Chong Kun Dang said on the 14th that its Dupixent (ingredient dupilumab) biosimilar CKD-706 received phase 1 clinical trial approval from the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
Accordingly, the company plans to conduct a clinical trial in Europe in healthy adults to demonstrate the pharmacokinetic equivalence of CKD-706 and Dupixent and to compare pharmacodynamics, safety, and immunogenicity.
This is the first time a Dupixent biosimilar has received phase 1 approval in Europe by Chong Kun Dang. Dupixent is a human monoclonal antibody therapy that blocks the signaling pathways of interleukin (IL)-4 and interleukin (IL)-13, key factors in type 2 inflammatory responses, and was developed by Sanofi of France and Regeneron Pharmaceuticals of the United States.
Chong Kun Dang is focusing on Dupixent's market potential. Dupixent has secured U.S. Food and Drug Administration (FDA) approvals for a total of eight indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and chronic obstructive pulmonary disease (COPD), and the indications are steadily expanding. Global sales reached about 20 trillion won in 2024, and are estimated to grow to about 24 trillion won this year.
A Chong Kun Dang official said, "With this phase 1 approval in Europe, the global development of CKD-706 has been set in motion," adding, "we will swiftly proceed with the trial to prove equivalence with Dupixent at an early stage."