Core 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]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 信美悅® （匹康奇拜單抗注射液）獲中國國家藥品監督管理局 批准用於治療中重度斑塊狀銀屑病 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈，本集團自主研發的信美悅® （匹康奇拜單抗注 射液，重組抗白介素23p19亞基（「IL-23p19」）抗體，研發代號：IBI112）的新藥上 市申請（「NDA」）已獲中國國家藥品監督管理局（「NMPA」）批准，用於適合系統 性治療的中重度斑塊狀銀屑病成人患者。信美悅® （匹康奇拜單抗注射液）是首個 獲批的中國原研IL-23p19單克隆抗體。在同類生物藥中，信美悅® （匹康奇拜單抗 注射液）具有最長的維持期給藥間隔（每12週一次） ...