Posaconazole

Invasive fungal infection is one of the important inducing causes of death in immunocompromised populations. Existing antifungal drugs generally have clinical pain points of narrow antibacterial spectrum and frequent drug resistance. As a second-generation triazole antifungal drug, posaconazole exerts its antibacterial effect by inhibiting the synthesis of ergosterol in fungal cell membranes. Its antibacterial spectrum covers a variety of pathogenic fungi such as Candida, Aspergillus, Cryptococcus and Mucor, and it is currently one of the few effective therapeutic drugs for Mucor infection. Clinically, it is mainly used to prevent and treat invasive fungal infections in high-risk groups such as hematopoietic stem cell transplant patients, patients with neutropenia, and hematological tumor patients receiving immunosuppressive therapy, which can significantly reduce the infection incidence and mortality of these groups.

The global market size of antifungal drugs is growing steadily, and the market size had exceeded 17 billion US dollars in 2023, among which triazole drugs account for more than 40%. As a core variety of triazoles, the global market size of posaconazole exceeded 1.8 billion US dollars in 2023, and its market size in China exceeded 2.4 billion yuan, with a compound annual growth rate of more than 21% in the recent 5 years. In terms of competitive landscape, the original research product has long dominated the market. With the expiration of core patents, domestic generic drugs have been successively approved for marketing. At present, more than 10 enterprises have obtained the consistency evaluation for posaconazole preparations, and the winning bid price in centralized procurement has dropped by more than 70% compared with that of the original research product, greatly improving the drug accessibility.

The original research enterprise of posaconazole is Merck Sharp & Dohme, with the original trade name "Noxafil". The core compound patent of posaconazole expired in 2019 in the United States, and the compound patent expired in 2021 in China. The main dosage forms approved for the original research product include oral suspension, enteric-coated tablets and injection, among which the specification of oral suspension is 40mg/ml, the specification of enteric-coated tablets is 100mg, and the specification of injection is 300mg/16.7ml. All the original research dosage forms have been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by NMPA, and are also listed as FDA reference preparations. In terms of domestic API registration, there have been more than 20 registration numbers of posaconazole API up to now, among which more than 15 are in A status. A number of enterprises including the original research enterprise have had their posaconazole preparations approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D, production and quality control requirements of posaconazole, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of different scenarios such as drug declaration, quality research and routine inspection.