SHANDONG XINHUA (00719) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd. ("Xinda Pharmaceutical"), has recently received the Drug Registration Certificate for Ursodeoxycholic Acid Capsules issued by the National Medical Products Administration.

In January 2024, Xinda Pharmaceutical submitted the marketing authorization application materials for Ursodeoxycholic Acid Capsules to the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which was accepted for review. The Drug Registration Certificate was obtained in September 2025, with the evaluation conclusion being: approved for registration.

The product is indicated for the treatment of cholesterol gallstones in the gallbladder (must be X-ray translucent stones with normal gallbladder contractile function); cholestatic liver diseases (such as primary biliary cirrhosis); and bile reflux gastritis. The product is classified as a Class A variety in the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2024).

According to relevant statistical data, the sales volume of ursodeoxycholic acid in China's public medical institutions reached approximately RMB 2.155 billion in 2024.

The announcement stated that the approval of Xinda Pharmaceutical's Ursodeoxycholic Acid Capsules application in September 2025 will help enrich the company's digestive system drug portfolio and enhance the company's overall competitiveness.