HONG KONG, 2 January 2025 – 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 the National Medical Products Administration (“NMPA”) of China has officially accepted the Abbreviated New Drug Application (“ANDA”) for the drug NVK002 (low-dose atropine 0.01%).

NVK002 is one of the Company’s highest potential coreproducts. It is a treatment for myopia progression in children.The ANDA is based on the results from its Phase III clinical trial in China. In August 2023, the Company completed the last patient last visit of its one-year Phase III clinical trial (“Mini-CHAMP”) in China. The trial involved 16 centers and enrolled 526 patients. Mini-CHAMP successfully met its primary efficacy endpoint, achieving statistically and clinicallymeaningful differences versus placebo, and demonstrated strong safety and efficacy and high patient tolerance.

The Company has conducted a parallel two-year Phase III clinical trial (“China CHAMP”) and completed the last patient last visit in August 2024. The trial involves 18 centers andenrolled 777 patients. The top-line results of China CHAMP showed significant safety and efficacy of NVK002, adding evidence to the drug as a potential treatment for the progressionof myopia in children.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are pleased to announce the official acceptance of the ANDA for NVK002 by the NMPA, marking a significant milestone for Zhaoke and rounding off on a high note, a highly productive year in 2024. This acceptance reinforces Zhaoke's position as the second market entrant in a competitive yet opportunity-rich landscape in China. We are committed to collaborating closely with the relevant regulatory authorities to accelerate the launch of NVK002, aiming to provide a high-quality treatment for over 163 million children and adolescents affected by myopia.”

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.

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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