On November 11th, GeLongHui reported that shandong xinhua pharmaceutical (00719.HK) recently announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd. (referred to as 'Xinda Pharmaceutical'), has received the Drug Registration Certificate for Febuxostat Tablets (referred to as 'the product') issued by the National Medical Products Administration, approving the application for its market launch.
In June 2023, Xinda Pharmaceutical submitted the application materials for the registration and marketing approval of Febuxostat Tablets to the Drug Evaluation Center (CDE) of the National Medical Products Administration and it was accepted. In November 2024, they obtained the Drug Registration Certificate, with the evaluation conclusion being: approved for registration, and the drug registration certificate was issued.
Febuxostat is a 2-arylthiazole derivative, a xanthine oxidase inhibitor that lowers serum uric acid concentrations by inhibiting uric acid synthesis. It is suitable for the long-term treatment of hyperuricemia with symptoms of gout and is taken orally. Febuxostat is highly selective, more effective than allopurinol, mainly metabolized by the liver, not dependent on renal excretion, safe and effective for patients with mild to moderate renal impairment, with minor side effects and proven efficacy.
Febuxostat tablets belong to the Category B varieties in the 'National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2023)'. According to relevant data, in 2023, the sales of Febuxostat tablets in public medical institutions in China were approximately RMB 0.777 billion.
