By Fineline Cube 
China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I/II study of its CM518D1, a CDH17-targeted antibody-drug conjugate (ADC), in patients with solid tumors. This marks a significant step in the development of targeted therapies for gastrointestinal cancers.
CM518D1: Mechanism and Innovation
CDH17 (Cadherin-17), a member of the cadherin superfamily, is an emerging therapeutic target in gastrointestinal cancers. CM518D1 delivers cytotoxic payloads precisely to tumor cells using a CDH17-specific monoclonal antibody. This ADC combines the specificity of antibodies with the potent cytotoxicity of chemotherapeutics, offering a targeted approach to cancer treatment.
Clinical and Preclinical Evidence
Preclinical studies have demonstrated that CM518D1 exhibits strong direct cytotoxic activity, potent bystander killing effects, and excellent plasma stability. The ADC has shown remarkable anti-tumor efficacy in multiple solid tumor xenograft models and a favorable safety profile with a wide therapeutic window in toxicological evaluations.-Fineline Info & Tech