Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced the submission of a market approval filing for its Category 1 drug culmerciclib (TQB3616). The filing is for the use of culmerciclib in combination with fulvestrant for the treatment of hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in patients who have been previously treated with hormonal therapy.
Culmerciclib is a novel cyclin-dependent kinase 2, 4, and 6 (CDK2/4/6) inhibitor that exhibits a more potent inhibitory effect on CDK2 compared to abemaciclib. This filing is supported by the results of a Phase III study (NCT05375461). The enhanced CDK2 and CDK4 inhibitory activity of culmerciclib may offer a potential solution to overcome resistance issues encountered with other CDK4/6 inhibitors in clinical use.- Flcube.com
