CStone announces first patient dosed in Phase I study in China for MEK inhibitor CS3006

SUZHOU,China,Oct. 30,2018 -- CStone Pharmaceuticals (CStone) today announced the initiation in China of a Phase I clinical trial for CS3006,a small-molecule MEK1/2 inhibitor. A first patient has been successfully enrolled and dosed at the 307th Hospital of the Chinese People's Liberation Army in Beijing.

"CS3006 is a highly selective mitogen-activated protein kinase (MEK) inhibitor developed by CStone",commented CStone's chairman and Chief Executive Officer Dr. Frank Jiang. "We are very optimistic that current data for CS3006 compares favorably with other MEK inhibitors on the market currently. In addition,CS3006 is viewed as having great potential as part of combination therapy with CStone's other pipeline candidates. We will continue to work to explore the value of CS3006 to provide effective new treatment options for cancer patients."

Dr. Jason Yang,CStone's Chief Medical Officer,noted: "We completed patient enrollment in a first-in-human study for CS3006 initiated in Australia during the first-half of this year,a study that is progressing smoothly. This China Phase I bridging trial will further assess CS3006's safety and preliminary efficacy in Chinese patients with solid tumors,and provide a foundation for further development. Thanks to the support of all parties involved,we have been surprised by the progress of CS3006 in China and will continue to push forward to insure CS3006 can benefit Chinese patients as soon as possible."

The Phase I study will be led by Dr. Xu Jianming of the 307th Hospital of the Chinese People's Liberation Army,who said: "We are pleased to enroll the first patient in this study. We hope that this MEK inhibitor could provide patients a viable new treatment option either as a monotherapy or in combination with other immunotherapy drugs. We look forward to working together with CStone in assessing the safety and efficacy of CS3006 in patients with late-stage tumors."

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,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

CStone Pharmaceuticals is a China-based innovative biopharmaceutical company devoted to meeting patient needs,focused on development of innovative tumor drugs and immunotherapies. Established at the end of 2015,CStone has built a world-class management team with experience ranging across the drug development life cycle from clinical development to commercialization. Our international-standard clinical research and development team gained experience developing some of the world's best-selling anti-tumor drugs. In terms of business model,CStone's approach combines independent research,clinical development capabilities,and commercial partnering. The company has built one of the largest anti-cancer drug pipelines in China,with 14 anti-tumor drugs under research including independently developed and internationally partnered products. Exclusive cooperation and licensing agreements have been reached with Blueprint Medicine and Agios. CStone's capabilities have been recognized by partners and investors in Series A and B financing rounds that were record-breaking within the biopharmaceutical field at that time,raising a combined total of USD 410 million. CStone aims to become a leading Chinese biopharmaceutical company with international prestige and serve as the cornerstone for the future health of patients.

For more information about CStone Pharmaceuticals,please visit: www.cstonepharma.com.

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