Chong Kun Dang announced on Wednesday that its Dupixent (dupilumab) biosimilar, CKD-706, has received Phase 1 clinical trial approval from the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
With this green light, Chong Kun Dang aims to demonstrate the pharmacokinetic equivalence of CKD-706 to the original Dupixent in healthy adults across Europe. The company will conduct clinical trials to compare pharmacodynamics, safety, and immunogenicity.
Dupilumab is a human monoclonal antibody. It’s a biopharmaceutical that works by inhibiting signaling pathways, binding to a common receptor used by interleukins (IL)-4 and -13, which play a role in type 2 inflammatory responses.
The U.S. Food and Drug Administration (FDA) has approved this drug for eight indications, including atopic dermatitis, asthma, chronic rhinosinusitis, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD). The drug continues to broaden its therapeutic scope through ongoing indication expansions.
Dupixent’s global sales are projected to reach approximately $15 billion in 2024. Last year, sales were expected to hit around $18 billion. With the addition of new indications and an expanded age range, the market is forecast to grow to about $21 billion by 2032.
A spokesperson for Chong Kun Dang said the approval of the European Phase 1 clinical trial represents a major milestone in the global development of CKD-706. The spokesperson added that the company plans to demonstrate equivalence to Dupixent through accelerated clinical trials, with the goal of expanding treatment options for patients with inflammatory diseases worldwide.
Chong Kun Dang continues to expand its biopharmaceutical portfolio. The company recently secured Phase 1 clinical approval in Europe for its psoriasis treatment biosimilar CKD-704, building on its track record of developing the anemia treatment biosimilar Nesbel and the macular degeneration treatment biosimilar Lucenbese