CStone Pharmaceuticals has announced its CS3006, a small molecule inhibitor of mitogen-activated protein kinase (MEK), has received investigational new drug approval for clinical trials from the China National Drug Administration (CNDA). This comes only three months after the CNDA accepted the company’s new drug application.

The company’s chief executive officer Dr Frank Jiang said: “It’s a great honour 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.

“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.”

The company focuses on innovative cancer therapeutics, particularly immuno-oncology combination therapies. The RAS-RAF-MEK-ERK pathway is the main intracellular signalling pathway in most of the human body’s cells. The pathway regulates key cellular activities including cell growth, proliferation, survival and apoptosis. MEK1 and MEK2 are threonine protein kinases that act downstream of RAS and RAF to activate ERK. Inhibiting MEK can affect tumour cell survival, proliferation and differentiation.

CStone chief scientific officer Dr Jon Wang said: “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, it has demonstrated good pharmacokinetic properties as well as promising synergistic activity when combined with our anti-PD-1 antibody (CS1003).”

“All this 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.”

Three MEK inhibitors have been approved and marketed globally – Novartis’ Mekinist, Roche’s Cotellic and Array’s Mektovi.