Huadong Medicine’s first-in-class ADC HDM2012 gains FDA Phase I trial clearance

CAR-T Digest - August 2020

01 July 2025: Huadong Medicine’s first-in-class ADC HDM2012 gains FDA Phase I trial clearance

Huadong Medicine received FDA clearance to begin a Phase I clinical trial in the U.S. for its first-in-class ADC, HDM2012, aimed at treating advanced solid tumors
HDM2012 is an antibody-drug conjugate targeting MUC-17, consisting of an anti-MUC-17 mAb, a topoisomerase I inhibitor payload, and a cleavable linker with a DAR of 8
The ADC is designed to provide targeted therapy with high precision and efficacy
Preclinical studies showed strong antitumor activity and good tolerability across various animal models