Keymed Biosciences Gets NMPA Approval for CM518D1 IND in Solid Tumor Treatment

Keymed Biosciences Inc., a biotechnology firm based in Chengdu, China, has announced a significant development in its ongoing efforts to combat cancer. The company has received approval from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) for CM518D1, a cutting-edge antibody-drug conjugate (ADC) aimed at CDH17. This drug is currently in Phase I/II clinical trials in China, targeting the treatment of solid tumors. This progress enhances Keymed's portfolio in oncology, reflecting its commitment to advancing innovative cancer therapies.

The newly approved CM518D1 is a sophisticated ADC that targets Cadherin-17 (CDH17), a member of the cadherin superfamily. CDH17 has emerged as a potential therapeutic target, particularly in gastrointestinal cancers, due to its high expression in cancers such as colorectal, gastric, pancreatic, and esophageal, where it plays a crucial role in tumor progression and spread.

CM518D1 is designed to deliver cytotoxic agents directly to cancer cells through a CDH17-specific monoclonal antibody, marrying the targeting precision of antibodies with the powerful cancer-killing effects of chemotherapy. Preclinical research has shown that CM518D1 has strong direct cytotoxic activity, a potent ability to kill neighboring cancer cells, and maintains stability in the bloodstream. Its efficacy against various solid tumor models and its promising safety profile with a broad therapeutic range highlight its potential as a powerful anti-cancer agent.

Keymed is actively conducting clinical trials to assess CM518D1's safety, tolerability, and initial effectiveness in patients suffering from advanced solid tumors. The company aims to refine its understanding of the drug's potential to offer a more targeted, effective, and safer treatment for patients with gastrointestinal cancers globally.

The development of CM518D1 is facilitated by Keymed's proprietary ADC platform, which supports the creation of next-generation ADCs with unique payloads, optimized linkers, and engineered antibodies. These advancements aim to enhance the stability and pharmacokinetics of the drugs, thereby increasing their effectiveness and reducing side effects.

To support these innovative developments, Keymed has established Good Manufacturing Practice (GMP)-compliant facilities dedicated to the production of linker-payloads and ADC drug substances. This strategic infrastructure enables Keymed to lead in the development of ADC therapies, addressing critical unmet medical needs for cancer patients around the world.

Keymed Biosciences Inc., listed on the Hong Kong Stock Exchange (HKEX: 02162), is dedicated to addressing urgent and unmet clinical needs by providing high-quality and affordable innovative therapies. The company was founded by medical and scientific experts with extensive experience in transforming scientific and technological innovations into commercial successes, both in China and internationally.