Sugemalimab

Last updated

Sugemalimab
Monoclonal antibody
Type Whole antibody
Source Human
Target PD-L1, (CD274)
Clinical data
Trade names Cejemly
Other namesCS-1001, WBP-315
Routes of
administration
Intravenous
Drug class Antineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

Sugemalimab, sold under the brand name Cejemly, is a monoclonal antibody used for the treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy. [1] 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. [1]

Contents

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. [3] 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). [3] 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. [3] PD-L1 is overexpressed by many human cancer cell types. [3] PD-L1 binding to PD-1 on T-cells suppresses the immune system and results in immune evasion. [3] 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. [3] Anti-PD-L1 monoclonal antibody CS1001 mirrors natural immunoglobulin G4 (IgG4), potentially reducing immunogenicity and other toxicities. [3]

Society and culture

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. [1] [4] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH. [1]

Names

Sugemalimab is the international nonproprietary name. [5]

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References

  1. 1 2 3 4 5 "Cejemly EPAR". European Medicines Agency. 30 May 2024. Retrieved 1 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. "Cejemly PI". Union Register of medicinal products. 25 July 2024. Retrieved 28 July 2024.
  3. 1 2 3 4 5 6 7 "Sugemalimab (Code C154550)". NCI Thesaurus. 29 April 2024. Retrieved 1 June 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  4. "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024". European Medicines Agency (Press release). 31 May 2024. Retrieved 13 June 2024.
  5. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl: 10665/340680 .