Chong Kun Dang announced on the 14th that its Dupixent biosimilar “CKD-706” has received the first Phase 1 clinical trial approval in Europe from the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

CKD-706 is a biosimilar candidate of Dupixent (ingredient name: dupilumab), a blockbuster biopharmaceutical that is widely used worldwide for the treatment of atopic dermatitis and asthma. A biosimilar is a therapy that has equivalent efficacy, safety, and quality to the original biopharmaceutical and is attracting attention as an alternative that can improve treatment accessibility.

With this approval, Chong Kun Dang will conduct a clinical trial in Europe in healthy adults to confirm whether the pharmacokinetic profile of CKD-706 in the body is equivalent to that of Dupixent. Through this, the company plans to compare and evaluate pharmacokinetic equivalence as well as safety and immunogenicity, and to demonstrate its competitiveness as a biosimilar.

Dupixent is a human monoclonal antibody therapy that simultaneously blocks the signaling of interleukin (IL)-4 and IL-13, which are involved in type 2 inflammatory responses. It has been approved by the U.S. FDA for eight indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD). Its scope of application continues to expand through indication extensions and broadening of age groups.

A Chong Kun Dang official stated, “This European Phase 1 clinical trial approval signifies that the global development of CKD-706 has begun in earnest,” adding, “We will swiftly conduct clinical trials to demonstrate equivalence with Dupixent at an early stage and provide more cost-effective treatment options to patients with inflammatory diseases worldwide.”

Global sales of Dupixent reached approximately KRW 20 trillion in 2024 and are expected to grow to about KRW 24 trillion in 2025. With the addition of various indications, the market is projected to reach around KRW 28 trillion by 2032.

Building on its experience in developing the anemia treatment biosimilar “Nespel” and the age-related macular degeneration treatment biosimilar “Lucenbs,” Chong Kun Dang has been steadily expanding its biopharmaceutical business, most recently obtaining European Phase 1 clinical trial approval for the psoriasis treatment biosimilar “CKD-704.”

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