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CentryMed’s Recombinant Human Anti-EGFR-CD3 Enzyme-Controlled Bispecific Antibody Receives Clinical Trial Approval
  • source: CentryMed
  • author: CentryMed
  • 時邁藥業(yè)
    2025.07.23
          
September 12, 2024 — On September 12, 2024, CentryMed’s recombinant human anti-EGFR-CD3 enzyme-controlled bispecific antibody (CMDE005), developed based on the company’s proprietary bispecific antibody platform proBiTE, received clinical trial approval from China’s National Medical Products Administration (NMPA). CMDE005 is indicated for the treatment of various EGFR-positive advanced solid tumors.

         

CMDE005 is a recombinant human anti-EGFR-CD3 enzyme-controlled bispecific antibody for injection developed using CentryMed’s proprietary proBiTE platform. The drug offers advantages including:

  • High expression yield during production

  • High stability

  • Long half-life

Clinically, CMDE005 is expected to significantly improve drug safety and efficacy, reduce market costs, and address unmet medical needs. To date, no enzyme-controlled bispecific antibody product has been approved globally.

Recent reports indicate that two U.S.-based innovative biopharmaceutical companies, Janux and CytomX, have similar "enzyme-controlled" candidates in Phase I clinical development. These candidates have shown preliminary significant tumor control rates and favorable safety in advanced non-small cell lung cancer and pancreatic cancer, respectively, attracting widespread attention and anticipation in the global innovative drug field.

We believe the successful development of CMDE005—a convenient-to-use (direct intravenous infusion), broad-spectrum (distinct from individualized BAT therapies) EGFR×CD3 enzyme-controlled bispecific antibody—will provide additional therapeutic options and clinical benefits to a broad population of cancer patients.