HONG KONG, 26 September 2024 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacture and commercialization of therapies that address significant unmet medical needs, is pleased to announce that it completed the Last Patient Last Visit in 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 20 September 2024.

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 57 centres and enrolled a total of 488 patients. It was led by Professor Chen Youxin from Peking Union Medical College Hospital as the Principal Investigator.

TAB014 is the first clinical-stage bevacizumab-based antibody indicated for wAMD in China. Bevacizumab is a clinically-validated, anti-vascular endothelial growth factor (anti-VEGF) drug. Globally, bevacizumab is approved for oncology treatment through intravenous infusion. However, there has been increasing off-label usage of bevacizumab via intravitreal injection for the treatment of wAMD.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are thrilled to have reached this critical milestone in the development of TAB014, which is our first innovative back-of-the-eye drug in the Phase III trial stage.  I am also proud that the trial was completed with high quality, achieving a dropout rate of only 8.8%. Our commitment to improving the eye health of patients across Asia remains unwavering, and we are determined to bring TAB014 to market as swiftly as possible.”

ABOUT TAB014

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.

ABOUT 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 US$241.5 million to approximately US$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.

ABOUT THE AGREEMENT WITH TOT BIOPHARM Co., Ltd.

In March 2022, the Company announced that Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited (“Zhaoke Guangzhou”), a wholly-owned subsidiary of the Company and TOT BIOPHARM Co., Ltd. (“TOT Suzhou”, a wholly-owned subsidiary of TOT BIOPHARM International Company Limited (“TOT BIOPHARM”), SEHK: 1875), entered into a supplemental agreement (the “Current Supplemental Agreement”), pursuant to which Zhaoke Guangzhou will have full control in the execution of clinical trials and the ultimate decision-making power in the development and commercialization of TAB014 in China, Hong Kong and Macau. Zhaoke Guangzhou is also given the right of developing TAB014 for other ophthalmic indications besides wAMD or novel formulations for ophthalmic indications. TOT Suzhou will continue to be responsible for the manufacturing of TAB014 for clinical trial and commercial purposes.

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