2021-07-27-世界卫生组织-INN_Proposed_List_125_245页_7mb

Summary of the Document

Core Content

The document provides information about International Nonproprietary Names (INNs) and their Denominations Communes Internationales (DCIs) for pharmaceutical substances, specifically focusing on Proposed INN List 125 and related DCI Proposées. It outlines the process for the World Health Organization (WHO) in selecting these names and the nature of the proposed substances, including their chemical structures, functions, and methods of production.

Key Information

• Proposed INN and DCI: The names listed are under consideration by the WHO for adoption as international nonproprietary names. These names are not yet officially recommended and do not imply any recommendation for use in medicine or pharmacy.

• Provisional Nature: These names are provisional and will not be revised or included in the Cumulative Lists of INNs unless officially recommended.

• Feedback Period: Any comments or formal objections to the proposed names must be submitted to the WHO within four months of publication, i.e., not later than 29 November 2021 for List 125.

• Publication Date: The list was published on 30 July 2021 in WHO Drug Information.

Main Points

1. acmucabtagenum autoleucelum / acmucabtagène autoleucel / acmucabtagén autoleucel

• Description: Autologous T cells obtained from peripheral blood mononuclear cells via leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD19.
• Function: Cell-based gene therapy (antineoplastic).
• Components of the CAR:
  • Extracellular antigen-binding domain (anti-human CD19, scFv FMC63)
  • Extracellular TCR recruitment domain (anti-human CD3ε, scFv UCHT1 [Y177T])
  • Membrane-anchoring co-receptor domain (CD4)
• Vector Features:
  • Flanked by 5' and 3' LTRs
  • Contains ψ packaging signal, RRE, cPPT, and WPRE
• Production:
  • Leukapheresis material enriched for CD4/CD8 T cells via immunoselection
  • Cultured in serum-free medium with IL-2 and IL-7
  • Activated using CD3/CD28/CD2 soluble activator
• Cell Characteristics:

  • 70% T cells, generally ≥99%

  • 10% viable CD3+TAC+ cells

2. adintrevimabum / adintrevimab / adintrevimab

• Description: Immunoglobulin G1-lambda2 monoclonal antibody targeting the receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) glycoprotein.
• Function: Antiviral.
• Structure:
  • Heavy chain: Homo sapiens IGHG1*01, G1m17, G1v21
  • Light chain: Homo sapiens IGLV3-6601, IGLJ201, IGLC2*01
• Post-translational Modifications:
  • Disulfide bridges located at specific positions
  • N-glycosylation at HCH2 N84.4
  • Fucosylated complex bi-antennary CHO-type glycans
  • C-terminal lysine clipping at HCHS K2

3. amubarvimabum / amubarvimab / amubarvimab

• Description: Immunoglobulin G1-kappa monoclonal antibody targeting the receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) glycoprotein.
• Function: Antiviral.
• Structure:
  • Heavy chain: Homo sapiens IGHG1*01, G1m17, G1v21
  • Light chain: Homo sapiens IGKV3-2001, IGKJ201, IGKC*01
• Post-translational Modifications:
  • Disulfide bridges at multiple positions
  • N-glycosylation at HCH2 N84.4
  • Fucosylated complex bi-antennary CHO-type glycans
  • C-terminal lysine clipping at HCHS K2

4. anselamimabum / anselamimab / anselamimab

• Description: Chimeric monoclonal antibody targeting human immunoglobulin light chain amyloid (AL) fibrils.
• Function: Elimination of immunoglobulin light chain amyloid deposits.
• Structure:
  • Heavy chain: Mus musculus VH, Homo sapiens CH2, CH3
  • Light chain: Mus musculus V-KAPPA, Homo sapiens CH1, CHS
• Post-translational Modifications:
  • Disulfide bridges at multiple positions
  • N-glycosylation at HCH2 N84.4
  • Fucosylated complex bi-antennary CHO-type glycans
  • C-terminal lysine clipping at HCHS K2

Additional Notes

• Chemical Formulas and CAS Numbers:
  • Each substance includes its chemical formula and CAS number for identification.
• Language Variations:
  • The names are provided in Latin, English, French, and Spanish to ensure international recognition.
• Feedback Mechanism:
  • A period of 4 months is allowed for feedback from any interested party.
• Provisional Nature of Names:
  • The WHO does not endorse or comment on the efficacy of the described uses.
  • These names are not included in the Cumulative Lists unless officially recommended.

Conclusion

The document outlines the provisional names for new pharmaceutical substances, emphasizing that they are not recommendations for medical use. It includes detailed chemical structures, molecular formulas, and post-translational modifications for each proposed name. The WHO encourages feedback to ensure the accuracy and appropriateness of these names.