Sugemalimab

Sugemalimab is an experimental monoclonal antibody intended for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy. It is an antineoplastic monoclonal antibody that potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 ligands.

It is a fully human monoclonal antibody directed against the immunosuppressive ligand, programmed cell death-1 ligand 1 (PD-L1; cluster of differentiation 274; CD274), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, sugemalimab specifically targets and binds to PD-L1, blocking its binding to and activation of its receptor, programmed cell death 1 (PD-1). This reverses T-cell inactivation caused by PD-1/PD-L1 signaling and enhances the cytotoxic T-lymphocyte (CTL)-mediated anti-tumor immune response against PD-L1-expressing tumor cells. PD-L1 is overexpressed by many human cancer cell types. PD-L1 binding to PD-1 on T-cells suppresses the immune system and results in immune evasion. PD-1, a transmembrane protein belonging to the immunoglobulin superfamily expressed on activated T-cells, is a negative regulator of the immune system that limits the expansion and survival of CD8-positive T-cells. Anti-PD-L1 monoclonal antibody CS1001 mirrors natural immunoglobulin G4 (IgG4), potentially reducing immunogenicity and other toxicities.

Legal status
In May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cejemly, intended for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy. The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.

Names
Sugemalimab is the international nonproprietary name.