The National Medical Products Administration (NMPA) has granted approval to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) for its drug oteseconazole (SHR8008), which will be used to treat severe vulvovaginal candidiasis (VVC). This marks a significant advancement in the treatment options for patients suffering from VVC.
Oteseconazole: A Selective Fungal Sterols 14 α Nor-(cyp51) Inhibitor
The Category 1 product, oteseconazole, is a novel oral small molecule that acts as a selective fungal sterols 14 α Nor-(cyp51) inhibitor. Its selectivity to fungus CYP51 is superior to that of common azole antifungals, offering a potentially more effective treatment option. This approval comes after a licensing deal with US firm Mycovia Pharmaceuticals Inc. in June 2019, which granted Hengrui Pharmaceuticals exclusive rights to clinical development, regulatory filing, manufacturing, and marketing in China for a total deal value of USD 108.5 million.
Broad Applications in Antifungal Treatments
The drug is indicated for the treatment and prevention of all diseases and symptoms related to fungal infections in humans and animals, including recurrent vulvovaginal candidiasis, onychomycosis, and invasive fungal infections. Oteseconazole was filed for marketing in China in January 2022, following the successful achievement of the primary endpoint in Phase III trials in 2021.-Fineline Info & Tech
