Zhongguancun subsidiary receives clinical trial approval for methylphenidate hydrochloride extended-release chewable tablets

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Beijing Huasu Pharmaceutical Co., Ltd., a subsidiary of Zhongguancun, has received a Drug Clinical Trial Approval Notice for methylphenidate hydrochloride extended-release chewable tablets, 40 milligram strength, issued by the National Medical Products Administration, approving clinical trials for attention deficit hyperactivity disorder, or ADHD. The drug is intended for treating ADHD patients aged six and older. Currently, only one original imported product is approved for marketing in China, and Beijing Huasu is the first domestic company to obtain clinical trial approval for a generic version of this drug. As of the announcement date, cumulative research and development investment in this project was approximately 5.88 million yuan. The company stated that this approval marks the product's entry into the clinical trial stage, but it still needs to complete clinical trials and pass review and approval before production and marketing. The development cycle is long, involves many steps, and carries uncertainty.

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First domestic generic approval for methylphenidate chewable tablets, entering clinical trials.

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