 2023, under which Zhaoke will have full control over the execution of clinical trials of TAB014 and final decision-making power over its development and commercialization in China, Hong Kong, and Macau. Zhaoke Guangzhou has also obtained the right to develop TAB014 for other ophthalmic indications in addition to wAMD, or to develop innovative prescriptions for ophthalmic indications. Tot Bio will continue to be responsible for the production of TAB014 for clinical trials and commercial use.-Fineline Info & Tech
