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山东华特达因健康股份有限公司 关于子公司签署褪黑素颗粒(曼乐静?)总经销合同的公告

Group 1 - The company, Shandong Huate Dain Health Co., Ltd., has signed an exclusive distribution agreement with Nobelpharma Co., Ltd. for melatonin granules (brand name: Manlejing) in mainland China [2][6] - The product is set to be approved for sale in China by July 2025 and is aimed at treating sleep difficulties in children aged 6-15 with neurodevelopmental disorders, addressing a significant clinical need in the market [3][9] - Nobelpharma, established in 2003 and based in Tokyo, Japan, focuses on the research and production of rare disease medications and has successfully launched three products in China [4] Group 2 - The agreement grants Dain Kangjian exclusive rights for the import, marketing, and sales of the product in mainland China, excluding Hong Kong, Macau, and Taiwan [6] - The initial term of the agreement is set for 10 years, with the possibility of renewal upon mutual agreement [7] - Dain Kangjian is responsible for market promotion and channel development, while Nobelpharma must ensure product quality meets Chinese regulatory standards and provide necessary technical support [8] Group 3 - The introduction of this product fills a market gap as it is the first melatonin formulation approved in China for treating sleep issues in children with neurodevelopmental disorders, showcasing significant clinical value and market potential [9] - This partnership enhances the company's pediatric product line, reinforcing its leading position in the children's health sector [10]