SHANDONG XINHUA (00719) Secures Drug Registration Certificate for Phloroglucinol Injection

Stock News2025-12-29

SHANDONG XINHUA (00719) announced that the company has recently received the Drug Registration Certificate for phloroglucinol injection (hereinafter referred to as "the product") issued by the National Medical Products Administration. Looking back, in July 2024, Xinhua Pharmaceutical submitted the domestic production marketing authorization registration application materials for the product to the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which was accepted. After more than a year, by December 2025, the application was finally approved for registration, and the company successfully obtained the relevant certificate. It is reported that the product is mainly used to relieve acute spasmodic pain caused by digestive system and biliary dysfunction, and also has therapeutic effects on acute spasmodic urethral, bladder, renal colic, and gynecological spasmodic pain. Notably, the drug has been included in the Class B category of the National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2025 Edition). In addition, according to industry statistics, the sales of phloroglucinol injection in China's public medical institutions market in 2024 reached approximately RMB 900 million.

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