HONG KONG, 12 June 2025 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company, is delighted to announce that the National Medical Products Administration (“NMPA”) of China has recently accepted the Biologics License Application (“BLA”) for one of the Company’s core products, TAB014, for the treatment of wet age-related macular degeneration (“wAMD”). It is the first bevacizumab-based antibody filing BLA indicated for wAMD in China.

The BLA is based on the successful results of the Company’s Phase III clinical trial in China. It 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 57 centres and enrolled a total of 488 patients, led by Professor Chen Youxin from Peking Union Medical College Hospital as the Principal Investigator.

In January 2025, Zhaoke also announced the positive top-line results from the Phase III clinical trial of TAB014. The clinical trial successfully met its primary endpoints and key secondary endpoints.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, commented, “The NMPA acceptance of TAB014’s BLA is a significant milestone achievement for Zhaoke. This marks a new chapter for the Company, as it is our first innovative asset, which targets back-of-the-eye diseases, entering the regulatory stage. Together with NVK002 and CsA Ophthalmic Gel, the R&D progress we have made in these three flagship drug assets, reflects our consistent development in ophthalmology innovation. We are very excited about the near future, where more regulatory approvals are expected, not only to drive revenue for the company, but more importantly, to deliver high-quality treatment options to patients in need.”

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.

- End -