恒瑞医药: HRS-6208 胶囊、HRS-6209 胶囊、HRS-8080 片、HRS-1358 片、HRS-5041 片获批开展临床试验

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of several new drug candidates, indicating a significant advancement in its oncology pipeline and potential market opportunities in the pharmaceutical industry [1][2]. Group 1: Drug Candidates - HRS-6208 is a novel, selective small molecule inhibitor that effectively suppresses phosphorylation activation of its target, impacting cell cycle and transcriptional activity to inhibit tumor cell proliferation. No similar products have been approved in the market to date. The cumulative R&D investment for HRS-6208 is approximately 38.14 million yuan [1]. - HRS-6209 is a selective CDK4 inhibitor that induces tumor cell arrest in the G1 phase, aimed at treating advanced malignant solid tumors. It shows improved selectivity over CDK6/cyclinD3 signaling compared to existing CDK4/6 inhibitors, potentially reducing hematologic toxicity. The cumulative R&D investment for HRS-6209 is approximately 119.85 million yuan [1]. - HRS-8080 is a novel, selective oral estrogen receptor degrader (SERD) designed to treat ER-positive and ER-mutated breast cancer. The cumulative R&D investment for HRS-8080 is approximately 198.70 million yuan [2]. - HRS-5041 is a new, selective AR PROTAC small molecule aimed at treating prostate cancer, showing significant degradation of wild-type and most mutant AR proteins, with potential to overcome resistance compared to second-generation AR inhibitors. The cumulative R&D investment for HRS-5041 is approximately 92.66 million yuan [2]. - HRS-1358 is a targeted estrogen receptor (ER) degrading PROTAC molecule that can effectively degrade ER and inhibit its transcriptional activity, with the potential to overcome resistance due to target protein mutations. The cumulative R&D investment for HRS-1358 is approximately 96.01 million yuan [2].