Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study combining its CDK 4/6 inhibitor, Dalpiciclib (SHR6390), with HRS-1358 for the treatment of breast cancer. This marks a significant step in expanding the treatment options for breast cancer patients in China.
Dalpiciclib, the first domestically-developed cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor in China, was granted market approval with priority review status in December 2021. It is indicated for use in HR-positive and HER2-negative recurrent or metastatic breast cancer that has progressed after endocrine therapy, in combination with fulvestrant. Furthermore, the drug received marketing approval as an initial therapy in combination with an aromatase inhibitor for patients with HR positive, HER2 negative, locally advanced or metastatic breast cancer in June of the previous year.
HRS-1358, a PROTACT molecule targeting the estrogen receptor (ER), is designed to inhibit tumor cell proliferation and overcome mutation resistance of target proteins with higher selectivity compared to conventional small-molecule drugs. This potential first-in-class global candidate has no similar product listed worldwide, highlighting its innovative potential in the treatment landscape.- Flcube.com
