Simcere Pharmaceutical Group Limited announced 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(R) (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.

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(R) 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(R), Endostar(R), and Envafolimab(R). By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide.