Jiangsu Hengrui Pharmaceuticals (01276): Rivilutamide Tablets Receives Drug Clinical Trial Approval Notice

Jiangsu Hengrui Pharmaceuticals (01276) has issued an announcement. Recently, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company") received the Drug Clinical Trial Approval Notice for Rivilutamide Tablets approved and issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"), and will commence clinical trials in the near future. Rivilutamide Tablets are a second-generation AR inhibitor. Compared with first-generation AR inhibitors, it has stronger AR inhibitory effects and no agonistic activity. The Company's Rivilutamide Tablets were approved for marketing in 2022 for the treatment of patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC). Currently, multiple second-generation AR inhibitors are marketed both domestically and internationally, including enzalutamide, apalutamide, and darolutamide. According to the EvaluatePharma database, the total global sales of products in the same category as Rivilutamide Tablets in 2025 are approximately US$12.89 billion. As of now, the cumulative R&D investment in Rivilutamide Tablets-related projects is approximately RMB 740 million (unaudited).