Huadong Medicine subsidiary gets NMPA, FDA approval for novel ADC trials

On September 29, 2025, a wholly-owned subsidiary of Huadong Medicine received notice from the National Medical Products Administration (NMPA) approving the clinical trial application for HDM2017 injection. This approval permits clinical trials for HDM2017 as a monotherapy for advanced malignant solid tumors.

HDM2017 is a novel, first-in-class antibody-drug conjugate (ADC) targeting Cadherin 17 (CDH17) and possessing global intellectual property rights. This ADC combines an anti-CDH17 monoclonal antibody with a topoisomerase I inhibitor via a cleavable linker. The company also announced that the Phase I clinical trial application for HDM2017 for advanced malignant solid tumors was approved by the U.S. FDA in September 2025.

This development is expected to enhance Huadong Medicine's core competitiveness in the oncology treatment sector. However, the company noted that drug development involves substantial investment, long timelines, and inherent risks, with the ultimate market entry and competitive landscape remaining uncertain. The current progress is not expected to significantly impact the company's recent performance.