Anidulafungin

Invasive fungal infections have high mortality rate and narrow therapeutic window. Echinocandins, with the characteristics of targeting fungal cell walls and low host toxicity, have become the core option for deep antifungal therapy. As a representative of the third-generation echinocandins, anidulafungin non-competitively inhibits β-1,3-glucan synthase to destroy the structure of fungal cell walls, and has strong antibacterial activity against Candida species (including fluconazole-resistant strains) and Aspergillus species. It is clinically mainly used for the treatment of adult candidemia, candidal peritonitis, abscess and esophageal candidiasis, especially suitable for immunocompromised patients with combined hepatic and renal insufficiency, and no dose adjustment is required.

At present, the global market size of echinocandin antifungal drugs exceeds 2 billion US dollars, with a compound annual growth rate of around 7%. Among them, anidulafungin, due to its clinical safety advantage, has an increasing proportion of use in the field of severe nosocomial infection year by year. In terms of the domestic market, due to the previous original research patent protection, the supply of anidulafungin has long been dependent on imports, and the price is at a high level. As relevant patents expire, the R&D process of domestic generic drugs accelerates, and under the expectation of potential coverage by centralized procurement, the clinical accessibility is expected to be further improved, and the market size is expected to grow at a rate of more than 12% in the next three years.

The original research enterprise of anidulafungin is Eli Lilly and Company, with the original brand name Eraxis. Its core compound patent in the United States expires in 2024, and the Chinese compound patent has expired in 2022. The dosage form approved for the original product is injection, with specifications of 50mg/vial and 100mg/vial. It has been included in the FDA Reference Listed Drug Catalog, but has not been included in the *Catalogue of Reference Preparations for Chemical Drugs* in China yet. In terms of domestic API registration, there is no approved A-status registration number for anidulafungin for the time being. The original preparation has been approved for import in China, and no domestic generic preparation has been approved for marketing. (Data as of September 2024, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of anidulafungin impurity reference standards, covering all intermediate impurities, degradation impurities and enantiomers in the synthesis route. All products meet the requirements of relevant regulations of Chinese Pharmacopoeia and FDA. Most impurities are available from stock. In-stock orders placed before 16:00 can be shipped on the same day, fully meeting the testing needs of API R&D, quality research and consistency evaluation at all stages.