Core Viewpoint - The company Zhaoke Ophthalmology-B (06622) has had its application for the registration of atropine sulfate eye drops accepted by the Australian Therapeutic Goods Administration, aimed at treating myopia progression in children [1] Group 1: Application Details - The application for the 0.01% atropine sulfate eye drops (product code: NVK002) was officially acknowledged by the Therapeutic Goods Administration on January 5, 2026, and has passed the preliminary review stage [1] - The application is supported by results from the company's Phase III clinical trials [1] Group 2: Product Information - Atropine sulfate eye drops (NVK002) are an experimental new topical ophthalmic solution designed to control myopia progression in children and adolescents [1] - The product features a patented formulation that successfully addresses the instability of low-concentration atropine, with global intellectual property protection [1] - The eye drops are preservative-free and are expected to have a shelf life of over 24 months [1] Group 3: Market Position - According to Zhi Shi Consulting, NVK002 is currently one of the most advanced atropine candidates globally for treating myopia progression, targeting a broad patient demographic of children and adolescents aged 3 to 17 [1]

Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622.HK), has had its registration application for atropine sulfate eye drops (0.01% dosage, product code: NVK002) for treating myopia progression in children accepted by the Australian Therapeutic Goods Administration (TGA) [1] Group 1 - The TGA has officially notified the company that its application has passed the preliminary review and will undergo further evaluation [1] - The application is supported by results from the company's Phase III clinical trials [1] - NVK002 is a novel experimental topical eye solution designed to control myopia progression in children and adolescents [1] Group 2 - NVK002 features a patented formulation that successfully addresses the instability of low-concentration atropine, with intellectual property protection globally [1] - The eye drops are preservative-free and are expected to have a shelf life of over 24 months [1] - According to data from Zhi Shi Consulting, NVK002 is one of the most advanced atropine candidates globally for treating myopia progression, targeting a broad patient group aged 3 to 17 years [1]

Core Viewpoint - The announcement highlights the approval of a new low-concentration atropine eye drop by the National Medical Products Administration, which is expected to uniquely position the company in the market for myopia treatment in children aged 6-12 [1] Group 1: Product Approval - The company received approval for supplementary applications of atropine sulfate eye drops in two new concentrations: 0.02% and 0.04% [1] - The approval numbers are H20258301 and H20258302, with a validity period until March 2029 [1] Group 2: Market Position - This product is the first of its kind in China aimed at delaying the progression of myopia in children with a spherical equivalent of -1.00D to -4.00D [1] - Phase III clinical trials demonstrated that both concentrations significantly delayed myopia progression compared to a placebo, with good safety profiles [1] - Currently, there are no competing products with the same concentrations available in the domestic or international markets, indicating a potential monopoly in this niche [1]

Core Viewpoint - The National Medical Products Administration of China has accepted the new drug application for NVK002 (Atropine Sulfate Eye Drops 0.02%), which is designed to be administered once daily to control the progression of myopia in children [1] Group 1: Market Potential - There are approximately 700 million myopia patients in China, with 163 million being children and adolescents, indicating a significant market demand for NVK002 [1]