Erfonrilimab (KN046): A Comprehensive Monograph on a First-in-Class Bispecific PD-L1/CTLA-4 Immune Checkpoint Inhibitor

Section 1: Drug Profile and Executive Summary

1.1. Identification and Classification

Erfonrilimab is an investigational biopharmaceutical agent currently under extensive clinical development for the treatment of various malignancies. As a novel molecule in the field of immuno-oncology, its precise identification is critical for regulatory, clinical, and research purposes. The drug is classified as an antineoplastic agent and, more specifically, as an immune checkpoint inhibitor, belonging to the therapeutic category of monoclonal antibodies.[1]

Developed by Jiangsu Alphamab Biopharmaceuticals Co., Ltd., Erfonrilimab is most frequently identified by its development code name, KN046.[3] It represents a significant advancement in antibody engineering, being a first-in-class bispecific antibody designed to target two distinct immune regulatory pathways simultaneously.[2] The World Health Organization (WHO) has assigned it the Anatomical Therapeutic Chemical (ATC) code L01FF05, placing it within the class of monoclonal antibodies and antibody-drug conjugates used for cancer therapy.[1] The fundamental properties and identifiers of Erfonrilimab are summarized in Table 1.

Table 1: Erfonrilimab (KN046) Key Drug Identifiers and Properties

1.2. Executive Summary