By Fineline Cube 
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its first-in-class category 1 biologic drug HDM2012. This novel antibody-drug conjugate (ADC) is indicated for the treatment of advanced solid tumors.
Drug Profile
HDM2012 is a groundbreaking ADC targeting MUC-17 (Mucin-17). The drug is composed of an anti-MUC-17 monoclonal antibody, a topoisomerase I inhibitor payload, and a cleavable linker with a drug-to-antibody ratio (DAR) of 8. This innovative design enables precise targeting and delivery of the therapeutic payload to cancer cells.
Preclinical Results
Preclinical studies have demonstrated that HDM2012 exhibits favorable drug properties, safety, and efficacy. The ADC has shown potent antitumor activity across multiple tumor models, along with good tolerability in animal experiments. These positive results highlight the potential of HDM2012 as a promising therapeutic option for patients with advanced solid tumors.-Fineline Info & Tech