On March 11th, Xingqi Eye Medicine's independently developed 0.01% atropine sulfate eye drops officially obtained market approval from the National Medical Products Administration. It is worth noting that there are currently no similar products with myopia related indications approved in China. It is understood that Xingqi Eye Medicine has received the Drug Registration Certificate for Atropine Sulfate Eye Drops approved and issued by the National Medical Products Administration. This product is an ophthalmic preparation with atropine sulfate as the active ingredient. The approved clinical indications are: this product is used to delay the progression of myopia in children aged 6 to 12 years old with spherical lens powers ranging from -1.00D to -4.00D (astigmatism ≤ 1.50D, anisometropia ≤ 1.50D). Myopia is a major global public health issue, and China is the world's largest country with myopia. According to a survey by the National Health Commission, as of 2020, the overall myopia rate among children and adolescents in China was 52.7%, including 14.3% for 6-year-old children, 35.6% for elementary school students, 71.1% for middle school students, and 80.5% for high school students. It is particularly noteworthy that the age of onset of myopia in minors has shown a significant trend of advancing, and it is urgent to prevent and control myopia in children and adolescents. Yang Qiang, deputy general manager and R&D director of Xingqi Ophthalmology, said that 0.01% atropine sulfate eye drops have been used in Asia, Singapore, Japan, India, Hong Kong, China, Taiwan, China and other regions to prevent and control myopia for nearly 20 years. After many years of clinical use in the real world by tens of thousands of myopic children, it has good safety and effectiveness. It can delay the progress of myopia by 60% when used alone, and has the smallest rebound effect after drug withdrawal. The drug is aimed at the huge market for adolescent myopia control. Before its official approval, Xingqi Ophthalmology had obtained huge profits in the form of "hospital preparations+Internet sales". In May 2022, the National Medical Products Administration publicly solicited opinions on the Implementation Regulations of the Drug Administration Law of the People's Republic of China (Revised Draft for Solicitation of Opinions). Among them, Article 82 of the Regulations on the Administration of Online Sales of Drugs states that the sale of drugs should be the variety held by the holder of the drug marketing license or the variety licensed for operation by the drug trading enterprise. According to the regulations, the low concentration atropine eye drops that have not yet been listed can no longer be sold in Internet hospitals. On July 22 of that year, the Internet Hospital applet of Shenyang Xingqi Eye Hospital issued an announcement on the suspension of atropine sales. Atropine has stopped its online after-sales service, and Xingqi Eye Pharmaceutical's performance has rapidly declined. Atropine eye drops are a type of M-cholinergic receptor inhibitor that can cause relaxation of the pupillary sphincter and ciliary muscles, resulting in dilation, elevated intraocular pressure, and modulation of paralysis. They are mainly used for dilated pupils and optometry. The clinical trial report on using atropine sulfate eye drops to delay the progression of myopia in children previously released by Xingqi Eye Medicine showed that there was a statistically significant difference in the main therapeutic indicators between the atropine sulfate eye drops group and the placebo group, which was superior to the placebo group, with good safety and patient compliance. (Lai Xin She)
Edit：GuoGuo Responsible editor：FangZhiYou
Source：gmw.cn
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