Simcere gets clinical trial approval for advanced solid tumor drug

Simcere Pharmaceutical Group Limited has received Clinical Trial Approval from China's National Medical Products Administration for SIM0609, a CDH17 Antibody-Drug Conjugate (ADC). The approval, granted on September 5, 2025, allows the company to commence clinical trials for SIM0609 in patients with advanced solid tumors. This anti-tumor drug candidate was independently developed by the group.

SIM0609 is described as a novel CDH17-targeting ADC, comprising a humanized monoclonal antibody linked to the group's proprietary novel topoisomerase I (TOP-I) inhibitor via a new hydrophilic cleavable linker. CDH17 is highly expressed in various cancers, including gastric, colorectal, and pancreatic cancers, making it a promising therapeutic target, especially for gastrointestinal carcinomas.

Simcere Pharmaceutical Group identifies as an innovation and R&D-driven pharmaceutical company, focusing on therapeutic areas such as neuroscience, anti-oncology, autoimmune, and anti-infection. The company has also established a "State Key Laboratory of Neurology and Oncology Drug Development."