CKD-706 (dupilumab biosimilar) / Chong Kun Dang - LARVOL DELTA

Chong Kun Dang Pharmaceutical Corp. said on the 14th that its Dupixent (ingredient name dupilumab) biosimilar CKD-706 received phase 1 approval from the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) (Chosun Biz) - "Accordingly, the company plans to conduct a trial in Europe on healthy adults to demonstrate the pharmacokinetic equivalence of CKD-706 and Dupixent and compare pharmacodynamics, safety, and immunogenicity....Dupixent currently has U.S. Food and Drug Administration (FDA) approval for eight indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and chronic obstructive pulmonary disease (COPD)..."

New P1 trial • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Chong Kun Dang has received Europe’s first phase 1 clinical trial approval for CKD-706, the company’s biosimilar of the blockbuster autoimmune disease treatment Dupixent (dupilumab), marking the official start of its global development program. (Korea Biomedical Review) - "Chong Kun Dang said Wednesday that it received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for the phase 1 clinical trial protocol for CKD-706...Following the approval, Chong Kun Dang plans to conduct a European-based clinical trial to demonstrate pharmacokinetic equivalence between CKD-706 and the originator drug Dupixent in healthy adults, as well as to assess pharmacodynamics, safety, and immunogenicity."

New P1 trial • Immunology • Inflammation