SIMCERE PHARMA (02096) announced that on September 5, 2025, the company's independently developed anti-tumor candidate drug SIM0609, a CDH17-targeted antibody-drug conjugate (ADC), has received clinical trial approval notification from China's National Medical Products Administration to conduct clinical trials for advanced solid tumors.
SIM0609 is a novel antibody-drug conjugate targeting cadherin-17 (CDH17), composed of a humanized monoclonal antibody conjugated with the company's proprietary novel water-soluble cleavable linker and the company's independently developed novel topoisomerase I (TOP-I) inhibitor.
CDH17 is highly expressed in multiple types of cancer, including gastric cancer, colorectal cancer, and pancreatic cancer, demonstrating potential as a therapeutic target for advanced solid tumors, particularly gastrointestinal tumors.