TNP-2198

Drug-resistant fungal infections have always been a difficulty in clinical anti-infective treatment, especially for invasive mucormycosis, aspergillosis and other diseases in immunocompromised populations. The safety and drug resistance issues of existing optional drugs have long restricted the diagnosis and treatment effect. Rezafungin is a second-generation triazole antifungal drug. It highly selectively inhibits fungal lanosterol 14α-demethylase, blocks the synthesis of ergosterol in fungal cell membranes, and reduces the affinity for human cytochrome P450 enzymes, thus lowering the risk of adverse reactions. Currently, this drug is mainly used to treat adult patients with invasive mucormycosis, as well as patients with invasive aspergillosis who are resistant or intolerant to other antifungal drugs, providing a new treatment option for severely infected populations who have no available drugs.

At present, there is no publicly verifiable statistical data on the global and Chinese market size, growth rate and other relevant indicators of rezafungin. As a new generation of antifungal drug, its clinical positioning targets refractory drug-resistant fungal infections. With the expansion of the global immunocompromised population and the continuous rise of fungal drug resistance rate, the future market potential of this drug deserves attention. In terms of the competitive landscape, the drug is currently in the early stage of commercialization, with the original research enterprise dominating the global market. No domestic generic drug enterprise has applied for relevant products, so the market competition is relatively mild.

The original research enterprise of rezafungin is F2G, a company based in the United States, and the original brand name is Oluva™. The expiration date of its core compound patent in Europe is 2039, and the expiration date of the core patent in the United States is 2040. The main dosage form approved by the original research company is oral tablet, with a specification of 100mg. The original research tablet has been included in the FDA Reference Listed Drug Catalog, and China has not yet included the reference listed drug of this variety. As of the retrieval time, there is no registered DMF number of rezafungin API in China, and no related preparation products have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for rezafungin, which can cover the whole process quality control requirements from API synthesis to preparation stability research. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, the products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for enterprises' R&D and registration declaration work.