Jiangsu Hengrui Pharmaceuticals (01276): Injection SHR-4394, HRS-5041 tablets, Zemisia sutu tablets (SHR 2554), and Rivolamine tablets have been issued with a "Drug Clinical Trial Approval Notification."

Jiangsu Hengrui Pharmaceuticals (01276) announced recently that Jiangsu Hengrui Pharmaceuticals Co., Ltd. (hereinafter referred to as the "Company") and its subsidiaries Chengdu Shendi Pharmaceutical Co., Ltd. and Shanghai Jiangsu Hengrui Pharmaceuticals Co., Ltd. have received approval from the National Medical Products Administration (hereinafter referred to as the "NMPA") to conduct clinical trials for the injection SHR-4394, HRS-5041 tablets, Tazemetostat tablets (SHR 2554), and Rivolumab tablets in the near future. The injection SHR-4394 is a biopharmaceutical developed independently by the company for the treatment of prostate cancer. To date, there are no similar products approved for sale domestically or internationally. As of now, the cumulative research and development investment for the injection SHR-4394 project is approximately 38.4 million yuan. HRS-5041 tablets are a novel, highly efficient, and selectively targeted AR PROTAC (androgen receptor protein degrading chimeras) small molecule developed by the company for the treatment of prostate cancer. HRS-5041 has a significant degrading effect on wild-type and the vast majority of mutant AR proteins. Compared to second-generation AR inhibitors, it has the potential to overcome drug resistance. Currently, there are no similar products approved for sale domestically or internationally. As of now, the cumulative research and development investment for the HRS-5041 tablets project is approximately 92.66 million yuan. Tazemetostat tablets are a new, highly efficient, and selectively targeted oral EZH2 inhibitor developed by the company, which was approved for sale in 2025 for the treatment of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) adult patients who have previously received at least first-line systemic therapy. There are similar products available internationally such as Tazemetostat (EZH2 inhibitor) and Valemetostat (EZH1/2 inhibitor) that have been approved for sale. According to the EvaluatePharma database, global sales of Tazverik totaled approximately 51 million US dollars in 2024. As of now, the cumulative research and development investment for Tazemetostat tablets project is approximately 217 million yuan. Rivolumab tablets are second-generation AR inhibitors with stronger AR inhibitory effects and no agonistic effects compared to first-generation AR inhibitors. The company's Rivolumab tablets were approved for sale in 2022 for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) patients with high tumor burden. There are several second-generation AR inhibitors available internationally such as Enzalutamide, Apalutamide, and Darolutamide. According to the EvaluatePharma database, global sales of similar products to Rivolumab tablets totaled approximately 11.037 billion US dollars in 2024. As of now, the cumulative research and development investment for Rivolumab tablets project is approximately 697 million yuan.