Shandong Xinhua's Subsidiary Secures Regulatory Approval for Donepezil Orally Disintegrating Tablets

Stock News

Sep 18

Shandong Xinhua Pharmaceutical Co., Ltd. (00719) has announced that its wholly-owned subsidiary, Zibo Xinda Pharmaceutical Co., Ltd., has received the Drug Registration Certificate from the National Medical Products Administration for Donepezil Hydrochloride Orally Disintegrating Tablets.

In February 2025, Xinda Pharmaceutical submitted the marketing authorization application for the product to the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which was accepted for review. In September 2026, the company obtained the Drug Registration Certificate, with the review conclusion approving the registration of the product.

The tablets are indicated for the treatment of mild, moderate, or severe symptoms of Alzheimer's disease. The product is classified as a Category B drug under the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalogue (2025 Edition).

According to relevant statistical data, sales of donepezil formulations in Chinese public medical institutions in 2025 reached approximately RMB 620 million.

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