Caspofungin

Invasive fungal disease has a high clinical fatality rate and is difficult to treat, and it is an important cause of death in critically ill patients in departments such as hematology, ICU, and organ transplantation. Caspofungin is an echinocandin antifungal drug, which exerts its effect by non-competitively inhibiting fungal cell wall β-1,3-D-glucan synthase. It has no obvious toxic and side effects on mammalian cells, and its safety is significantly better than that of traditional amphotericin B preparations. Its indications include empirical treatment of suspected fungal infections in patients with neutropenia and fever, treatment of invasive aspergillosis that is ineffective or intolerant to other therapies, as well as Candida infections such as candidemia, intra-abdominal abscess, and pleural cavity infection. It is one of the first-line options for the treatment of severe fungal infections in adults and children over 3 months old.

In recent years, the global market size of antifungal drugs has expanded steadily, with echinocandins accounting for more than 30%. Among them, caspofungin is the echinocandin variety with the highest current sales, and its global market size was close to US$1.2 billion in 2023. In terms of the domestic market, the sales of caspofungin in public medical institutions exceeded RMB 2.7 billion in 2023, with an annual growth rate of more than 12%. At present, the domestic preparation market is co-occupied by original research drugs and generic drugs, and generic drugs from more than 10 enterprises have been approved for marketing. After the implementation of centralized procurement, the price has dropped by more than 80%, and clinical accessibility has been greatly improved, driving the continuous rise in demand for upstream API.

The original research enterprise of caspofungin is Merck, with the trade name Cancidas®. The expiration date of its core compound patent in the United States is 2024, and the Chinese compound patent expired in 2021. The main dosage form approved by the original research is injection, with specifications of 50mg and 70mg. It has been included in the Catalogue of Listed Chemical Drugs in China and the FDA Reference Preparation Catalogue, and is the reference preparation for domestic generic drug research and development. As of now, there are 15 registration entries of caspofungin API on the CDE API registration platform, among which 9 are in the status of "A" (approved for use in marketed preparations), and more than 20 domestic caspofungin for injection have been approved for marketing, all of which have passed or are deemed to have passed the consistency evaluation. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of caspofungin impurity reference standards. Most products are directly available from stock. Stock orders paid before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of the whole process of API R&D, quality research, and production release.