Sanofi/S Regeneron Dupixent Injection Approved for Clinical Trial in China for Treatment of Lichen Simplex

On November 26, the National Medical Products Administration's Center for Drug Evaluation (CDE) website announced that Sanofi (SNY.US) had been granted a new clinical trial implicit permit for Dupixent, which is intended to treat adult patients with moderate to severe chronic simplex dermatitis who have not responded well to external medication. Public information shows that Dupixent is currently undergoing a phase 3 clinical trial for simplex dermatitis in the global market. This is the first time it has been approved for clinical trials in China for this indication. Dupixent is an anti-IL-4Rα antibody approved by the FDA in the United States, developed by Sanofi and Regeneron (REGN.US). It can block the 2nd inflammatory pathway through the innovative "double target" mechanism of IL-4 and IL-13, reducing the pathological reaction of 2nd inflammation, and treat 2nd inflammation-related diseases from the mechanism. Studies have shown that IL-4 and IL-13 are key drivers of 2nd inflammation and play a crucial role in various inflammatory diseases. Sanofi and Regeneron are conducting two international multi-center phase 3 clinical studies (STYLE 1 and STYLE 2) to evaluate the efficacy and safety of Dupixent in improving the itch of chronic simplex dermatitis patients compared with placebo.