Keymed Biosciences Achieves Regulatory Approval for CM518D1 to Treat Solid Tumors

Keymed Biosciences Announces Approval of CM518D1 for Solid Tumor Treatment

Keymed Biosciences Inc., a prominent biotechnology company focused on unmet clinical needs, has made significant strides with its latest development. The company announced that the National Medical Products Administration (NMPA) of China has granted them IND (Investigational New Drug) approval for CM518D1, an antibody-drug conjugate (ADC) targeting CDH17. This new drug is currently undergoing Phase I/II clinical trials in China for the treatment of advanced solid tumors.

A Milestone in Oncology

The approval of CM518D1 stands as a pivotal moment not only for Keymed but also for the field of oncology. This ADC, specifically designed to target CDH17, a member of the cadherin superfamily, represents a new therapeutic approach for gastrointestinal cancers, including colorectal, gastric, pancreatic, and esophageal cancers. Research indicates that CDH17 is overexpressed in various gastrointestinal tumors and plays a crucial role in cancer invasion and metastasis, making it a valuable target for treatment.

With CM518D1, Keymed aims to deliver cytotoxic agents directly to tumor cells using a monoclonal antibody that specifically binds to CDH17. This targeted approach combines the specificity of antibodies with the potent cytotoxicity of chemotherapeutics. Preclinical studies have demonstrated CM518D1’s strong cytotoxic effects and favorable safety profile, showing excellent efficacy in multiple models of solid tumor xenografts.

Clinical Development

Currently, the Phase I/II trials in China are set to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. Keymed's commitment to advancing this treatment may provide new options for patients suffering from gastrointestinal cancers, offering hope for a more effective and safer therapeutic alternative.

Keymed’s ADC Platform

The proprietary ADC platform developed by Keymed boasts the capability to create next-generation ADCs, introducing innovative payloads, optimized linkers for enhanced stability and controlled drug release, and specially designed antibodies to improve targeting and pharmacokinetics. This state-of-the-art technology places Keymed at the forefront of the ADC therapeutic landscape, addressing a critical gap in the treatment of cancer.

In response to the demands of ADC development and clinical research, Keymed has established facilities compliant with GMP (Good Manufacturing Practice) for the production of linker payloads and ADC active ingredients. This position enables Keymed to lead the way in advancing therapeutic options for patients globally.

About Keymed Biosciences

Keymed Biosciences Inc. (HKEX: 02162) is dedicated to addressing urgent clinical challenges through innovative, affordable, and high-quality therapies, both in China and internationally. Founded by a team of medical experts and scientists, the company aims to transform scientific and technological achievements into practical applications, ensuring that patients receive the best possible care.

In conclusion, with the approval of CM518D1, Keymed Biosciences is set to impact the treatment of solid tumors profoundly. This breakthrough reinforces their commitment to developing cutting-edge cancer therapies and underscores their role as a leader in the biopharmaceutical sector.