AbbVie(US:ABBV) Zhi Tong Cai Jing·2026-01-22 06:40Core Viewpoint - AbbVie announced the approval of Risankizumab (brand name: Skyrizi) for a second indication in China, aimed at treating adult patients with moderate to severe active ulcerative colitis (UC) who have inadequate response, loss of response, or intolerance to traditional or biologic therapies [1] Group 1: Product Information - Risankizumab is an IL-23 inhibitor that selectively blocks IL-23 by binding to the IL-23p19 subunit, which is involved in inflammatory processes related to various chronic immune-mediated diseases [1] - The approval for the new indication is based on positive results from two Phase III clinical trials, INSPIRE and COMMAND [1] Group 2: Clinical Trial Results - In the INSPIRE induction trial, Risankizumab significantly improved clinical remission rates at 12 weeks compared to placebo (20.3% vs 6.2%; adjusted between-group difference 14.0% [95% CI: 10.0%–18.0%]; P<0.001) [1] - In the COMMAND maintenance trial, both 180mg and 360mg maintenance doses showed significantly better clinical remission rates at 52 weeks compared to the placebo group (40.2% vs 37.6% vs 25.1%) [1] Group 3: Market Context - Risankizumab was first approved in China on March 10, 2025, for treating adult patients with moderate to severe active Crohn's disease who have inadequate response, loss of response, or intolerance to traditional or biologic therapies [1]