Jiangsu Hengrui Medicine Receives NMPA Clearance for Multiple Clinical Trials of Oncology Drugs

Jiangsu Hengrui Medicine Receives NMPA Clearance for Multiple Clinical Trials of Oncology Drugs

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for a suite of drugs including HRS-2189, HRS-5041, HRS-1358, HRS-8080, SHR-8068, adebrelimab, and HRS-6209. The company is set to initiate an open, multi-center Phase Ib/II clinical study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of HRS-2189 in combination with various treatments for advanced unresectable or metastatic solid tumors.

Study Design and Combination Therapies
The study will evaluate HRS-2189 in combination with Fulvestrant, with or without HRS-6209, or in combination with HRS-6209 with or without HRS-8080, or with HRS-6209 with or without HRS-1358, or with abiraterone with or without prednisone, or in combination with HRS-5041, or with adebrelimab with or without SHR-8068 with or without chemotherapy, or with abiraterone plus bevacizumab. This comprehensive approach aims to explore the potential synergistic effects of these combinations in treating solid tumors.

Drug Profiles
HRS-2189 is a drug that regulates the expression of multiple oncogenes and is intended for the treatment of advanced malignant tumors. HRS-5041 is an androgen receptor-targeted PROTAC small molecule under development for prostate cancer. HRS-1358 is an estrogen receptor (ER)-targeted PROTAC molecule. HRS-8080 is an oral selective estrogen receptor degrader (SERD) being developed for ER positive and ER mutant breast cancer. Adebrelimab is a PD-L1 monoclonal antibody (mAb) approved in China for the treatment of first-line extensive stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. SHR-8068 is an in-licensed CTLA-4 mAb. HRS-6209 is a novel CDK4 inhibitor designed for the treatment of malignant tumors.-Fineline Info & Tech

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