The clinical trial approval for SIM0609 (CDH17 Antibody-Drug Conjugate) issued by the National Medical Products Administration

CAR-T Digest - August 2020

08 September 2025: The clinical trial approval for SIM0609 (CDH17 Antibody-Drug Conjugate) issued by the National Medical Products Administration

Simcere Pharmaceutical Group announced that its CDH17-targeting ADC SIM0609 received clinical trial approval from China’s National Medical Products Administration to begin testing in advanced solid tumors
SIM0609 is an anti-tumor antibody-drug conjugate independently developed by Simcere
It combines a humanized monoclonal antibody with the company’s proprietary novel topoisomerase I inhibitor
The payload is attached through a newly designed hydrophilic cleavable linker
CDH17, the target of SIM0609, is highly expressed in cancers such as gastric, colorectal and pancreatic cancer, making it a promising therapy for advanced gastrointestinal tumors