Chongkundang's Dupixent Biosimilar Receives First Phase 1 Clinical Trial Approval in Europe

CKD-706 Undergoing Clinical Trials in Healthy Adults

Chongkundang announced on January 14 that its biosimilar of Dupixent (ingredient name: dupilumab), 'CKD-706,' has received the first-ever Phase 1 clinical trial approval in Europe. This approval was granted simultaneously by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Image of Chongkundang headquarters building in Chungjeongno, Seoul. Chongkundang

The clinical trial will demonstrate the pharmacokinetic equivalence between CKD-706 and Dupixent in healthy European adults, and will also compare their pharmacodynamics, safety, and immunogenicity.

Dupilumab is a biopharmaceutical developed using recombinant DNA technology to mirror the structure of human antibodies. It works by binding to the receptor (IL-4Rα) commonly used by the immune modulators interleukin (IL)-4 and interleukin (IL)-13, which are involved in type 2 inflammatory responses, thereby inhibiting their signaling pathways. The U.S. Food and Drug Administration (FDA) has approved it for eight indications, including atopic dermatitis, asthma, chronic rhinosinusitis, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD).

A Chongkundang representative stated, "By rapidly advancing clinical trials and demonstrating equivalence with Dupixent at an early stage, we aim to provide a new treatment option for patients with inflammatory diseases worldwide."