Naftifine

Superficial mycosis is a highly prevalent infectious disease worldwide. Due to its high recurrence rate and protracted course, it exerts a long-term impact on patients' quality of life. Naftifine is a third-generation allylamine antifungal drug. It specifically inhibits fungal squalene epoxidase to block the synthesis of ergosterol in fungal cell membranes, and simultaneously causes the intracellular accumulation of squalene, exerting bactericidal and bacteriostatic effects through a dual mechanism. Compared with traditional antifungal drugs, it has the characteristics of strong bactericidal activity, high skin permeability and long post-antifungal effect. It is mainly used clinically for the treatment of tinea manuum, tinea pedis, tinea corporis, tinea cruris, tinea versicolor and cutaneous candidiasis, and the applicable population covers adults and pediatric patients without contraindications.

At present, the global market size of topical antifungal drugs has exceeded 8 billion US dollars, among which allylamine drugs account for nearly 25%, with a compound annual growth rate of 6.2% in the past three years. With lower drug resistance rate and higher clinical cure rate, naftifine's market share in dermatological antifungal drugs has been increasing year by year, and the annual growth rate of sales in domestic sample hospitals reaches 11.3%. In terms of competitive landscape, the current domestic preparation market is dominated by generic drugs, the supply of active pharmaceutical ingredients has been localized, only a small number of enterprises have obtained marketing licenses through CDE registration, and the overall supply concentration is relatively high.

The original developer of naftifine is Novartis Pharma Schweiz AG, with the original brand name "Naftin". Its core compound patent expired globally in 2009. The main dosage forms approved for the original drug are 1% topical cream and gel, covering two specifications of 15g and 30g. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. At present in China, naftifine APIs from 5 enterprises have obtained A status through CDE registration, and the approved preparation varieties include naftifine hydrochloride cream, naftifine hydrochloride solution and naftifine hydrochloride ointment. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for naftifine API. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which fully meets the full-process needs of pharmaceutical enterprises for R&D registration and quality control.