Weekly Digest - September 2025
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - September 2025
22 September 2025: Huadong Medicine’s CDH17-targeted ADC HDM2017 IND application received FDA approval in the US
- The U.S. FDA approved Huadong Medicine’s IND application for HDM2017, a CDH17-targeted ADC, allowing Phase I clinical trials in advanced malignant solid tumors
- The U.S. IND approval, along with NMPA acceptance in China, strengthens Huadong Medicine’s global ADC pipeline and enhances its competitiveness in oncology drug development
- HDM2017 is a class 1 biological new drug with global IP rights, composed of an anti-CDH17 antibody linked to a topoisomerase I inhibitor via a cleavable linker (DAR=4)
- Preclinical studies showed HDM2017 has strong anti-tumor efficacy, safety, and bystander killing effects in CDH17-positive models
