Keymed Biosciences Receives IND Approval from China's NMPA for CDH17-Targeting ADC CM518D1 in Solid Tumors
Keymed Biosciences Inc. (HKEX: 02162) ("Keymed") has announced that its novel antibody-drug conjugate (ADC), CM518D1, has been approved for Investigational New Drug (IND) status by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China. The therapy, which is currently undergoing Phase I/II clinical trials, is being developed for the treatment of solid tumors, marking a significant milestone in Keymed’s oncology pipeline.
Introducing CM518D1: A First-in-Class CDH17-Directed ADC
CM518D1 is an innovative ADC designed to target Cadherin-17 (CDH17), a cell surface protein implicated in a variety of gastrointestinal malignancies. CDH17 is notably overexpressed in cancers such as colorectal, gastric, pancreatic, and esophageal, and is associated with cancer progression and metastasis.
This ADC combines a CDH17-specific monoclonal antibody with a cytotoxic payload, delivering its therapeutic agent directly to cancer cells. Preclinical models have shown that CM518D1 offers robust tumor-killing effects, including bystander cytotoxicity, excellent plasma stability, and broad anti-tumor activity across several solid tumor models. Toxicology studies also indicate a favorable safety profile and wide therapeutic window.
Ongoing Clinical Trials: Advancing Treatment for GI Tumors
Keymed is actively enrolling patients in Phase I/II trials in China to evaluate CM518D1’s safety, tolerability, and early signs of efficacy in individuals with advanced solid tumors. The company plans to expand development efforts to offer a more targeted, potent, and safer treatment option for patients suffering from gastrointestinal cancers globally.
Keymed’s ADC Innovation: Next-Generation Platform Technology
CM518D1 is part of Keymed’s proprietary antibody-drug conjugate development platform, which supports the creation of next-gen ADCs using novel payloads with varied mechanisms of action, hydrophilic linkers for enhanced release and stability, and engineered antibodies for improved target binding and pharmacokinetic properties.
To support this development, Keymed has built GMP-compliant manufacturing capabilities for both linker-payload and ADC drug substances. This infrastructure enables the company to accelerate clinical development and meet global standards in the fight against hard-to-treat cancers.