Chong Kun Dang Pharmaceutical’s Dupixent Biosimilar CKD-706 Receives First Phase 1 Approval in Europe

[Financial News] Chong Kun Dang Pharmaceutical announced on the 14th that its Dupixent (ingredient name Dupilumab) biosimilar CKD-706 has received the first Phase 1 clinical trial approval in Europe from the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. With this approval, Chong Kun Dang Pharmaceutical plans to conduct a clinical trial in Europe in healthy adults to demonstrate the pharmacokinetic equivalence of CKD-706 and the reference product Dupixent, and to compare pharmacodynamics, safety, and immunogenicity.
Dupilumab is a human monoclonal antibody biopharmaceutical that binds to interleukin-4 receptor alpha (IL-4Rα), the receptor commonly used by Interleukin-4 (IL-4) and Interleukin-13 (IL-13), which are involved in type 2 inflammatory responses, thereby inhibiting the associated signal transduction pathways.
The drug is currently approved by the U.S. Food and Drug Administration (FDA) for eight indications, including atopic dermatitis, asthma, chronic rhinosinusitis, eosinophilic esophagitis, and Chronic Obstructive Pulmonary Disease (COPD), and it continues to expand its treatment scope through additional indications.
A Chong Kun Dang Pharmaceutical official said, “With this Phase 1 approval in Europe, the global development of CKD-706 is now in full swing,” adding, “By conducting the trial swiftly and demonstrating equivalence with Dupixent at an early stage, we aim to provide a new treatment option for patients with inflammatory diseases worldwide.”
Global sales of Dupilumab reached around 20 trillion won in 2024 and are expected to be about 24 trillion won in 2025, showing strong growth. With additional indications and expansion of the eligible age range, the market is projected to reach around 28 trillion won by 2032.
Building on its experience in developing the anemia treatment biosimilar Nesbell and the age-related macular degeneration treatment biosimilar LucenBS, Chong Kun Dang Pharmaceutical is continuously expanding its biopharmaceutical portfolio, most recently obtaining European Phase 1 approval for the psoriasis treatment biosimilar CKD-704.

vrdw88@fnnews.com Kang Jung-mo Reporter