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The long-term management of hyperuricemia and gout has long suffered from the pain point of limited medication options. As a new-generation selective xanthine oxidase inhibitor, febuxostat specifically blocks the active pathway of xanthine oxidase to reduce uric acid production in the body, breaking the limitation of allergic risk caused by the non-specific inhibition of traditional allopurinol. Currently, this drug is mainly indicated for the long-term treatment of hyperuricemia in gout patients, and is not recommended for people with asymptomatic hyperuricemia. It is particularly suitable for patients who are intolerant to allopurinol or have poor response to it, and has become one of the core clinical options for the chronic disease management of gout.

The domestic market size of febuxostat exceeded 3 billion yuan in 2022. With the continuous rise in the prevalence of gout and the increase in the penetration rate of chronic disease management, the market growth rate has remained at around 8% in recent years. After the implementation of the centralized drug procurement, the market share of the original research drug has continued to decline, and domestic generic drugs now account for more than 90% of the market share. The production side is dominated by pharmaceutical companies in Jiangsu and Zhejiang regions as the core suppliers. The maturity of the API production process is continuously improving, the overall market competition is sufficient, and clinical accessibility has been greatly improved.

The original research enterprise of febuxostat is Teijin Pharma, with the brand name "Feburic", and its Chinese compound patent expired in 2023. The main dosage form approved for the original research drug is tablet, with specifications including 20mg, 40mg and 80mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration, and is also listed in the FDA Reference Preparations Catalogue. At present, the febuxostat APIs of more than 30 domestic enterprises have obtained Grade A status through CDE registration, and there are more than 60 corresponding domestic preparation varieties approved for marketing, with sufficient supply for clinical substitution. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of febuxostat impurity reference standards, covering the reference materials required for the entire research chain including process impurities and degradation impurities. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises for process research and development, quality research and registration declaration.