SHANDONG XINHUA (00719) subsidiary obtains drug registration certificate for Donepezil Hydrochloride Orally Disintegrating Tablets.

SHANDONG XINHUA (00719) announced that recently, Shandong Zibo Xinda Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinda Pharmaceutical"), a wholly-owned subsidiary of SHANDONG XINHUA Co., Ltd., received the Drug Registration Certificate for Donepezil Hydrochloride Orally Disintegrating Tablets (hereinafter referred to as "this product") approved and issued by the National Medical Products Administration. In February 2025, Xinda Pharmaceutical submitted the marketing authorization application materials for Donepezil Hydrochloride Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) of the National Medical Products Administration and the application was accepted. In September 2026, the Drug Registration Certificate was obtained, with the review conclusion being: approval of registration. This product is used for the treatment of symptoms of mild, moderate, or severe Alzheimer's disease. This product belongs to Category B in the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog (2025). According to relevant statistics, the sales of donepezil formulations in Chinese public medical institutions in 2025 were approximately RMB 620 million.