Rinvoq(upadacitinib)
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太平洋医药日报(20260205):艾伯维Rinvoq递交欧美上市申请
Tai Ping Yang Zheng Quan· 2026-02-07 00:25
Investment Rating - The industry rating is neutral, indicating that the overall return is expected to be between -5% and 5% relative to the CSI 300 index over the next six months [9]. Core Insights - AbbVie has submitted regulatory applications for its JAK inhibitor Rinvoq for the treatment of non-segmental vitiligo to both the FDA and EMA, based on positive results from the Phase 3 Viti-Up clinical study [5]. - The pharmaceutical sector showed a slight increase of +0.18% on February 5, 2025, outperforming the CSI 300 index by 0.78 percentage points, ranking 8th among 31 sub-industries [4]. - Among sub-industries, hospitals (+0.81%), offline pharmacies (+0.74%), and medical R&D outsourcing (+0.49%) performed well, while other bioproducts (-0.99%), vaccines (-0.44%), and pharmaceutical distribution (-0.25%) lagged behind [4]. Sub-industry Summary - Chemical pharmaceuticals: No rating [3] - Traditional Chinese medicine production: No rating [3] - Biopharmaceuticals II: Neutral [3] - Other pharmaceutical industries: Neutral [3]
艾伯维(ABBV.US)Rinvoq斑秃疗法达后期临床主要终点 拟递交监管申请
智通财经网· 2025-08-22 06:34
艾伯维强调,此次试验结果与UP-AA临床项目首次平行研究的数据高度吻合,进一步验证了Rinvoq在斑 秃治疗领域的潜力。 目前该公司正推进相关监管申报工作,若获批上市,这款药物有望为全球数百万严重斑秃患者提供新的 治疗选择。 智通财经APP获悉,艾伯维(ABBV.US)周四宣布,其研发的斑秃治疗药物Rinvoq(upadacitinib)在两项关 键后期试验中达成主要目标。试验分别测试了每日15毫克和30毫克两种剂量方案,结果显示,用药24周 后,15毫克组有45.2%的患者实现至少80%的头皮毛发再生,30毫克组这一比例提升至55%,而安慰剂 组仅1.5%的患者达到类似效果。 除头皮毛发再生外,试验还验证了次要疗效终点:患者眉毛和睫毛的改善情况显著,且部分受试者头皮 毛发覆盖率超过90%。 安全性方面,两种剂量组的不良事件发生率与该药物已获批适应症的表现一致,其中15毫克组严重不良 事件发生率为1.9%,30毫克组为1.8%,均略高于安慰剂组的0.7%,但整体风险仍属可控范围。 ...