By Fineline Cube 
China‑based Huadong Medicine Co., Ltd. (SHE: 000963) announced that its novel antibody‑drug conjugate (ADC), HDM2017 Injection, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials in patients with advanced malignant solid tumors. The approval marks a significant milestone for Huadong’s oncology pipeline and underscores the therapeutic potential of targeting Cadherin‑17 (CDH17) in solid‑tumor disease.
Product Profile
- Mechanism of Action – HDM2017 couples an anti‑CDH17 monoclonal antibody to a topoisomerase‑I inhibitor via a cleavable linker, with a drug‑to‑antibody ratio (DAR) of four.
- Target – Cadherin‑17 (CDH17), overexpressed in a subset of colorectal, pancreatic, and gastric cancers.
- Preclinical Success – Demonstrated potent antitumor activity in xenograft models of CDH17‑positive colorectal, pancreatic, and gastric cancers, coupled with an acceptable safety profile in animal studies.
Clinical Development
- NMPA Status – Received authorization to initiate Phase I/II trials in patients with advanced solid tumors.
- Trial Design – The upcoming studies will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy across multiple CDH17‑positive tumor types.
- Timeline – First‑in‑human dosing is expected in the first half of 2025, with subsequent enrollment phases planned thereafter.
Strategic Implications
- Portfolio Expansion – HDM2017 adds a differentiated ADC to Huadong’s oncology platform, complementing existing small‑molecule and biologic programs.
- Market Potential – CDH17 is a promising biomarker for several high‑prevalence cancers; successful clinical outcomes could position HDM2017 as a first‑in‑class therapy.
- Collaborative Opportunities – Huadong may seek partnerships or co‑development agreements to accelerate global regulatory approval and commercial rollout.-Fineline Info & Tech