AbbVie has announced that its IL-23 inhibitor, Skyrizi (risankizumab), has received regulatory approval in China for a second indication: the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response or intolerance to conventional or biologic therapy. The drug, which selectively blocks IL-23 by binding to its p19 subunit, was first approved in China in March 2025 for Crohn's disease.

The approval is based on positive results from two Phase III trials, INSPIRE and COMMAND. In the 12-week induction study, risankizumab demonstrated a significantly higher clinical remission rate compared to placebo. In the 52-week maintenance trial, both the 180mg and 360mg dose regimens were superior to placebo in sustaining clinical remission. UC is a chronic, immune-mediated inflammatory bowel disease with a rising incidence in China, significantly impacting patients' quality of life and carrying long-term health risks.

According to PharmCube's NextBiopharm® database, AbbVie is also developing the drug in China for psoriatic arthritis and plaque psoriasis. Click here to request a free trial for NextBiopharm®.