Core Insights - The company has received approval from the National Medical Products Administration for clinical trials of several new drugs, including SHR-4394, HRS-5041 tablets, Zemeituzumab tablets, and Rivolumab tablets [1][2] Group 1: SHR-4394 - SHR-4394 is a self-developed biopharmaceutical intended for the treatment of prostate cancer, with no similar products approved for sale domestically or internationally [1] - The total R&D investment for SHR-4394 has reached approximately 38.4 million yuan [1] Group 2: HRS-5041 Tablets - HRS-5041 is a new, efficient, and selective AR PROTAC small molecule aimed at treating prostate cancer, showing significant degradation effects on wild-type and most mutant AR proteins [1] - There are currently no similar products approved for sale domestically or internationally, with a total R&D investment of about 92.66 million yuan [1] Group 3: Zemeituzumab Tablets - Zemeituzumab is a new, efficient, and selective oral EZH2 inhibitor approved for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) who have received at least one line of systemic therapy [2] - Similar products include Tazemetostat and Valemetostat, with Tazverik's global sales projected to be approximately 51 million dollars in 2024 [2] - The total R&D investment for Zemeituzumab has reached about 217 million yuan [2] Group 4: Rivolumab Tablets - Rivolumab is a second-generation AR inhibitor with stronger AR inhibition and no agonistic effects, approved for the treatment of high-burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [2] - Competing products include Enzalutamide, Apalutamide, and Darolutamide, with global sales of similar products projected to be around 11.037 billion dollars in 2024 [2] - The total R&D investment for Rivolumab has reached approximately 697 million yuan [2]
恒瑞医药(01276):注射用SHR-4394、HRS-5041片、泽美妥司他片(SHR 2554)、瑞维鲁胺片获签发《药物临床试验批准通知书》