恒瑞医药硫酸阿托品滴眼液 上市申请获受理

Group 1 - Company Heng Rui Medicine announced that its subsidiary Chengdu Shengdi Pharmaceutical received a notice from the National Medical Products Administration regarding the acceptance of the drug listing application for HR19034 eye drops [1] - The clinical trial for atropine eye drops (HR19034-301) reached its primary endpoint in August 2024, demonstrating significant efficacy and safety in treating myopia in children [1][2] - The study involved 509 children with myopia and was conducted as a randomized, double-blind, placebo-controlled trial, indicating the drug's potential in addressing the rising prevalence of myopia among children [1][2] Group 2 - The global prevalence of myopia is rapidly increasing, with projections indicating that by 2050, there will be 4.758 billion myopic individuals, accounting for 49.8% of the total population [2] - In China, the myopia prevalence among children and adolescents was reported at 52.7% in 2020, with significant rates among different educational levels: 35.6% in primary school, 71.1% in middle school, and 80.5% in high school [2] - Current methods for correcting myopia in children include glasses, contact lenses, orthokeratology lenses, and low-concentration atropine eye drops, with the latter gaining attention for its effectiveness in slowing myopia progression [2] Group 3 - HR19034 eye drops utilize B/F/S three-in-one filling technology and contain atropine sulfate as the active ingredient, which acts as a competitive antagonist to muscarinic acetylcholine receptors, potentially alleviating myopia progression [3] - The product does not require preservatives, which may enhance its safety profile [3] - Similar products have been approved in markets including Australia, India, Japan, and China, with a total of approximately 50.32 million yuan invested in the research and development of HR19034 eye drops [3]