Hengrui Pharmaceutical (600276.SH): Orteconazole capsules obtained drug registration approval

Zhitong Finance App News, Hengrui Pharmaceutical (600276.SH) issued an announcement. Recently, the company's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. received a notice from the State Drug Administration to approve the registration and listing of drugs produced by the company in the domestic production of orteconazole capsules. This medicine is used to treat severe vulvovaginal candidiasis (VVC).

According to reports, oteconazole is a novel oral small-molecule selective fungal CYP51 inhibitor introduced by the company from MyCovia in the United States. It can inhibit the fungal CYP51 enzyme in a highly specific manner and exert an antibacterial effect. The indications for orteconazole for the treatment of recurrent vulvovaginal candidiasis were approved for marketing in the US in 2022. After being introduced by the company, it was approved for marketing in 2023 to treat VVC. This time, it was approved to transfer drugs produced overseas that have already been marketed to domestic production. Various similar products such as fluconazole, itraconazole, and voriconazole have also been approved for marketing at home and abroad. According to inquiries, the total global sales volume of similar products of oteconazole in 2025 is about US$2.23 billion. Up to now, the total R&D investment for oteconazole capsule-related projects is about 219 million yuan (unaudited).