Xin Lang Cai Jing·2025-09-16 09:09Core Viewpoint - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received the drug registration certificate for Ursodeoxycholic Acid Capsules from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Company Summary - Xinda Pharmaceutical, a wholly-owned subsidiary of Xinhua Pharmaceutical, has been approved for Ursodeoxycholic Acid Capsules, which are used to treat cholesterol gallstones, cholestatic liver disease, and bile reflux gastritis [1] - The drug is classified as a Class A item in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024, enhancing its market accessibility [1] Industry Summary - The estimated sales revenue for Ursodeoxycholic Acid in Chinese public medical institutions is approximately 2.155 billion yuan in 2024, indicating a substantial market opportunity for the newly approved drug [1] - Xinda Pharmaceutical submitted the application for marketing authorization in January 2024 and received approval in September 2025, reflecting the regulatory timeline for new drug approvals in the industry [1]