Comprehensive Report on the Investigational Agent BL-M07D1 (Trastuzumab brengitecan)

I. Introduction to BL-M07D1 (Trastuzumab brengitecan)

A. Overview as an Investigational Antibody-Drug Conjugate (ADC)

BL-M07D1 is an investigational antibody-drug conjugate (ADC) engineered for the targeted delivery of a cytotoxic agent to tumor cells, thereby possessing potential antineoplastic activity.[1] ADCs represent a therapeutic class that combines the specificity of monoclonal antibodies with the potent cell-killing ability of chemotherapy drugs, aiming to enhance efficacy while minimizing systemic toxicity.

The International Nonproprietary Name (INN) assigned to BL-M07D1 is Trastuzumab brengitecan.[3] This nomenclature was proposed in the World Health Organization (WHO) INN List 129 in 2023 and subsequently recommended in INN List 91 in 2024, with the assigned INN Number 12677.[3] The adoption of an INN is a crucial milestone in the global development and identification of a pharmaceutical substance, facilitating clear communication among healthcare professionals and researchers worldwide. The "Trastuzumab" component within the INN immediately suggests that the antibody backbone is derived from or related to trastuzumab, an antibody well-known for targeting the Human Epidermal Growth Factor Receptor 2 (HER2).

Other identifiers for this compound include the code names BL M07D1 and BLM07D1.[1] Its Chemical Abstracts Service (CAS) registry number is 2761149-81-7, and it has been assigned the FDA Unique Ingredient Identifier (UNII) 5MHN3G4T8J.[3] Furthermore, BL-M07D1 is classified as a new molecular entity, indicating its novel chemical structure and therapeutic potential.[4]

B. Development and Originator Companies