恒瑞医药: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》

Core Insights - 恒瑞医药 has received approval from the National Medical Products Administration for clinical trials of several new drugs, including SHR-4394, HRS-5041, Zemeituzumab, and Rivolumab [1][2] Group 1: Drug Approvals and Clinical Trials - The company has been granted approval to conduct clinical trials for SHR-4394, a self-developed biopharmaceutical aimed at treating prostate cancer, with a total R&D investment of approximately 38.4 million yuan [1] - HRS-5041 is a new, efficient, and selective AR PROTAC small molecule also targeting prostate cancer, with a total R&D investment of about 92.66 million yuan [1] - Zemeituzumab is a novel oral EZH2 inhibitor approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in adults, with a total R&D investment of around 217 million yuan [2] - Rivolumab is a second-generation AR inhibitor approved for treating high-burden metastatic hormone-sensitive prostate cancer, with a total R&D investment of approximately 697 million yuan [2] Group 2: Market Context and Competitors - Currently, there are no approved products in the market for SHR-4394 and HRS-5041, indicating a potential first-mover advantage for the company [1] - Zemeituzumab faces competition from Tazemetostat and Valemetostat, which are already approved in the market, with Tazemetostat projected to generate global sales of about 51 million dollars in 2024 [2] - Rivolumab competes with several second-generation AR inhibitors, including Enzalutamide, Apalutamide, and Darolutamide, with projected global sales of similar products reaching approximately 11.037 billion dollars in 2024 [2]

Hengrui Pharma-恒瑞医药: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》 - Reportify