NANJING, China I March 14, 2023 I 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 trialSIM1811-03-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.

About SIM0235

SIM0235 (SIM1811-03 injection) is an investigational humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TNFR2 and blocks its activation by endogenous tumor necrosis factor (TNF), inhibiting the immunosuppressive function and proliferation mediated by TNFR2, to enhance the anti-tumor immune response. Additionally, the antibody has shown cytotoxic effect on TNFR2-expressing immune suppressive cells including regulatory T cells (Tregs) and bone marrow-derived suppressor cells via antibody-dependent cell cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). SIM0235 is currently being studied in patients with advanced solid tumors or cutaneous T-cell lymphoma (CTCL) in Phase 1 trials in China (SIM1811-03-TNFR2-101) and the US (SIM1811-03-TNFR2-102).

About Simcere Zaiming

Simcere Zaiming is an oncology biopharmaceutical company, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to solving unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has built an innovative R&D pipeline with differentiated clinical value. In addition to the company’s R&D portfolio, Simcere Zaiming has three innovative drugs, COSELA®, Endostar®, and Envafolimab®. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide.

About Simcere Pharmaceutical Group

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of “providing today’s patients with medicines of the future.” Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D and commercial stage collaborations have made it a strategic alliance partner with world leading innovative companies and research institutes.

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SOURCE: Simcere Pharmaceutical Group