SUZHOU, China, July 30, 2018 /PRNewswire/ — CStone Pharmaceuticals (CStone) today 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.”

About the MEK pathway

The RAS-RAF-MEK-ERK signal transduction pathway is among the most fundamental intracellular signaling pathways found in the majority of cells and is responsible for regulating key cellular activities such as cell growth, proliferation, survival, and apoptosis. MEK1 and MEK2 are serine/threonine protein kinases that act downstream of RAS and RAF to activate ERK. The inhibition of MEK can affect tumor cell survival, proliferation, and differentiation. Currently, three MEK inhibitors have been approved and marketed globally: Novartis’s MEKINIST® (trametinib), Roche’s COTELLIC® (cobimetinib) and Array’s Mektovi (binimetinib).

About CStone Pharmaceuticals

CStone Pharmaceuticals is a clinical stage biopharmaceutical company devoted to the development of innovative drugs. With a broad pipeline, the company engages in the development of cancer therapeutics with a special focus on immuno-oncology based combination therapies. All members of the management team are seasoned executives from top multinational pharmaceutical companies. CStone has successfully built up its core competency in clinical development and translational medicine. The company is backed by prestigious VC/PE funds via two financing rounds to date, raising $150 million in a Series A round in July 2016, followed by $260 million in a Series B round in May 2018. With an experienced team, a rich pipeline, a robust R&D model, and substantial funding, CStone is well positioned as the partner of choice for multinational pharmaceutical / biotech companies to develop drugs in China and the Asia-Pacific region.

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