Jiangsu Hengrui Medicine Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080

China-based Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has announced that it received approval from the National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical study. This trial will evaluate the combination of dalpiciclib (SHR6390) and HRS-8080 in patients with ER+/HER2- irresectable or metastatic breast cancer.

HRS-8080: A Potential Breakthrough in Treatment

HRS-8080 is an in-house developed oral estrogen receptor (ER) degrader, aimed at treating ER-positive and ER-mutated breast cancer. The drug is considered a potential global first-in-class product and is also being studied as a monotherapy.

Dalpiciclib: Pioneering CDK Inhibition in China

Dalpiciclib is recognized as China’s first domestically-developed cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor. It received market approval in December 2021 with priority review status for HR-positive and HER2-negative recurrent or metastatic breast cancer, following endocrine therapy, in combination with fulvestrant.- Flcube.com

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