Simcere Pharmaceutical Group Limited (2096.HK) (Simcere), an innovative global biopharmaceutical company, announced today that Simcere Zaiming, an innovative oncology pharmaceutical company of Simcere has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of SIM0235, a potential first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, and MSD's anti-PD-1 therapy,  KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL).

This is a Phase 1 trial（SIM1811-03-TNFR2-102） to evaluate the safety, efficacy, pharmacokinetic/pharmacodynamic characteristics and immunogenicity of SIM0235 monotherapy and SIM0235 in combination with KEYTRUDA in patients with advanced solid tumors and CTCL.

Tumor necrosis factor receptor 2 (TNFR2) is a member of the tumor necrosis factor receptor superfamily and is primarily expressed on the surface of tumor cells and immune suppressive cells in the tumor microenvironment, leading to immune escape and tumor proliferation.

"Data generated from preclinical models demonstrate the capability of our potential first-in-class monoclonal antibody, SIM0235, in combination with KEYTRUDA, to clinically benefit patients with these cancers," said Dr. Bijoyesh Mookerjee, M.D., Chief Medical Officer, Oncology, Simcere Pharmaceutical Group. 

Under the terms of the agreement, MSD will supply KEYTRUDA and collaborate with Simcere Zaiming on this study. Simcere Zaiming retains all worldwide commercial rights to SIM0235.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA