CStone’s MEK Inhibitor CS3006 Receives IND Approval in China

CStone Pharmaceuticals (CStone) announced that its IND application for CS3006, a small-molecule inhibitor of mitogen-activated protein kinase (MEK), has been approved by the China National Drug Administration (CNDA) for clinical trials, just 3 months after the CNDA accepted the IND application.

“It’s a great honor for us that the CNDA has granted a special approval for CS3006, so that the clinical trials of CS3006 can be conducted in China soon,” noted Dr. Frank Jiang, Chief Executive Officer of CStone. “CS3006 is a highly selective MEK 1/2 inhibitor independently developed by CStone. It’s also the second candidate drug for clinical trials both in China and overseas following CS1003. Together, they laid a solid foundation for accelerating the global presence of CStone.”

“In a range of preclinical pharmacodynamic, pharmacokinetic, and toxicological experiments, we have already obtained abundant data about CS3006 to support the proposed clinical trials. In particular, CS3006 has demonstrated good pharmacokinetic properties as well as promising synergistic activity when combined with our anti-PD-1 antibody (CS1003),” said Dr. Jon Wang, Chief Scientific Officer of CStone. “All these data provided solid support for the quick CNDA approval of CS3006 clinical trial application. As next steps, we will accelerate the clinical trial process for CS3006 in China, work diligently to explore combination potentials of CS3006 with other drug candidates in our pipeline to develop novel and more effective therapies to benefit more patients.”