The CDE's official website recently announced that the marketing application for melatonin granules from Suzhou Yifan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yifan Pharmaceutical, has been accepted. This Class 4 generic chemical drug, with 1g and 2mg dosages, targets sleep difficulties in Chinese children aged 6-15 with neurodevelopmental disorders.

Melatonin, an endogenous hormone that regulates sleep-wake cycles, has clear clinical value in the treatment of childhood neurodevelopmental disorders. However, as of August 2025, only imported, originator-developed melatonin granules had been approved for marketing in China. Yifan Pharmaceuticals has applied for marketing authorization under the Class 4 chemical drug registration classification, becoming the first company in China to do so.
There are a large number of children with neurodevelopmental disorders, including those with autism spectrum disorders and attention deficit hyperactivity disorder. Among these children, up to 50%-80% have sleep problems, of which difficulty falling asleep is the most common. Unlike adult preparations, children's medications require more precise dosage control and more stringent safety evaluations, and the research and development threshold is higher. There

has always been a huge gap in the market for drugs for children with neurodevelopmental disorders. Due to the difficulty of research and development and the complexity of clinical trials, many pharmaceutical companies are deterred from developing children's-specific drugs. Yifan chose this track, recognizing clinical needs while avoiding overcrowded competition for common disease drugs.

At present, Yifan Pharmaceutical has invested approximately 13.69 million yuan in the research and development of melatonin granule raw materials and preparations. In the field of pharmaceutical research and development, this investment scale is relatively moderate, reflecting the cost advantage of generic drug research and development.

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