Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company, is pleased to announce that the National Medical Products Administration (“NMPA”) of China has recently accepted the New Drug Application (“NDA”) for one of the Company’s core products, NVK002 (Atropine Sulphate Eye Drops 0.02%) for the treatment of myopia progression in children. The NDA is being reviewed as a Class II innovative drug.

In addition, on 2 January 2025, the NMPA officially accepted the simplified new drug application for the Company's drug NVK002 (Atropine Sulphate Eye Drops 0.01%), which is also currently under review.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, commented, “We are  proud to become the first company in China to receive an NDA acceptance for atropine sulphate eye drops 0.02%. With these drops, and with our atropine sulphate eye drops 0.01% also currently under NMPA review, we aim to provide safe and effective treatments for hundreds of millions of myopic children and adolescents. We will continue to work closely with the NMPA throughout the review process of NVK002, striving to benefit myopia patients as soon 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.

About Myopia Progression Control

Myopia has become a major social issue that affects 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.