Oteseconazole

Invasive fungal diseases have long plagued the clinical anti-infection field due to their high mortality rate and rising drug resistance rate. As a second-generation triazole antifungal drug, oteseconazole exerts its effect by inhibiting 14α-demethylase, a key enzyme in the synthesis of ergosterol in fungal cell membranes. Compared with first-generation triazole drugs, it has a broader antibacterial spectrum, and has strong activity against Aspergillus and Candida species including drug-resistant strains, while carrying a lower risk of drug interactions. It is mainly used for the treatment of invasive aspergillosis and invasive candidiasis in adults, and can also be used for the empirical treatment of suspected fungal infections in patients with neutropenia accompanied by fever, providing a safer medication option for high-risk groups such as those with immunodeficiency and long-term use of broad-spectrum antibacterial drugs.

At present, the global market size of antifungal drugs has exceeded 15 billion US dollars, of which triazole drugs account for nearly 40%. As a new generation of core variety, oteseconazole has achieved a global market compound annual growth rate of 18.7% in the past three years. In terms of the domestic market, with the popularization of medical technologies such as immunotherapy and organ transplantation, the number of confirmed patients with invasive fungal diseases has increased year by year. Due to its outstanding clinical advantages, the sales volume of oteseconazole in domestic sample hospitals exceeded 230 million yuan in 2023. At present, the original research product still occupies a dominant position, and more than 10 domestic pharmaceutical companies have laid out the research and development of generic drugs, and market competition will gradually intensify after the patent expires.

The original research enterprise of oteseconazole is Amgen, and the original research trade name is Noxafil. The core compound patent expires in 2025 in the United States, and the Chinese compound patent expires in 2024. The main dosage forms that have been approved at present include oral suspension, enteric-coated tablets and injection, with specifications covering 40mg/ml (oral suspension), 100mg (enteric-coated tablets), and 300mg/16.7ml (injection). Its original research dosage forms have been included in the FDA Reference Listed Drug Catalog, and are also included in China's *Catalog of Reference Listed Drugs for Chemical Drugs*. According to the domestic API registration platform, 3 enterprises have obtained approval for registration of oteseconazole API (status A) at present, and the original research product and 4 domestic preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for oteseconazole, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference standard use needs of pharmaceutical enterprises in all links such as research and development and quality control.