Jiangsu Hengrui Pharmaceuticals (01276): Oxycodone Capsules Obtain Drug Registration Approval

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., recently received notification from the National Medical Products Administration, approving the registration and market launch of the company's Otorconazole capsules for domestic production. Otorconazole is a new oral small-molecule selective fungal CYP51 inhibitor introduced from Mycovia Pharmaceuticals in the United States, which can highly specifically inhibit the fungal CYP51 enzyme to exert its antimicrobial effects. Otorconazole was approved for the treatment of recurrent vulvovaginal candidiasis in the United States in 2022, and was approved for market launch in 2023 after being introduced by the company. This approval allows for the transfer of the already marketed foreign-produced drug to domestic production. There are also various similar products in the domestic and overseas markets, including fluconazole, itraconazole, and voriconazole, which have been approved for sale. According to queries, the global sales of similar products to Otorconazole are projected to total approximately $2.23 billion by 2025. To date, the cumulative research and development investment in the Otorconazole capsule-related project is approximately 219 million yuan (unaudited).