Micafungin

Invasive fungal infections have a high clinical fatality rate, and the hepatotoxicity and nephrotoxicity of traditional antifungal drugs restrict long-term medication options. The advent of echinocandin drugs has filled this clinical gap. As a representative variety of echinocandins, micafungin exerts its effect by non-competitively inhibiting the synthesis of β-1,3-D-glucan in the fungal cell wall. It has good antibacterial activity against Candida and Aspergillus, hardly interacts with other drugs, and has better hepatic and renal safety. It is mainly used for the prevention of fungal infections in patients undergoing hematopoietic stem cell transplantation, and the treatment of esophageal candidiasis and other invasive candidiasis, especially suitable for special infected populations with underlying diseases and hepatic and renal insufficiency.

At present, the global market size of micafungin has exceeded 1.2 billion US dollars, and the annual growth rate of the Chinese market remains above 15%, which is significantly higher than the overall market growth rate of antifungal drugs. In terms of the competitive landscape, the original research product still accounts for about 40% of the market share. With the successive approval of generic drugs after patent expiration, the proportion of domestic generic drugs continues to rise. At present, 7 domestic enterprises have passed the consistency evaluation for micafungin preparations, and the price of preparations has dropped by more than 70% after multiple rounds of provincial centralized procurement, further driving the demand growth of downstream active pharmaceutical ingredients (APIs).

The original research enterprise of micafungin is Astellas Pharma Inc. of Japan, with the trade name "Mycamine", and its core compound patent expired in China in 2021. The main dosage form approved by the original research is micafungin sodium for injection, with a conventional specification of 50 mg per vial. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. In terms of API registration, there are currently 8 micafungin sodium API registration numbers in China including that of the original research, among which 6 are in status A and can be used in association with domestic preparation applications. All the preparation varieties approved for marketing in China are micafungin sodium for injection. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of micafungin impurity reference standards. All series of products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day, which can fully meet the full-process needs of API R&D, quality research and compliance declaration.