HONG KONG, 13 January 2026 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company, is pleased to announce that on 5 January 2026, the Company’s registration application for its Atropine Sulfate Eye Drops (0.01% dose, product code: NVK002), for the treatment of myopia progression in children, has been accepted for evaluation by the Therapeutic Goods Administration of Australia (the “TGA”).
The TGA has formally acknowledged that Zhaoke’s application has passed preliminary assessment and will proceed to the TGA’s evaluation process applicable to all prescription medicines seeking to be registered in Australia. The application to the TGA has been based on positive data from the Phase III clinical trial conducted by the Company.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, commented, “We are thrilled to be making that our Atropine Sulfate Eye Drops have entered the registration evaluation process in Australia. This marks our second major milestone in Australia, following our partnership with AFT Pharmaceuticals for our presbyopia drug BRIMOCHOL™ PF. It also demonstrates our global capabilities and the effective execution of our Asia-Pacific strategy. Australia is our fourth international market for Atropine Sulfate Eye Drops, following South Korea, Thailand, and Indonesia. This diversity of markets underscores our commitment to global expansion, and our focus on Asia-Pacific. Our goal is to make this high-quality myopia treatment accessible to patients worldwide.”
About Atropine Sulfate Eye Drops (NVK002)
Atropine Sulfate Eye Drops (NVK002) is an investigational novel topical ophthalmic solution to control myopia progression in children and adolescents. It 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.
- End -