Keymed Biosciences Announces Approval of IND for CM518D1 by the National Medical Products Administration of China for the Treatment of Gastrointestinal Cancers

CHENGDU, China, April 24, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") recently announced CM518D1, a CDH17-targeted antibody-drug conjugate (ADC) developed by Keymed, received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is currently undergoing Phase I/II clinical trials in China for the treatment of solid tumors. This milestone marks another breakthrough in Keymed's ADC drug development, further strengthening its innovative therapeutic pipeline in oncology.

CM518D1: a novel ADC drug targeting CDH17

CDH17 (Cadherin-17), a member of the cadherin superfamily, is an emerging therapeutic target in gastrointestinal cancers. Studies indicate that CDH17 is highly expressed in multiple gastrointestinal cancers including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, and plays a critical role in tumor invasion and metastasis.

CM518D1 delivers cytotoxic payloads precisely to tumor cells by a CDH17-specific monoclonal antibody, which combines the specificity of antibodies and the potent cytotoxicity of chemotherapeutics. Preclinical studies demonstrated that CM518D1 exhibits strong direct cytotoxic activity, potent bystander killing effect and excellent plasma stability. CM518D1 exhibits remarkable anti-tumor efficacy in multiple solid tumor xenograft models and a favorable safety profile and wide therapeutic window in toxicological evaluations.

Clinical development: providing a potential treatment regimen for gastrointestinal cancers

Keymed is currently conducting Phase I/II clinical trials in China to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. Future studies aim to provide a more precise, effective, and safe therapeutic option for patients worldwide with gastrointestinal cancers.

Keymed's ADC platform: a next-generation of proprietary ADC program for innovative drug development

Keymed's proprietary ADC platform has capabilities for developing next-generation ADCs with novel payloads (e.g., diverse mechanisms of action), hydrophilic linkers (optimized for stability and drug release) and engineered antibodies (enhanced binding and pharmacokinetics).

To meet the demands of next-generation ADC development and clinical research, Keymed has established GMP-compliant facilities for linker-payload and ADC drug substance production. This infrastructure positions Keymed at the forefront of ADC therapeutic development, helping to address unmet medical needs for patients worldwide.

About Keymed Biosciences

Keymed Biosciences Inc. (HKEX: 02162) is a biotech company focused on the urgent unmet clinical needs, and committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad.

SOURCE Keymed Biosciences