Hemay Biological has received in its China homeland National Medical Products Administration (NMPA) approval for mufemilast as the first domestically developed PDE4 inhibitor indicated for plaque psoriasis, based on Phase III trial showing 53.6% PASI-75 response versus 16.0% for placebo with 60mg twice-daily dosing. The small molecule modulates cAMP and cGMP levels, controlling inflammatory cytokine production with applications across inflammatory conditions. Hemay is conducting an additional Phase III trial in Behcet's disease following positive Phase II results demonstrating reduced oral ulcer counts and accelerated healing versus placebo.

Safety data showed 6.7% to 6.9% treatment discontinuation rates due to adverse events in the Behcet's disease trial, with majority events being mild severity. The approval represents a significant milestone for China's innovative drug development in dermatology and autoimmune diseases, addressing treatment gaps in chronic inflammatory conditions through a novel mechanism of action.

PharmCube's NextBiopharm® database shows that Mufemilast joins five globally approved selective PDE4 inhibitors including apremilast and roflumilast, with only apremilast currently marketed in China for psoriasis. Click here to request a free trial for NextBiopharm®.