Novartis files for clinical trials of CDK2 Inhibitor ECI830 in China

On October 27, the CDE website showed that Novartis' CDK2 inhibitor ECI830 had its clinical trial application accepted. This marks the fourth CDK2 inhibitor to file for clinical trials in China.

ECI830 is a CDK2 inhibitor currently undergoing Phase I/II clinical trials for HR-positive/HER2-negative breast cancer and other solid tumors in countries and regions including the United States, Japan, and South Korea.

According to media reports, there are 48 CDK2 inhibitors under development globally (counting only active new drugs), with 9 having entered the clinical stage. The most advanced among them is INCB0123667, developed by Incyte, which has initiated Phase III clinical trials for ovarian epithelial cancer.

Three CDK2 inhibitors have entered clinical stages in China, namely Tagtociclib (Pfizer), ARTS-021 (Abrev Biotechnology), and BG-68501 (BeiGene/ENSEM Therapeutics).