By Fineline Cube 
Huadong Medicine Co., Ltd. (SHE: 000963) announced today that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its novel antibody‑drug conjugate HDM2017 Injection. The decision allows the company to initiate a Phase 1 clinical trial to evaluate HDM2017 in patients with advanced malignant solid tumors.
What Is HDM2017?
- Targeted ADC – HDM2017 is the first antibody‑drug conjugate (ADC) designed to bind Cadherin‑17 (CDH17), a cell‑surface protein overexpressed in a range of solid tumors.
- Composition – The conjugate couples an anti‑CDH17 monoclonal antibody to a topoisomerase‑I inhibitor via a cleavable linker, achieving a drug‑to‑antibody ratio (DAR) of 4.
- Preclinical Profile – In vitro and in vivo studies demonstrate favorable druggability, robust safety margins, and potent antitumor activity against CDH17‑positive colorectal, pancreatic, and gastric cancer models.
FDA IND Approval
- Regulatory Milestone – The IND clearance confirms that the FDA considers the preclinical data sufficient to warrant human testing, marking a critical step toward clinical development.
- Phase 1 Trial Design – The first‑in‑human study will enroll patients with advanced, refractory solid tumors, evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy of HDM2017.
Strategic Implications
- First‑Mover Advantage – As the only CDH17‑targeted ADC in the pipeline, HDM2017 positions Huadong Medicine at the forefront of precision oncology.
- Global Expansion – FDA approval provides a launchpad for international collaboration and potential commercialization beyond China’s domestic market.
- Portfolio Growth – Success of HDM2017 could accelerate Huadong’s broader ADC development agenda, reinforcing its reputation as a leader in targeted cancer therapeutics.-Fineline Info & Tech