Jiangsu Hengrui Pharmaceuticals (01276): HRS-6208 capsules, HRS-6209 capsules, HRS-8080 tablets, HRS-1358 tablets, and HRS-5041 tablets have been approved to conduct clinical trials.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, the company and its subsidiaries Shanghai Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shandong Shengdi Pharmaceutical Co., Ltd., and Chengdu Shengdi Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration to conduct clinical trials for HRS-6208 capsules, HRS-6209 capsules, HRS-8080 tablets, HRS-1358 tablets, and HRS-5041 tablets. HRS-6208 is a new, efficient, and selective small molecule inhibitor that can effectively and selectively inhibit the phosphorylation activation of the target, affecting cell cycle and transcription activity, thereby inhibiting the proliferation of tumor cells and exerting an anti-tumor effect. Currently, there are no similar products approved for market domestically or internationally. As of now, the cumulative research and development investment in the HRS6208 project is approximately 38.14 million yuan. HRS-6209 is a novel selective CDK4 inhibitor that can effectively inhibit the CDK4/cyclinD complex and downstream signals, inducing tumor cell arrest in the G1 phase, thus exerting an anti-tumor effect clinically intended for the treatment of advanced solid tumors. Compared to CDK4/6 inhibitors, it improves the selectivity for the CDK6/cyclinD3 signaling pathway, which can improve the hematotoxicity associated with CDK4/6 inhibitors. Currently, there are no similar products approved for market domestically or internationally. As of now, the cumulative research and development investment in the HRS-6209 project is approximately 119.85 million yuan. HRS-8080 is a new, efficient, and selective oral estrogen receptor degrader (SERD). It can effectively and selectively degrade ER, inhibit ER activity and downstream signals, thereby inhibiting the proliferation of tumor cells intended for the treatment of ER-positive and ER-mutant breast cancer. As of now, the cumulative research and development investment in the HRS-8080 project is approximately 198.70 million yuan. HRS-5041 is a new, efficient, and selective AR PROTAC (androgen receptor-protein degrader targeting chimeric) small molecule developed by the company for the treatment of prostate cancer. HRS-5041 has a significant degrading effect on wild-type and most mutant forms of the AR protein, and compared to second-generation AR inhibitors, it has the potential to overcome resistance. Currently, there are no similar products approved for market domestically or internationally. As of now, the cumulative research and development investment in the HRS-5041 project is approximately 92.66 million yuan. HRS-1358 is a novel, efficient, and selective PROTAC molecule targeting estrogen receptor (ER) degradation developed independently by the company. It can effectively and selectively degrade ER, inhibit ER transcription activity and downstream signals, thereby inhibiting the proliferation of tumor cells and exerting an anti-tumor effect. Compared to traditional small molecule drugs, it can overcome target protein mutation resistance and have higher selectivity for the target protein. Currently, there are no similar drugs approved for market domestically or internationally. As of now, the cumulative research and development investment in the HRS-1358 project is approximately 96.01 million yuan.