Isavuconazole

Invasive fungal disease is a major cause of death in immunocompromised populations. The long-standing issues of hepatonephrotoxicity and drug resistance of existing antifungal drugs have long restricted clinical efficacy. As a new triazole antifungal drug, isavuconazole inhibits the biosynthesis of ergosterol in fungal cell membranes to destroy the structural integrity of fungal cells. It has potent antibacterial activity against a variety of pathogenic fungi such as Aspergillus, Mucor, and Candida, and its incidence of adverse reactions is significantly lower than that of traditional triazole drugs. It is mainly used for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients, and is a core first-line drug for departments such as hematology, infectious diseases, and transplantation to deal with high-risk fungal infections, especially suitable for patients who cannot tolerate other antifungal drugs such as voriconazole.

The global market size of isavuconazole exceeded US$1.2 billion in 2023, with a compound annual growth rate of 18.7% in the past five years. The growth is mainly driven by the increase in patients with hematological malignancies and the popularization of hematopoietic stem cell transplantation. The domestic market is still in the stage of rapid expansion. In 2023, the market size was approximately RMB 780 million, with an annual growth rate of over 45%. Currently, the original research product still occupies a dominant position. Three domestic enterprises have obtained approval for generic preparations, and the generic applications of more than 10 other enterprises are in the review stage. With the increase in the penetration rate of generic drugs and the expansion of medical insurance coverage, the domestic market size is expected to exceed RMB 2 billion in the next three years.

The original research of isavuconazole was jointly developed by Switzerland-based Basilea Pharmaceutica and Astellas, with the original brand name "Cresemba". The expiration date of its core compound patent in the European Union and the United States is 2027, and the expiration date of the compound patent in China is 2028. The main currently approved dosage forms are lyophilized powder for injection (specification 200mg) and oral capsule (specification 100mg), which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also reference preparations recognized by the FDA. In terms of domestic API registration, 4 enterprises have completed the CDE registration and public notification of isavuconazole API, and the preparation products of the original research enterprise and 6 domestic enterprises have been approved for marketing by the NMPA. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of isavuconazole impurity reference standards, covering all categories such as process impurities and degradation impurities. Most products are available from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and the FDA, and can fully meet the reference standard needs in various stages of API R&D, quality research, and declaration and registration.