Zhaoke Ophthalmology Limited announce that the patient enrollment was completed for the Phase III clinical trial of one of the Company's core drug candidates, TAB014, for the treatment of wet (neovascular) age-related macular degeneration ("wAMD"), on September 16, 2023, ahead of schedule. The patient enrollment was also completed for the Phase III clinical trial of Epinastine HCl targeting allergic conjunctivitis with a dual mechanism of action of anti-histamine and mast cell stabilization, on September 15, 2023. The last patient last visit was completed on September 28, 2023.

The Phase III clinical trial of TAB014 is a randomized, double-blind and non-inferiority study. The main objective of the study is to evaluate the change from baseline in best corrected visual acuity (BCVA) at week 52 in the TAB014-treated subjects group compared with Lucentis®-treated subjects group. The study involved approximately 60 centres and enrolled a total of 488 patients, led by Professor Chen Youxin from Peking Union Medical College Hospital as the Principal Investigator.

The Phase III clinical trial of Epinastine HCl is a multicenter, randomized, double-blind, positive-controlled Phase III clinical study on the efficacy and safety of 0.05% epinastine hydrochloride eye drops in the treatment of patients with seasonal allergic conjunctivitis. The study involved approximately 14 centres and enrolled a total of 266 patients. As disclosed in previous announcements, the Company's New Drug Application ("NDA") of CsA Ophthalmic Gel for the treatment of dry eye disease ("DED") has been accepted by the Center For Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") on June 8, 2022.

It passed the on-site regulatory and clinical trial inspections by the NMPA, and the Good Manufacturing Practice ("GMP") conducted by the Guangdong Medical Products Administration in January 2023. As an update to this application, following several rounds of communication between the Company and regulatory authorities, the Company expects it will require more time than is remaining in the statutory supplementary material process to adequately address the additional questions from the CDE. As such, after prudent considerations and consultations with the CDE, the Company has decided to voluntarily withdraw the application and will resubmit the NDA once the supplementary documentation is complete.

The Company will closely monitor and actively advance the subsequent progress of the NDA, and will make further announcement(s) as and when appropriate. TAB014 (recombinant humanized anti-vascular endothelial growth factor ("VEGF") monoclonal antibody) is an ophthalmic formulation of bevacizumab being developed for the treatment of wAMD. The main pathological feature of wAMD is choroidal angiogenesis in the macula, with VEGF playing an important role in the angiogenesis process.

TAB014 is able to bind specifically to VEGF and block it from binding to its receptors, thereby inhibiting angiogenesis. TAB014 will eventually be administered as an intravitreal injection for the treatment of wAMD. wAMD is a leading cause of vision loss and blindness in people over 50 years old in China and globally.

According to China Insights Consultancy the market size of wAMD drugs in China is forecast to increase from $241.5 million to approximately USD 3.5 billion from 2019 to 2030, at a CAGR of 27.5%. TAB014 is the first bevacizumab-based antibody under clinical development indicated for wAMD in China, and is expected to be a cost-effective therapy. The clinical research and commercialization project in relation to TAB014 was listed by the Development Center for Medical Science & Technology of the National Health Commission of China as a special major project for technologies of innovative manufacturing of major new drugs at the end of 2019.