China CDE has accepted for review a new drug application (NDA) seeking the approval of mufemilast, a PDE4 inhibitor developed by Hemay Pharma, for the treatment of plaque psoriasis. The NDA may be based on only one placebo-controlled randomized phase 3 trial, as the study was initiated before the approval of the standard therapy. The first PDE4 inhibitor, apremilast, was approved in China in 2021, which is 7 years after its approval in the United States. PDE4 pathway Mufemilast Mufemilast (Hemay005) is an orally active selective PDE4 inhibitor ( in vitro IC50 = 80–120 nM ), which is under evaluation in patients with plaque psoriasis, Behçet's disease, atopic dermatitis, ankylosing spondylitis, and ulcerative colitis. Hemay005 At ACR Convergence 2023, Hemay Pharma revealed the findings from clinical studies of mufemilast in patients with plaque psoriasis and Behçet's disease. In the phase 3 trial, mufemilast (60 mg BID) exhibited a PASI75 response of 53.6% compared to 16.0%
China Biotech XYZ Shares Updates Related to New Drug Development in China