HENGRUI PHARMA (01276.HK): NMPA approves oteseconazole capsules for marketing in China for severe vulvovaginal candidiasis

NewTimeSpace News: On 3 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., has received the notice from the National Medical Products Administration (NMPA) approving the domestic registration and marketing of the Company's oteseconazole capsules. The product is a Class 4 chemical drug with a specification of 0.15g, and the approved indication is the treatment of severe vulvovaginal candidiasis (VVC), classified as a prescription drug. The application involves the transfer of an already-marketed overseas-produced drug to domestic production, with the overseas production approval number being: NMPA approval number HJ20230084.

Oteseconazole is a novel oral small-molecule selective fungal CYP51 inhibitor introduced by the Company from the US company Mycovia, which exerts its antifungal effect by highly specifically inhibiting the fungal CYP51 enzyme. The indication of treating recurrent vulvovaginal candidiasis was approved for marketing in the United States in 2022, and after being introduced by the Company, it was approved for marketing in China in 2023 for the treatment of VVC; this approval involves the transfer of the already-marketed overseas-produced drug to domestic production. Domestically and internationally, a number of similar products have been approved for marketing, including fluconazole, itraconazole and voriconazole. According to available data, the combined global sales of similar products to oteseconazole in 2025 were approximately USD 2.23 billion. As of the date of this announcement, the cumulative R&D investment in the oteseconazole capsules project amounts to approximately RMB 219 million (unaudited).

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.