Huadong Medicine Receives FDA Approval for Clinical Trials of Innovative ADC HDM2020

Huadong Medicine Receives FDA Approval for Clinical Trials of Innovative ADC HDM2020

China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the US FDA for its innovative antibody drug conjugate (ADC) HDM2020. The drug targets fibroblast growth factor receptor 2b (FGFR2b) and is under development for the treatment of advanced solid tumors.

Preclinical Success
Preclinical studies have demonstrated that HDM2020 exhibits potent anti-tumor activity in target-positive pharmacodynamic models, including gastric cancer and squamous non-small cell lung cancer. The drug has shown favorable druggability and safety profiles, highlighting its potential as a promising therapeutic option.

NMPA Approval and Future Development
Last month, China’s National Medical Products Administration (NMPA) approved HDM2020 to enter clinical trials for advanced solid tumors. This latest approval from the US FDA further underscores the drug’s potential and paves the way for global clinical development.-Fineline Info & Tech