Keymed Biosciences' IND for CM518D1 Approved in China for Gastrointestinal Cancers

CHENGDU, China, April 24, 2025 -- Keymed Biosciences Inc. ("Keymed") has announced that its innovative antibody-drug conjugate (ADC), CM518D1, has received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This significant development allows the commencement of Phase I/II clinical trials in China, focusing on the treatment of solid tumors. This approval marks a pivotal moment in Keymed's commitment to advancing ADC drug development, bolstering its expanding therapeutic portfolio in oncology.

CM518D1 is an advanced ADC designed to target CDH17, a member of the cadherin superfamily. CDH17 has emerged as a noteworthy target in the treatment of gastrointestinal cancers. Research indicates that CDH17 is prominently expressed in various gastrointestinal malignancies, such as colorectal cancer, gastric cancer, pancreatic cancer, and esophageal cancer, and is implicated in tumor progression and metastasis.

The mechanism of CM518D1 involves delivering cytotoxic agents directly to tumor cells via a CDH17-specific monoclonal antibody. This approach harnesses the targeting precision of antibodies combined with the powerful cytotoxic effects of chemotherapeutics. Preclinical trials have shown that CM518D1 possesses significant direct cytotoxic activity, a potent bystander killing effect, and excellent stability in plasma. Additionally, CM518D1 has demonstrated outstanding anti-tumor effectiveness in a range of solid tumor models, alongside a favorable safety profile and a broad therapeutic window during toxicological assessments.

Keymed is actively progressing with Phase I/II clinical trials in China to assess the safety, tolerability, and initial efficacy of CM518D1 in patients with advanced solid tumors. Future research aims to develop a precise, efficient, and safe treatment alternative for individuals globally suffering from gastrointestinal cancers.

Keymed's ADC platform represents a new generation of proprietary ADCs, dedicated to pioneering drug development. The platform is equipped to develop next-generation ADCs with innovative payloads featuring diverse mechanisms of action, hydrophilic linkers optimized for stability and controlled drug release, and engineered antibodies with improved binding and pharmacokinetics.

In response to the demands of next-generation ADC development and clinical research, Keymed has established GMP-compliant facilities for the production of linker-payloads and ADC drug substances. This infrastructure solidifies Keymed's position as a leader in ADC therapeutic development, addressing unmet medical needs on a global scale.

Keymed Biosciences Inc. is a biotechnology company focused on addressing urgent unmet clinical needs. It is dedicated to offering high-quality, affordable, and innovative therapies for patients both in China and internationally. The company was founded by experts in the medical and scientific fields with extensive experience in translating scientific advancements into commercial solutions domestically and abroad.