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HRS-8080 + dalpiciclib is a combination therapy under clinical investigation for the treatment of unresectable or metastatic breast cancer, particularly in subtypes including ER-positive and HER2-negative disease. HRS-8080, developed by Jiangsu Hengrui Medicine/Shandong Suncadia Medicine, is a small molecule drug candidate; detailed mechanism-of-action information for HRS-8080 is not publicly disclosed. Dalpiciclib (SHR6390) is a selective, orally administered cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that arrests cell proliferation by blocking phosphorylation of the retinoblastoma (Rb) protein, leading to cell cycle arrest in sensitive tumor cells. The combination is undergoing Phase I/II clinical trials to determine safety, tolerability, pharmacokinetics, and preliminary efficacy in advanced breast cancer patients[3]. These trials include patients with HR-positive, HER2-negative tumors and reflect the growing interest in combinatory targeted therapies for overcoming resistance and improving outcomes in solid tumors.
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