Simcere Pharmaceutical Group Limited announced that, on January 29, 2022, Beijing time, SIM0235 (SIM1811-03 injection), a humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody independently developed by the Group, has obtained the Investigational New Drug (IND) approval issued by the U.S. Food and Drug Administration (FDA), which is intended to be used for clinical trials of advanced solid tumors and cutaneous T-cell lymphoma (CTCL). SIM0235 has obtained the clinical trial approval issued by the National Medical Products Administration, PRC on December 6, 2021. SIM0235 is a human immunoglobulin G1 (IgG1) humanized anti-TNFR2 monoclonal antibody.

It can specifically recognize the TNFR2 expressed on the cell surface and render strong killing of immune-suppressive TNFR2+ regulatory T cell (Treg) and myeloid-derived suppressive cell (MDSC) via Fc-mediated effective functions such as antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP). In the meantime, it blocks the interaction between endogenous tumor necrosis factor (TNF) and TNFR2 and inhibits TNFR2- mediated immunosuppressive functions and the proliferation of Treg and MDSC, thereby enhancing anti-tumor immune response. In addition, SIM0235 can specifically recognize TNFR2 expressed on the surface of tumor cells and trigger direct killing of TNFR2 highly-expressed tumor cells via Fc opsonization.