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 positive topline results from its two-year Phase III clinical trial (“China CHAMP”) of NVK002, one of the Company’s core products.

Analysis of the study, after two years of treatment, demonstrated statistically significant differences in the primary efficacy endpoints between the NVK002 groups (both 0.01% and 0.02% doses) and the placebo group. The NVK002 groups performed better than the placebo group, and indicated a dose-dependent effect. NVK002 at both doses demonstrated strong safety and high patient compliance.

China CHAMP is a randomized, double-blind, placebo-controlled and multicenter Phase III clinical study. Its main objective is to evaluate the efficacy and safety of NVK002 (low dose atropine 0.01% and 0.02%) in the treatment of myopia progression in children and adolescents in the Chinese population. This trial involved 18 centers and enrolled 777 patients.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are excited by the strong efficacy and safety data from the China CHAMP trial. Zhaoke Ophthalmology continues to be well-positioned to become the second company to receive approval for myopia eye drops in China. We hope to commercialize the drug and bring it to patients as quickly as possible.”

ABOUT NVK002

NVK002 is an investigational novel topical ophthalmic solution to control myopia progression in children and adolescents. NVK002 has a proprietary formulation that successfully addresses the instability of low-concentration atropine; this technology has intellectual property protection globally. It is preservative-free with an expected shelf life of over 24 months. According to information from China Insights Consultancy (“CIC”), NVK002 is currently one of the most advanced atropine drug candidates globally for treating myopia progression, and targets the broadest patient group, covering children and adolescents from 3 to 17 years old.

The clinical development of NVK002 involves two different concentrations of atropine to allow flexibility in achieving maximal efficacy and minimal adverse effects for tailoring to the needs of individual patients.

ABOUT MYOPIA PROGRESSION CONTROL

Myopia has become a major social issue that plagues the growth of children and adolescents in China. In the “14th Five-Year National Health Plan” issued by the State Council of the Chinese government, clear instructions have been made for the prevention and treatment of myopia in children and adolescents, and reduction of the overall myopia rate among children and adolescents nationwide by more than 0.5% per year. The Ministry of Education also issued the “Proposal for Parents of Comprehensive Prevention and Control of Myopia in Children and Adolescents”, calling on parents to pay attention to their children’s eye health.

According to the World Health Organization and CIC, currently there are approximately 700 million myopia patients in China; among them, 163 million are children and adolescents, who may be able to benefit from NVK002. The Board believes the potential commercialization of NVK002 will allow the Company to establish a leading position in meeting these huge unmet needs in China.

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