Hengrui Medicine Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer.

Dalpiciclib, the first domestically-developed cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor in China, was granted market approval in China in December 2021 with priority review status. It is indicated for use in HR-positive and HER2-negative recurrent or metastatic breast cancer that has progressed following endocrine therapy, in combination with fulvestrant. In June last year, the drug was also approved for initial therapy in combination with an aromatase inhibitor for patients with HR-positive, HER2-negative, locally advanced, or metastatic breast cancer.

HRS8807 is a novel, potent, and selective oral estrogen receptor (ER) antagonist that can strongly and selectively bind to ER, inhibiting its activity and downstream signaling, which in turn inhibits tumor cell proliferation. To date, Hengrui has invested RMB 82.14 million in the R&D of HRS8807, and the company states that there is no similar product currently on the global market.- Flcube.com

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