Recently, Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, submitted a marketing authorization application for HR19034 Eye Drops (Atropine Sulfate Eye Drops) to the National Medical Products Administration, which has been accepted. This product is mainly used to prevent and control the progression of myopia in children and adolescents.

According to the Yaozhi Data global drug analysis system, Hengrui Medicine's HR19034 project started clinical trials in April 2021. After completing the Phase I trial, the company immediately started Phase II/Phase III research. According to Hengrui's announcement, the project will complete a three-year clinical trial in August 2024. Research data showed that HR19034 was superior to the control group in terms of the primary endpoint and demonstrated good safety and tolerability in children with myopia.
The most common application of atropine in ophthalmology is mydriasis. Atropine sulfate at a concentration of 1% is usually used for fundus examination and eye examination and glasses fitting. Studies in recent years have shown that low-concentration atropine sulfate can effectively inhibit the progression of myopia by acting on the ciliary muscle and other mechanisms. This discovery opens up new clinical application areas for the drug.

In terms of medication for the prevention and control of myopia in children in China, in March 2024, Shenyang Xingqi Eye Drops' 0.01% atropine sulfate eye drops were approved for marketing, becoming the first product of its kind in China to obtain the "National Medicine Approval Number". The approval of this product fills the gap in medication for the prevention and control of myopia among children in China. At present, atropine sulfate eye drops products of many domestic pharmaceutical companies have entered the phase III clinical stage. With the acceptance of Hengrui Medicine's HR19034 application, the market competition landscape in this field will change. Judging from the current progress, more similar products may be approved for marketing in China in the next few years, providing more treatment options for the prevention and control of myopia in children.

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