Gelonghui, November 3rd丨Hengrui Pharma (01276.HK) announced that recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “the Company”) received the Clinical Trial Approval Notice for Reviralutamide tablets issued by the National Medical Products Administration (hereinafter referred to as “NMPA”), and will initiate clinical trials in the near future.
Reviralutamide tablets are second-generation AR inhibitors. Compared with first-generation AR inhibitors, they exhibit stronger AR inhibition without agonistic effects. The Company’s Reviralutamide 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 such as Enzalutamide, Apalutamide, and Darolutamide have been launched both domestically and internationally. According to a query of the EvaluatePharma database, global sales of products in the same class as Reviralutamide tablets totaled approximately USD 11.037 billion in 2024. To date, cumulative R&D investment related to Reviralutamide tablets has amounted to approximately RMB 693.09 million.
