2021-10-30-世界卫生组织-New_INN_monoclonal_antibody_mAb_nomenclature_scheme_3页_99kb

New INN Monoclonal Antibody Nomenclature Scheme

This document introduces a new International Nonproprietary Name (INN) scheme for monoclonal antibodies (mAb), based on the INN Working Document 21.531 from November 2021. The scheme applies to all substances containing an immunoglobulin variable domain that binds to a defined target, with only immunoglobulin-derived pharmacologically active components.

The substances are divided into four groups based on their characteristics, independent of type, shape, or form:

• Group 1 covers unmodified immunoglobulins, including naturally occurring variants and specific modifications.
• Group 2 addresses modified or engineered monospecific immunoglobulins, such as those with point mutations or altered functions.
• Group 3 includes bi- and multi-specific immunoglobulins in any format or shape.
• Group 4 applies to all monospecific domains, fragments, or constructs that do not contain an Fc domain.

Suffixes are used in the naming, with the infix preceding the suffix to indicate the target class. The optional suffixes are:

• 'tug' for unmodified immunoglobulins
• 'bart' for artificial modified immunoglobulins
• 'mig' for bi- and multi-specific immunoglobulins
• 'ment' for fragments

Infixes are assigned based on the known mode of action and can include:

• -ami- for serum amyloid protein
• -ba- for bacterial targets
• -ci- for cardiovascular actions
• -de- for metabolic or endocrine pathways
• -en/i- for enzyme inhibition
• -fung- for fungal agents
• -gro/-os- for skeletal muscle growth factors
• -ki- for cytokine-related functions
• -ler- for allergen targets
• -sto- for immunostimulatory effects
• -pru- for immunosuppressive actions
• -ne- for neural targets
• -os- for bone-related uses
• -ta- for tumour targeting
• -toxa- for toxin neutralization
• -vet- for veterinary applications
• -vi- for viral targets

Notes highlight that antibody-drug conjugates are included without additional suffixes, and immunoglobulin fusions must have both domains derived from immunoglobulins. This scheme replaces the previous one and incorporates changes from INN Consultations, such as updates to infixes and grouping criteria.