Innovent Biologics has received approval in its China homeland from the National Medical Products Administration (NMPA) for its new drug application for picankibart injection, indicated for the treatment of moderate-to-severe plaque psoriasis. Picankibart is a recombinant anti-IL-23p19 subunit monoclonal antibody (mAb) developed by Innovent. It functions by blocking the IL-23 signalling pathway to exert an anti-inflammatory effect.

The approval is based on positive results from the Phase III CLEAR-1 registrational study, which demonstrated that over 80% of subjects achieved a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) by week 16, a first for an IL-23p19 antibody in a global Phase III trial. The drug also features the longest maintenance dosing interval in its class, at once every 12 weeks.

The therapy aims to offer a new treatment option for an estimated 7 million individuals in China affected by psoriasis, a chronic, immune-mediated inflammatory disease. The domestic market for IL-23p19 inhibitors already includes three other approved drugs from Johnson & Johnson, China Medical System/Sun Pharma, and Boehringer Ingelheim.

According to PharmCube's NextBiopharm® database, picankibart is also under investigation in additional Phase III studies for psoriatic arthritis and a Phase II study for ulcerative colitis, indicating a broader development strategy for autoimmune conditions. Click here to request a free trial for NextBiopharm®.