2024-02-28-世界卫生组织-INN_Proposed_List_130_306页_4mb

Summary of International Nonproprietary Names for Pharmaceutical Substances (INN) and Related Information

Core Content

The document provides information about the International Nonproprietary Names for Pharmaceutical Substances (INN), specifically focusing on the Proposed INN List 130 and related Recommended INN List 17. These names are under consideration by the World Health Organization (WHO) for use in pharmaceutical contexts. The inclusion of a name in the Proposed INN list does not imply any recommendation for its medical or pharmaceutical use.

Key Information

• Proposed INN List 130: The names listed are under review by WHO and are not yet officially recommended.
• Recommended INN List 17: This is a cumulative list of INNs, but the proposed names in List 130 are not included in it.
• Comments and Objections: Any person may submit comments or formal objections to the proposed names within four months of their publication in WHO Drug Information, which for List 130 is 30 June 2024.
• Publication Date: The proposed names were published on 01 March 2024.

Main Points

• The INN system is used to provide a unique, non-proprietary name for pharmaceutical substances to ensure clarity and standardization in global medical and pharmaceutical communication.
• Provisional Nature: Proposed INNs are not finalized and are not included in the Cumulative Lists of INNs. They are not revised and are only for informational purposes.
• WHO's Role: WHO does not endorse or comment on the use or efficacy of the substances, nor does it confirm the statements made by manufacturers regarding their potential applications.
• Language Versions: The document includes the names in Latin, English, French, and Spanish to support international use.

Examples of Proposed INNs

1. abenacianinum / abenacianine / abenacianina

   • Description: A diagnostic imaging agent with a complex chemical structure.
   • Chemical Name: A long, detailed chemical name with multiple substituents and functional groups.
   • Molecular Formula: Complex formula with multiple elements and positions.
   • CAS Registry Number: 2837159-88-1
   • Notes: The name is proposed for a substance with potential diagnostic imaging use.

2. adakitugum / adakitug / adakitug

   • Description: A monoclonal antibody targeting CXCL8 (IL8), produced in CHO cells, with glycoform alfa.
   • Chemical Name: Detailed structure of the heavy and light chains with specific amino acid sequences.
   • Molecular Formula: Complex formula.
   • CAS Registry Number: Not provided in the text.
   • Notes: The substance is an antineoplastic agent.

3. aldastotugum / aldastotug / aldastotug

   • Description: A monoclonal antibody targeting SIGLEC15, produced in CHO cells, with glycoform alfa.
   • Chemical Name: Detailed structure with heavy and light chain sequences.
   • Molecular Formula: Complex formula.
   • CAS Registry Number: Not provided in the text.
   • Notes: The substance is an immunostimulant and antineoplastic.

4. amlenetugum / amlenetug / amlenetug

   • Description: A monoclonal antibody targeting SNCA (alpha-synuclein), produced in CHO cells, with glycoform alfa.
   • Chemical Name: Detailed structure with heavy and light chain sequences.
   • Molecular Formula: Complex formula.
   • CAS Registry Number: 2850367-41-6
   • Notes: The substance is used for the treatment of alpha-synucleinopathies.

5. amostomigum / amostomig / amostomig

   • Description: A bispecific monoclonal antibody targeting CD47 and CD274 (PDL1), humanized, produced in CHO cells.
   • Chemical Name: Detailed structure with heavy and light chain sequences.
   • Molecular Formula: Complex formula.
   • CAS Registry Number: Not provided in the text.
   • Notes: The substance is a humanized monoclonal antibody with glycoform alfa.

Post-Translational Modifications

• Disulfide Bridges: Locations are specified for both heavy and light chains.
  • Intra-H (Heavy chain): 22-96, 143-199, 260-320, 366-424
  • Intra-L (Light chain): 23'-89', 135'-195'
  • Inter-H-L: 219-215'
  • Inter-H-H: 225-225", 228-228"
• N-glycosylation Sites:
  • Heavy chain: N84.4 at position 296, 296"
  • Light chain: Not specified in detail
• N-terminal Glutaminyl Cyclization: Q > pyroglutamyl (pE, 5-oxoprolyl) at H VH Q1: 1, 1"
• C-terminal Lysine Clipping: H CHS K2: 449, 449"
• Glycosylation Type: Fucosylated complex bi-antennary CHO-type glycans

Conclusion

The document outlines the provisional nature of the proposed INNs and emphasizes that WHO does not recommend or endorse the use of these substances. It provides detailed chemical and structural information for several substances, including their sequences, post-translational modifications, and glycosylation patterns. These names are intended to be used for research and identification purposes, with the potential for future recommendation if accepted.