This study is being done to test a microdevice, which is a small device designed to test drugs directly on skin conditions like atopic dermatitis (eczema) and psoriasis.
The small device, about the size of a grain of rice, has up to 20 tiny reservoirs that hold medications that are approved by the Food and Drug Administration (FDA) for atopic dermatitis and psoriasis. Very small amounts of these medications will be released into the skin (at levels in your body much lower than are typically used). In this study, the device will be tested to see if it's safe and works well for predicting how the skin will react to standard treatments. We will also look at how these reactions are connected to genetic information and overall treatment results.

开始日期2026-08-01

申办/合作机构

The University of California, San Francisco

NCT07448402

/ Not yet recruitingN/AIIT

National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System

The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:
* Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
* What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
* Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.

开始日期2026-05-01

申办/合作机构-

NCT07499232

/ Recruiting临床3期

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

开始日期2026-04-21

申办/合作机构

Janssen Research & Development LLC

100 项与利生奇珠单抗相关的临床结果

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100 项与利生奇珠单抗相关的转化医学

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100 项与利生奇珠单抗相关的专利（医药）

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777

项与利生奇珠单抗相关的文献（医药）

2026-12-31·European Clinical Respiratory Journal

Lung abscess as an adverse effect of Risankizumab

Article

作者: Kazi, Zarif ; Donenfeld, Thai ; Pascal, William ; Lewis, Toni-Ann ; Jesin, Stuart ; Clements, Kevin ; Ghimire, Samir

Background:

Risankizumab is used for prolongated duration by patients, necessitating further research to characterize the infectious risks involved.

Case Presentation:

A 30-year-old man on Risankizumab for psoriasis and alopecia presented with pleuritic chest pain, cough, hemoptysis, fever, and myalgias. Initial computed tomography (CT) scan showed a 4.9 × 7.7 × 6.1 cm irregular cavitary lesion in the medial right lower lobe with thickened walls and surrounding ground-glass opacification. Tuberculosis was ruled out with 3 negative acid-fast bacilli (AFB) samples and 2 negative samples for Mycobacterium tuberculosis and rifampin resistance assay (Xpert MTB/RIF). Empiric antibiotic therapy was initiated, though the patient remained persistently febrile and tachycardic despite reported symptomatic improvement. A repeat CT scan showed compression atelectasis of the right middle and lower lobes, and a large right pleural effusion with multiple air-fluid levels. The patient underwent a video-assisted thoracoscopic surgery (VATS) decortication. Pleural fluid culture grew methicillin-resistant Staphylococcus aureus, and sputum AFB culture from admission grew Mycobacterium avium three weeks after collection. The patient ultimately completed two weeks of oral doxycycline.

Conclusion:

Given the lack of notable risk factors for lung abscess, this case suggests a possible association with Risankizumab, which may have contributed to immunosuppression.

2026-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Risankizumab super responders in moderate-to-severe psoriasis: prevalence, predictors, and long-term maintenance in a multicenter, international, real-world cohort

Article

作者: Ibba, Luciano ; João, Ana Luísa ; Malagoli, Piergiorgio ; Torres, Tiago ; Dattola, Annunziata ; Gaiani, Francesca Maria ; Pimenta, Rita ; Leite, Luiz ; Fargnoli, Maria Concetta ; Pellacani, Giovanni ; Costanzo, Antonio ; Ferreira, Paulo ; Potestio, Luca ; Narcisi, Alessandra ; Mendes‐Bastos, Pedro ; Messina, Francesco ; Roda, Ângela ; Graceffa, Dario ; Assorgi, Chiara ; Valério, Joana ; Leal, Barbara ; Luz, Martim ; Orsini, Diego ; Paiva Lopes, Maria João ; Tommasino, Nello ; Ferreirinha, Ana ; Megna, Matteo

BACKGROUND/OBJECTIVES:

The concept of super responders (SRs) has gained increasing attention in psoriasis. However, evidence focusing exclusively on risankizumab remains limited. This multicenter, international, real-world study aimed to assess the prevalence, predictors, and long-term maintenance of SR status among patients with moderate-to-severe plaque psoriasis treated with risankizumab.

METHODS:

A retrospective observational study was conducted across 10 Italian and Portuguese referral centers. SRs were defined as patients achieving complete skin clearance (PASI 0) at week 20. Predictors of SR achievement and maintenance were assessed using multivariate logistic regression models at weeks 52, 104, and 130 (2.5 years).

RESULTS:

A total of 1372 patients were included (mean PASI 14.9 ± 8.2). At week 20, 610 (44.5%) achieved PASI 0 and were classified as SRs; 84.4% maintained this status at week 52 and 64.9% at 2.5 years. Biologic-naïve status (OR 1.65; p < 0.001) predicted SR achievement, whereas palmoplantar psoriasis (OR 0.58; p = 0.005) and higher BMI (OR 0.96; p = 0.011) negatively influenced it. Biologic-naïve status remained the strongest predictor of long-term maintenance (OR 2.87; p = 0.003).

CONCLUSIONS:

Risankizumab demonstrated high and sustained long-term effectiveness, inducing rapid and sustained complete clearance in a substantial proportion of patients.

2026-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Complete clearance of high-impact sites with risankizumab in patients with psoriasis: a 2-year real-world retrospective multicenter cohort study

Article

作者: Leite, Luiz ; Torres, Tiago ; Valério, Joana ; Pimenta, Rita ; João, Ana Luísa ; Paiva Lopes, Maria João ; Mendes-Bastos, Pedro ; Roda, Ângela ; Ferreira, Paulo ; Leal, Bárbara ; Contente, Margarida ; Ferreirinha, Ana ; Luz, Martim

OBJECTIVES:

Plaque psoriasis frequently involves high-impact anatomical sites such as the scalp, nails, and palmoplantar regions, which are associated with significant functional impairment and reduced quality of life. Evidence on the long-term effectiveness of biologic therapies in these locations in real-world settings remains limited. This study aimed to evaluate the real-world effectiveness and safety outcomes of risankizumab in achieving complete clearance of psoriasis affecting high-impact sites over a 2-year period.

METHODS:

We conducted a retrospective multicenter cohort study including adult patients with plaque psoriasis who initiated risankizumab between January 2020 and December 2023 across six dermatology centers. Effectiveness was assessed as the proportion of patients achieving complete clearance (Physician Global Assessment score of 0) in scalp, nail, and palmoplantar psoriasis.

RESULTS:

Among 459 patients treated with risankizumab, 232 (50.5%) had involvement of at least one high-impact site at baseline. Complete clearance at 2 years was achieved in 72.5% of patients with scalp involvement, 64.7% of those with nail psoriasis, and 52.2% of those with palmoplantar disease. Adverse events were infrequent and not treatment-limiting.

CONCLUSIONS:

These findings support the effectiveness of risankizumab in high-impact psoriasis sites in real-world clinical practice.

1,777

项与利生奇珠单抗相关的新闻（医药）

2026-06-28

·临研项目之管理

tulisokibart：一个全新炎症靶点的中国十字路口

DEEP DIVE · 全球首个 anti-TL1A 三期成功 tulisokibart：一个全新炎症靶点的中国十字路口默沙东抗 TL1A 单抗刚刚改写了 IBD 治疗的靶点版图——它拿下了 TL1A 这一类的第一个三期阳性。但要把这场全球胜利落到中国，真正的关卡才刚刚开始。机制 · 市场 · 注册 · 组织 · 准入全景拆解｜数据截至 2026 年 6 月 2026 年 6 月 22 日，默沙东宣布 tulisokibart（研发代号 PRA023 / MK-7240）在三期 ATLAS-UC 诱导研究中达到主要终点——这是抗 TL1A 这一全新机制类别在全球范围内的第一个三期阳性读出。对一个过去十年被反复质疑"能否成药"的靶点而言，这是分水岭式的一刻。而对中国市场，问题更具体：这条全球管线已经把中国装进了同一个跨国多中心研究里，但伴随诊断、基因数据跨境、医保准入这三道关卡，会决定它在中国究竟是"快速跟进的全球新药"，还是"卡在合规与商业化半途的迟到者"。本文从机制、市场、注册、组织、定价五个层面，拆解它的中国胜算。01 · 机制：为什么 TL1A 是 IBD 近十年最值得押注的新靶点 tulisokibart 是一款人源化抗 TL1A（基因名 TNFSF15）单克隆抗体，IgG1 亚型。它的作用方式直击炎症性肠病（IBD）的两个核心病理环节：TL1A 是一种促炎细胞因子，通过结合受体 DR3 同时驱动 T 细胞与固有免疫的炎症放大；更关键的是，TL1A–DR3 通路还独立参与肠道纤维化的形成。这正是它区别于现有所有 IBD 生物药的地方。无论是抗 TNF、抗整合素（vedolizumab）、抗 IL-12/23（ustekinumab）还是新一代抗 IL-23（risankizumab、mirikizumab），靶点都集中在"抗炎"这一维度。而克罗恩病患者真正的远期致残原因——肠道狭窄、瘘管、反复手术——本质是纤维化驱动的，现有疗法几乎无能为力。阻断 TL1A 意味着同时干预"炎症"与"纤维化"两条线，这是机制层面的真实差异化，而不是又一个抗炎靶点的换皮。更具想象力的是它自带的精准医疗叙事。tulisokibart 的二期研究配套了一套基于遗传的"应答可能性"检测——通过基因分型识别更可能对 anti-TL1A 起效的患者群。这让它成为 IBD 领域第一个尝试"伴随诊断 + 生物制剂"模式的资产。IBD 长期苦于"试错式用药"：患者往往要在多种生物制剂间反复切换才能找到有效方案，一套真正能预测应答的分子标签，临床价值不言而喻。值得多说一句的是 TL1A 这个靶点的"成药史"。它并非新发现——早在十多年前，全基因组关联研究就把 TNFSF15 锁定为 IBD 的核心易感基因，提示这条通路在疾病发生中扮演驱动角色。换句话说，TL1A 是少有的"先有人类遗传学验证、再有药物"的靶点，这与那些靠动物模型外推、最终在人体折戟的机制有本质区别。难点从来不在"该不该做"，而在"抗体能否在临床上把这条通路阻断得足够干净、足够安全"。tulisokibart 的二期到三期连续阳性，恰恰是用临床终点回答了这个悬置多年的问题——这也是为什么默沙东、赛诺菲、罗氏三家巨头会同时挤进同一条赛道。关键数据：从二期到三期的连贯证据链在二期 ARTEMIS-UC 溃疡性结肠炎研究中，全人群队列第 12 周临床缓解率为 26%，安慰剂仅 1%（P<0.001），内镜改善 37% 对 6%；而在生物标志物阳性富集人群中，缓解率进一步抬升至约 32%、安慰剂约 11%。诱导方案为静脉给药（第 1 天 1000mg，第 2、6、10 周各 500mg）。克罗恩病的二期 APOLLO-CD（开放标签）中，第 12 周内镜应答约 26%、临床缓解约 49%，且未见严重治疗相关不良事件。三期 ATLAS-UC 的诱导研究（Study 2）于 2026 年 6 月达到主要终点（第 12 周改良 Mayo 临床缓解），并拿下内镜改善、临床应答、组织-内镜黏膜愈合等关键次要终点，且明确表态"未发现新的安全性信号"。从二期到三期，疗效信号高度连贯——这对一个全新靶点尤为重要，因为新机制最大的风险恰恰是"二期惊艳、三期翻车"。tulisokibart 跨过了这道坎。不过需要清醒：这次达标的 ATLAS-UC Study 2 只是诱导研究，打中的是"三期第一枪"。诱导+维持的 Study 1 完整数据、长期维持疗效与完整安全谱、以及正式的监管申报包都还有待披露；克罗恩病的三期 ARES-CD 也仍在进行中。先发身位是真的，但这个资产的终局——尤其是长期维持获益与抗纤维化能否兑现——尚未落定。同靶赛道：领跑，但身后追兵密集抗 TL1A 资产公司最高阶段身位tulisokibart默沙东UC 三期阳性全球第一duvakitugTeva / 赛诺菲二期 b 阳性，三期在研紧随其后afimkibart罗氏UC 三期（拟 2027 申报）第二梯队本土 anti-TL1A 群多家国内企业临床早期为主追赶中全球已有约八个抗 TL1A 分子进入临床，赛诺菲为这一靶点连下重注，罗氏更是以约 71 亿美元首付（外加约 1.5 亿美元近期里程碑）收购 Telavant，拿下 afimkibart 的美国与日本权益（美日以外的商业化权利仍由辉瑞持有）。tulisokibart 的先发身位真实存在，但窗口期不会太长——duvakitug 的三期正在推进，afimkibart 计划 2027 年提交 UC 申报。先到三期阳性的红利，能否转化为先到市场、先占心智，取决于注册与商业化的执行速度。把视野放宽到全机制竞争，挑战更现实。tulisokibart 要超越的不只是同靶后来者，还有已经牢牢占据 IBD 治疗格局的现有标准——抗 TNF、vedolizumab、ustekinumab，以及来势汹汹的新一代抗 IL-23（risankizumab、mirikizumab）和口服小分子（JAK 抑制剂、S1P 调节剂如 etrasimod、ozanimod）。这些药物大多已在中国上市，疗效与安全性数据成熟，医生使用习惯已经形成。抗 IL-23 类目前是 IBD 生物药里增长最快、数据最亮眼的一档，tulisokibart 想要切下足够大的份额，单靠"全新机制"还不够，必须在难治人群、纤维化病变或精准应答这几个现有疗法的真实软肋上，拿出无可替代的临床证据。这也是它把适应症一路扩展到硬皮病相关肺病等纤维化疾病的底层逻辑：用"抗纤维化"这条别人讲不了的故事，去建立机制护城河。02 · 中国市场：一个被低估、正在快速膨胀的患者池很多人对中国 IBD 的第一反应是"患者不多"。这是一个正在迅速过时的判断。公开研究对中国 IBD 患者数的估计口径不一，但在全球疾病负担研究口径下已接近百万量级（有研究给出男女合计约 90 万人），且仍在快速增长，多项预测认为 2030 年前后将突破百万。绝对数虽不及欧美，但增速是全球最快的梯队之一。随着城市化、饮食西化和诊断能力提升，中国 IBD 正进入流行病学上的"复合累积"阶段。对一个 2027—2029 年才可能在华上市、需要长期用药的慢病资产来说，重要的不是今天的存量，而是上市后十年的增量曲线。更核心的是治疗缺口。中国中重度 UC/CD 患者即便用上现有生物制剂，一年期临床缓解率普遍只有三到五成，约三分之一的患者对抗 TNF 原发无应答，难治人群只能在不同机制间反复切换、甚至超说明书联用。而克罗恩病的纤维化狭窄，至今没有任何获批药物能逆转。这意味着 TL1A 的"抗炎 + 抗纤维化"双重机制，对应的恰恰是中国 IBD 临床最痛、最无药可用的那一段——这是 tulisokibart 在华价值叙事里最硬的一块基石。还有一个常被忽视的中国特征：生物制剂渗透率偏低。相比欧美中重度 IBD 患者较高的生物制剂使用比例，中国受限于诊断延迟、可及性与支付能力，相当一部分中重度患者长期停留在传统治疗（氨基水杨酸、激素、免疫抑制剂）上，未能及时升阶到生物制剂。这意味着市场不是"存量切分"那么简单，而是一个仍在快速渗透、天花板远未触及的增量市场。随着医保对 IBD 生物药覆盖的扩大和患者教育的深入，整个生物制剂蛋糕本身还在变大——后来者只要机制足够硬，依然有进场空间。问题在于，等 tulisokibart 真正在华上市时，这块蛋糕上已经站满了抗 IL-23 和口服小分子的争食者。 ⚠ 但有一个结构性短板：诊断基础设施。tulisokibart 的伴随诊断是一套尚未商业化的基因检测，全球范围内还没有任何 TL1A 配套诊断获批。在中国，这类基于遗传分型的检测只有头部中心具备能力，远未普及，更没有进入常规 IBD 诊疗路径。如果未来产品定位依赖生物标志物富集，"检测从哪来、谁来付费、如何注册"将是必须提前解的题。好在三期 ATLAS 采用了全人群入组而非强制富集，这在一定程度上为中国留出了"先全人群、再精准"的弹性空间。03 · 中国落地的真实风险地图把全球三期的胜利翻译成中国获批，要穿过七道实质性关卡。下面按风险量级逐一拆解。关卡一 · 伴随诊断在华落地　高风险 TL1A 遗传检测全球尚无任何获批产品。中国并非没有药物-伴随诊断联合开发/审评的路径（肿瘤领域已有成熟实践），但 IBD 这类遗传分型伴随诊断在中国缺少成熟落地先例，因此一旦标签策略与生物标志物绑定，其注册、本地实验室落地、收费与可及性都将成为前置瓶颈。当前的缓解项是三期走全人群入组，但"精准化"的长期叙事仍悬而未决。关卡二 · 人类遗传资源与基因数据跨境　高风险这是 tulisokibart 区别于普通单抗试验的最大合规摩擦。伴随诊断会产生人类基因数据，叠加跨国多中心、外方申办方的身份，需要走人类遗传资源国际合作审批（中外双方联合申请、多中心不得拆分），样本与基因数据出境还要面对信息备案、安全审查、数据出境安全评估的多重叠加。每一道都可能拖慢里程碑。务实解法是把遗传相关检测尽量本地化，规避材料与数据出境。关卡三 · 中国安全数据库体量　中等风险全球跨 UC、CD 乃至更多免疫病的安全暴露量很大。默沙东尚未公开披露中国亚组的具体例数，但若中国本土样本量有限，对一款需要长期使用的免疫抑制类生物药而言，长期感染、肿瘤等安全信号的中国证据可能偏紧，递交时或需更多依赖全球安全数据库支撑，并提前与监管沟通可接受的中国暴露量底线。关卡四 · 头部中心患者争夺与筛选失败　中等风险中国中重度 IBD 注册研究异常拥挤：mirikizumab、risankizumab、etrasimod 以及多个国产生物药都在抢夺同一批头部消化中心的患者池。叠加内镜确认活动度、既往生物制剂洗脱、达到基线阈值等严格入排，筛选失败率本就偏高。若再引入基因富集，筛败会进一步抬升、入组周期拉长。关卡五 · 境外主证据接受度　正向因素这是少有的明确利好。中国已经在同一份 ATLAS-UC 全球协议的跨国多中心研究内，UC/CD 是全球高度同质化的疾病，单抗类药物的种族敏感性内在偏低（同类 IBD 单抗在东亚的疗效与全球一致）。在国际人用药品注册技术要求之下，"境外主证据 + 中国亚组一致性"是可被较高程度接受的组合，无需另起独立的中国试验。关卡六 · 加速通道获取　中等偏正向全球首创机制 + 中重度 IBD 经治失败的真实缺口，使它具备申请突破性治疗与优先审评的良好基础。可参照的信号是：近年中国对创新 IBD 生物药的接纳度明显提升——古塞奇尤单抗 2025 年 5 月成为中国首个治疗 UC 的 IL-23 抑制剂，其克罗恩病更是拿到全球首批并落地中国。监管环境对创新 IBD 资产是友好的，关键在于以中国注册队列数据把握好申请时点。关卡七 · 医保与院内准入　中等风险作为后上市的新机制资产，中国药物经济学与预算影响证据包还需从零搭建。IBD 生物药已有 vedolizumab、ustekinumab 等通过医保谈判与双通道落地的先例，路径成熟，但新品入院、纳保仍有滞后期，定价更要直面同类竞品越来越激烈的价格压力。04 · 默沙东的算盘：免疫管线对冲 K 药悬崖理解 tulisokibart 的优先级，必须放到默沙东的全局里看。Keytruda（K 药）即将在 2028 年前后面临专利悬崖，默沙东最大的战略命题是"后 K 药时代的增长引擎从哪来"。免疫炎症是其多元化的核心方向之一，而 tulisokibart 正是这条线上的旗舰资产。 2023 年，默沙东以约 108 亿美元收购 Prometheus Biosciences，核心买的就是这个 PRA023。如今它不仅在 UC、CD 上推进三期，还把适应症扩展到系统性硬化症相关间质性肺病、类风湿关节炎、银屑病关节炎、中轴型脊柱关节炎、化脓性汗腺炎等二期项目，合计覆盖七个适应症——默沙东称其为当前抗 TL1A 类中开发布局最广的资产。这是把一个 IBD 资产升级为"平台型免疫管线"的打法，也意味着它的全球安全数据库会随适应症扩张而快速增厚，反过来支撑中国注册。对中国而言，默沙东有现成的本土能力底盘：成熟的注册团队、多个创新药在华获批与优先审评的经验、完整的药物警戒与商业体系。它经收购全资持有全球权益，无需本地引进或合作。真正的短板不在"能力"，而在"专科"——IBD/消化是默沙东中国相对新建的商业战线，医学事务与专科市场准入需要时间搭建。据公开试验登记信息，中国多家头部消化中心被纳入了这项全球三期研究，说明总部确实把中国当作关键波次市场之一，而非事后补登。从节奏上看，中国是在三期阶段才搭上这趟全球列车的——早期人体研究与概念验证都在海外完成，中国没有参与剂量探索，而是直接沿用全球已确定的诱导维持方案进入注册研究。这种"后期加入"模式的好处是省去了重复早期开发、风险已被海外数据大幅消化；代价则是中国在全球研究中的样本占比有限、起步偏晚，需要在监管沟通中主动论证中国亚组的代表性与一致性。换言之，中国想从"参与全球研究"走到"中国快速获批"，中间还隔着一整套主动的注册运作，不会因为身在全球研究里就自动兑现。默沙东能否把这条新专科战线的中国节奏压缩到与美欧首批尽量接近，是决定这个资产中国天花板的关键变量之一。05 · 中国价值重构：把"全球新机制"讲成"中国刚需" 一个全球资产要在中国立住，不能只复述全球叙事，而要重构出中国特异性的价值锚点。tulisokibart 有三个可以发力的方向：其一，难治与纤维化型 CD 的中国负担。中国克罗恩病以年轻男性、回结肠型、易狭窄穿透为特征，纤维化致残和反复手术的负担尤其重。抗纤维化机制如果能在中国人群中拿到哪怕是探索性的获益信号，就能讲出一个现有任何疗法都无法替代的故事。其二，东亚遗传背景与生物标志物。TNFSF15 本就是东亚人群 IBD 的主要易感基因之一，这意味着 TL1A 通路在中国患者中的相关性可能更高，生物标志物阳性比例也可能不低于西方人群。这是一个值得用中国数据去验证、并可能反向增强全球叙事的科学假设。其三，头部中心与 KOL 网络。中国 IBD 诊疗高度集中在少数国家级消化中心，PI 网络成熟稳定，关键专家已作为研究者参与全球三期。这种"患者集中、专家集中、证据集中"的结构，反而让一个需要精准识别患者的资产更容易在中国找到落点。06 · 标签与准入：先全人群拿证，再谈精准溢价基于三期全人群阳性的结果，最稳健的标签策略是先争取与全球一致的中重度 UC（随后 CD）完整适应症、全人群获批，把"中国首个抗 TL1A"的先发心智牢牢占住；再以 TL1A 新机制和抗纤维化的差异化，去支撑高于普通生物类似物的价值定价。生物标志物不必作为获批门槛，而应作为上市后精准用药、提升应答与卫生经济价值的增值工具——这样既规避了伴随诊断在华注册的前置风险，又保留了精准化的长期想象空间。准入端要打提前量。考虑到 IBD 生物药已是医保谈判与双通道的成熟品类，默沙东应在上市前就启动中国药物经济学证据的搭建，并直面同类竞品的价格下行压力——在一个 mirikizumab、risankizumab、国产生物药轮番降价的赛道里，"新机制"能换来多少价值溢价，将直接决定这个资产在中国的商业天花板。这里有一个绕不开的张力：创新机制的溢价诉求，与中国医保"以量换价"的谈判逻辑天然冲突。后上市意味着进入医保目录时，前面已经有多款 IBD 生物药完成谈判、把价格锚点压到了相当低的水平，新进入者很难单凭"全球首个抗 TL1A"就要到显著更高的价格。破局的关键，是把价值证据从"我是新机制"升级为"我在特定人群里不可替代"——比如生物制剂经治失败者的再缓解、纤维化型克罗恩病的疾病修饰、或精准人群中更高的应答持久性。只有把卫生经济价值锚定在现有疗法真正做不到的地方，才能在价格谈判桌上守住溢价空间，否则就会沦为又一款"机制新颖、定价被迫趋同"的生物药。对 tulisokibart 而言，差异化不仅是临床命题，更是定价与准入的生死命题。07 · 未来 1 把基因数据合规当成一号工程。在中国队列推进的同时，前置设计遗传检测的本地化方案与人类遗传资源审批路径，避免样本与基因数据出境成为里程碑的隐性杀手。 2 以全人群标签抢首发，不被伴随诊断拖累节奏。先拿全人群获批占住"中国首个抗 TL1A"，把生物标志物留作上市后增值，而非注册前置条件。 3 尽早锁定加速通道并谈拢中国安全暴露量底线。以全球首创机制 + 中国未满足需求为支点申请突破性治疗与优先审评，并就中国亚组安全数据库的可接受体量与监管达成共识。 4 抢占头部中心的入组优先级。在与多个同类三期争夺同一患者池的现实下，借助默沙东与国家级消化中心的关系，确保入组速度不被竞品挤压。 5 提前搭建消化专科商业与准入能力。补齐 IBD 医学事务、专科市场与医保双通道证据包，把默沙东在肿瘤/疫苗上的组织优势复制到一条新的专科战线。结语：先发优势是真的，但赢面要靠执行兑现 tulisokibart 拿下了 TL1A 这一全新机制的全球第一个三期阳性，机制差异化真实、疗效信号连贯、开发商资源充足、中国已在全球研究之内——这些都是结构性的正向条件。但它在中国的真正胜负手，不在分子本身，而在三道关卡：伴随诊断能否落地、基因数据合规能否提速、医保准入能否在价格战中守住价值。这是一个"机制赢在起点、执行决定终点"的资产。中国市场不缺一个迟到的全球新药，缺的是一个把全球胜利快速、合规、有价值地兑现到中国患者身上的执行样本。免责声明：本文基于公开信息与公开研究整理分析，所涉临床数据、监管节点、竞争格局等截至 2026 年 6 月，可能随后续披露而变化。文中观点为基于现有证据的分析判断，不构成任何投资、医疗或商业决策建议；涉及未上市产品的疗效与安全性表述均以申办方与监管机构正式信息为准。所有商品名、企业名归各自权利人所有。

临床3期临床2期引进/卖出临床终止临床1期

2026-06-28

·GoAiLife

辉瑞-Seagen败局背后的并购真相：MNC如何在“超级并购大年”中避免价值毁灭？

2026上半年，制药业并购狂飙1300亿美元，艾伯维、礼来精准补强，GSK百亿“补课”。然而辉瑞430亿鲸吞Seagen却成梦魇——核心ADC管线三度折戟，巨额减值触目惊心。并购并非终点，整合才是关键。当专利悬崖催生“用钱买时间”的集体焦虑，最大的教训莫过于：别为宏大叙事支付过高溢价，别让并购掩盖战略短板。潮退之时，唯有价值创造者留在岸上。 2026年注定被载入全球制药工业史册——截至上半年，全球生物医药领域10亿美元以上的收购至少已有34起，总金额突破1300亿美元，已超过2025年全年水平。然而，在这波“超级并购大年”的狂欢中，辉瑞430亿美元收购Seagen的败局如同一记警钟：当sigvotatug vedotin在III期临床失败，当继Felmetatug vedotin之后第三个Seagen项目折戟，这场看似“投资430亿美元抗击癌症”的豪赌，正演变为一场价值毁灭的教科书级案例。本文将系统梳理MNC并购的成与败，并以辉瑞-Seagen为镜鉴，为正在考虑并购的药企提供深度启示。一、并购的“得”：MNC如何通过并购实现战略跃迁 1.1 艾伯维收购Apogee：免疫王座的“补强型”标杆 2026年6月22日，艾伯维宣布以约109亿美元全现金收购免疫领域生物科技公司Apogee Therapeutics。这笔交易的核心资产是zumilokibart，一款针对多种炎症性疾病的实验性疗法。艾伯维的并购逻辑值得深思：这并非“以规模换增长”的粗放扩张，而是“在核心优势领域筑高护城河”的精准补强。艾伯维旗下瑞福（Rinvoq）和瑞莎珠单抗（Skyrizi）今年销售额预计突破310亿美元，已成功填补了修美乐专利到期后的收入缺口。但强生等对手推出的口服竞品正持续压制其股价，因此艾伯维需要更强的免疫管线来巩固王座。分析师认为，这笔交易的典型特征在于：不是为了规模，而是为了在核心优势领域筑高护城河。艾伯维首席执行官Robert Michael明确表示，Apogee的研发管线具备成长为“超级重磅药物”（年销售额超过100亿美元）的潜力。 1.2 礼来的“双轨并购”策略：广撒网与精捕捞并行礼来是2026年并购市场的绝对主角——截至6月16日，礼来今年已官宣11笔并购交易，共花费至少253亿美元，占整个行业的一半。礼来业务拓展负责人杰克·范·纳尔登透露了其并购的双轨策略：模式一：广撒网，批量布局临床早期项目。核心逻辑在于“大部分早期管线最终都难以研发成功，但整体投入可控。只要其中一两个项目顺利落地，收益就能覆盖全部前期投入。” 模式二：聚焦已获得概念验证数据的候选药物，即“交易达成时疗效已得到实锤验证”的品种。这两种模式并行推进，使礼来既能以78亿美元收购Centessa Pharmaceuticals拿下睡眠神经科学资产，也能以未公开金额收购4E Therapeutics布局非阿片镇痛赛道——后者虽然处于早期阶段，但靶点新颖（MNK-eIF4E信号通路），且能规避成瘾、认知损伤等中枢神经系统副作用，差异化优势明确。 1.3 GSK的“补课式”收购：为十年前的战略失误买单 2026年6月9日，GSK宣布以约106亿美元收购Nuvalent，创下其史上非合并类对外收购的最高金额。核心管线包括ALK抑制剂neladalkib和ROS1抑制剂zidesamtinib，前者已获FDA突破性疗法认定并于2026年4月申报上市。这笔收购背后有一个深刻的战略教训。2015年，时任CEO安德鲁·维蒂主导了与诺华的资产置换交易，将GSK的肿瘤业务整体打包卖出，转而聚焦疫苗、消费保健品和呼吸系统药物。随后肿瘤免疫疗法的爆发，使这一决策被普遍视为GSK历史上最大的战略失误。 GSK新任CEO卢克·米尔斯上任后，已将业务发展和并购列为优先事项，以应对专利到期的结构性压力。这笔百亿美元收购被视为“一步一个脚印重建肿瘤管线”战略中最重要的一块砖。 GSK的密集并购节奏还包括：2025年1月以约10亿美元收购IDRx，2025年7月与恒瑞医药达成重磅合作，2026年1月以22亿美元收购RAPT Therapeutics。这些交易共同构成了GSK在肿瘤、免疫炎症、呼吸等多个领域的“补课式”布局。 1.4 强生收购Intra-Cellular：中枢神经赛道的战略卡位 2025年1月，强生以约146亿美元收购专注于中枢神经系统疾病疗法的Intra-Cellular Therapies公司。通过此次收购，强生获得了已获批用于治疗成人精神分裂症及双相情感障碍的Caplyta（lumateperone），以及处于2期临床阶段的候选药物ITI-1284，后者正在评估用于治疗广泛性焦虑障碍和阿尔茨海默病相关的精神病及抑郁症。这同样是一笔典型的“补强型”收购——强生在神经科学领域已有一定布局，通过收购获得已上市产品和后期管线，大幅缩短了研发周期，降低了早期研发的不确定性。二、并购的“失”：辉瑞Seagen如何沦为价值毁灭范本 2.1 估值泡沫：430亿美元买到的“希望”正快速缩水 2023年，辉瑞以430亿美元收购Seagen。这场交易从一开始就饱受质疑：Seagen 2022年全年产品净销售额仅17亿美元，以当时市场估值逻辑计算，超过市场预期的溢价水平意味着辉瑞必须寄望于Seagen管线中的重磅炸弹级药物才能实现合理回报。辉瑞在新闻稿中高调宣称“投资430亿美元抗击癌症”，试图为并购赋予宏大叙事。然而，sigvotatug vedotin在III期临床试验中失败——这款针对转移性非鳞状非小细胞肺癌的ADC药物，曾是Seagen管线中最受瞩目的核心资产。这已是继B7-H4 ADC药物Felmetatug vedotin等项目折戟后，第三个源自Seagen的失败管线。辉瑞曾对这些项目寄予厚望，将其视为2030年前打造至少8款潜在重磅药物的关键支柱。每个失败的管线都在侵蚀着这430亿美元的价值基础。 2.2 整合之痛：MNC并购的系统性风险辉瑞的Seagen案例并非孤例。从MNC并购史的普遍规律来看，大型并购成功概率并不高。主要原因包括：文化冲突：大型药企与小型生物技术公司之间存在显著的文化差异。前者倾向于成本控制和流程化管理，后者崇尚创新、快速迭代和扁平化结构。当一家以创新为导向的生物科技公司被大型药企收购后，可能因文化差异而导致创新能力下降、核心人才流失。管线估值与现实的落差：MNC在收购时往往对早期管线的潜力过于乐观，忽视了从早期到三期临床试验的“死亡之谷”风险。sigvotatug vedotin从早期数据亮眼直接推进III期，最终失败，正是这一风险的典型案例。巨额债务的隐形压力：为完成430亿美元收购，辉瑞承担了大量债务，这进一步限制了其在其他领域的投入灵活性。有分析指出，“辉瑞处境相当不妙，该公司已经承担了很多债务”。 2.3 并购后整合失败的典型案例：GSK的“高价接盘”警示 GSK虽然近期通过一系列并购积极补课，但其过往的并购教训同样值得关注。 GSK曾以10亿美元首付款及4亿美元监管里程碑款收购Aiolos Bio，而Aiolos仅以2500万美元首付款从恒瑞医药引进核心管线后便溢价转售。在RAPT Therapeutics收购案中，GSK支付了每股58美元、总股权价值22亿美元的价格，而RAPT此前从济煜医药引进同一药物时首付款仅为3500万美元，GSK的收购价格较RAPT当时9.73亿美元的市值溢价126%。这种“高价接盘”模式引发市场质疑：GSK为何频繁充当“溢价买家”？分析指出，这既反映了全球优质生物科技资产竞争的激烈程度，也折射出大药企在“专利悬崖”压力下对管线“补货”的刚性需求——当时间紧迫，价格就变成了次要因素。三、并购浪潮的底层逻辑：专利悬崖下的集体求生 MNC之所以如此密集地发起并购，核心驱动力在于即将到来的专利悬崖海啸。据行业数据，到2027-2028年，全球年销售额约1800亿美元、占比近12%的产品将面临专利到期风险。2025至2030年间，年销售额合计超过2000亿美元的药品将因专利到期和生物类似物竞争失去独占权。具体来看： ——默沙东的帕博利珠单抗（Keytruda）将于2028年失去美国专利保护，这款药2025年卖出316.80亿美元，占默沙东制药收入的半壁江山 ——诺和诺德的司美格鲁肽（semaglutide）核心化合物专利于2026年3月在中国到期，全球仿制药伺机而动 GSK的核心艾滋病药物多替拉韦钠未来几年专利到期，直接导致其面临收入增长压力 ——诺华的心血管王牌产品Entresto在2025年专利失效后面临仿制药竞争到2032年，价值约2000亿至3500亿美元的知名药品将失去专利保护。正如医药分析师所言：“大型制药公司没有等待八、九、十年去建立内部管线的奢侈，它们不再是为了选择性而购买，而是在购买时间。” 这种“用资金换时间”的逻辑，推动了2026年上半年的1300亿美元并购狂潮。四、给正在考虑并购的企业的启示启示一：认清并购的决定性变量——整合能力而非交易规模当前MNC的并购逻辑已从“追求规模扩张”转向“精细化卡位”。艾伯维109亿美元收购Apogee之所以被看好，是因为它在免疫领域的整合能力已经经过修美乐→瑞福/Skyrizi的成功经验验证。礼来之所以敢在半年内砸253亿美元，是因为有代谢领域丰厚营收作为后盾，且建立了成熟的BD整合机制。核心判断：如果缺乏明确的整合策略和成功经验，大规模并购可能带来的是双重风险叠加。启示二：警惕“为并购而并购”的战略迷失辉瑞-Seagen案例的最深刻教训在于：不要为美好的故事支付过高的价格。430亿美元的“抗击癌症”叙事很动人，但忽略了几个关键问题：这些管线资产的失败概率有多高？当三期临床失败后，是否有备选方案？溢价是否过度透支了未来的投资灵活性？对比来看，GSK收购Nuvalent之所以被称为“合理的补课”，是因为它有明确的战略逻辑：弥补2015年战略失误造成的肿瘤管线空白。虽然也是百亿级交易，但背后的逻辑是清晰的——而非简单地“买买买以应对专利悬崖”。启示三：关注并购的“节奏”与“容量” 礼来的双轨策略提供了有价值的参考：广撒网与精捕捞并行，控制单笔交易的风险敞口。礼来不仅做大规模并购（如78亿美元收购Centessa），也频繁进行较小规模的早期布局交易（如收购4E Therapeutics）。这种“大小并举”的模式，既能搏到“超级重磅药物”的潜在上限，又不会因单一交易失败而伤筋动骨。相比之下，辉瑞430亿美元“All-in”Seagen的战略无异于一场豪赌——把所有鸡蛋放在一个篮子里，一旦篮子摇晃，后果就是连锁性的价值毁灭。启示四：建立科学的“管线评估”机制许多MNC在收购小公司时，会夸大收购管线的临床价值。以GSK收购Aiolos Bio为例，Aiolos仅以2500万美元从恒瑞引进管线，转手就以14亿美元卖给GSK，溢价56倍。这反映出一个深层问题：大药企在专利悬崖压力下，往往愿意为“希望”支付不合理的高价。合理的做法是：根据临床阶段设定不同的估值标准——早期管线按照成功率折现，后期管线按照已验证数据评估，已上市产品按照现金流模型估值。避免用“All-or-Nothing”的二元思维来评估一个高度不确定的管线组合。启示五：保持对“资产减值”风险的敬畏当sigvotatug vedotin失败后，辉瑞面临的不只是管线损失，还有资产负债表的压力——此前仅Felmetatug vedotin的终止就计提了10亿美元的无形资产减值。三期临床失败意味着数十亿甚至上百亿美元的投资可能“打水漂”。这一点对所有MNC同样适用：当收购金额占公司市值或现金储备的比例过高时，需要建立明确的风控机制——比如设定“一旦临床失败，立即止损”的决策节点，避免因“沉没成本误区”而继续投入。结语：并购不是终点，整合才是 2026年上半年的1300亿美元并购狂潮仍在持续——艾伯维买免疫、GSK买肿瘤、礼来买神经科学、强生买中枢神经……每家MNC都在用真金白银回答同一个问题：当今天的现金牛失去专利保护时，明天的增长引擎在哪里？然而，辉瑞-Seagen案例提醒我们：并购本身不创造价值，只有成功的整合才能将收购资产转化为股东回报。在并购的得与失之间，平衡之道在于：既有敢于出手的魄力，更有懂得取舍的智慧；既有抢占赛道的速度，更有精准评估的冷静。对于正在考虑并购的企业而言，或许最值得铭记的教训是：不要为美好的故事支付过高的价格，不要忽视管线失败的真实概率，更不要让并购成为掩盖自身战略缺陷的工具。当“超级并购大年”的浪潮退去，能够留在岸上的，是那些真正懂得如何通过并购创造价值——而非只是转移价值的公司。 Copyright©2026. All Rights Reserved. 免责声明：本文章内容基于公开信息整理，由AI辅助生成，旨在分享知识，仅供参考，不构成任何专业建议或承诺，不代表本公众号立场。用户须自行甄别所获信息的真实程度及适用条件，并完全承担因使用该信息所引发的一切后果与责任。

2026-06-26

·PRNewswire

SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease

SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis Approval includes a new 55 mg pre-filled syringe to support weight-based dosing for those patients weighing less than 40 kg SKYRIZI becomes the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six years of age and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis NORTH CHICAGO, Ill., June 26, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. A new 55 mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg PFS and Pen are approved for patients weighing 40 kg or greater. "Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints – these conditions can shape daily life and disrupt important childhood experiences," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We are proud that SKYRIZI is now the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six years of age and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis. For families navigating these chronic conditions, expanding access to treatments with proven efficacy supports improved disease management and extends established standards of care to younger patients." Approximately 30% of people who develop psoriasis experience symptoms before age eighteen.1 Each year, approximately 20,000 children under ten years old are diagnosed with psoriasis in the U.S., and an estimated 14,000 children are impacted by psoriatic arthritis.1,2,3 Psoriasis and psoriatic arthritis symptoms in children can interfere with mobility and daily activities, with additional burden on caregivers.4,5 "For children impacted by immune-mediated diseases, childhood can become shaped by doctor appointments, uncertainty and the emotional weight of living with a chronic disease," said Leah M. Howard, J.D., president and chief executive officer, National Psoriasis Foundation. "Having an approved treatment for both skin and joint disease available for our younger patients gives families another much-needed option and offers a measure of hope as they navigate the challenges of these diseases." Data Supporting SKYRIZI Pediatric Approvals The pediatric psoriasis approval is supported by data from the Phase 3 OptIMMize psoriasis clinical trial program (NCT04435600; NCT04862286), including data from two lead-in pharmacokinetic cohorts, a randomized efficacy assessor-blinded active controlled cohort (12 to <18 years) and a single arm open label cohort (6 to <12 years). The pediatric psoriatic arthritis approval is supported by the OptIMMize psoriasis clinical trial program as well as population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies. The safety profile observed in pediatric plaque psoriasis patients treated with SKYRIZI was consistent with the established safety profile of SKYRIZI in adult patients with plaque psoriasis. "At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment," said Amy S. Paller, M.D., chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and study investigator in the OptIMMize program. "These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis." Patient Access and Support AbbVie is committed to helping people access SKYRIZI and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $0 per month for eligible, commercially insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides SKYRIZI at no charge to those who qualify. More information about this assistance program can be found at . About SKYRIZI ® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. SKYRIZI is approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. SKYRIZI ® (risankizumab-rzaa) U.S. Uses and Important Safety Information SKYRIZI is a prescription medicine used to treat: moderate to severe plaque psoriasis in adults and children 6 years of age and older who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis in adults and children 6 years of age and older. moderate to severe Crohn's disease in adults. moderate to severe ulcerative colitis in adults. IMPORTANT SAFETY INFORMATION What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)? SKYRIZI is a prescription medicine that may cause serious side effects, including: Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk. become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?" Liver problems may happen while being treated for Crohn's disease or ulcerative colitis: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment, and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine. The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. Use SKYRIZI exactly as your healthcare provider tells you to use it. SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 55 mg/0.37 mL prefilled syringe, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. This is the most important information to know about SKYRIZI. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide. About AbbVie in Immunology AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease. Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References Menter A et al. (2020). Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. Journal of the American Academy of Dermatology, 82(1), 161–201. Brunello, Francesco et al. (2022). New Insights on Juvenile Psoriatic Arthritis. Frontiers in Pediatrics, 10, 884727. Morgan, E. M., et al. (2019). Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop. The Journal of Rheumatology, 46(8), 1006–1013. Salman, A., et al. (2018). Impact of psoriasis in the quality of life of children, adolescents and their families: a cross-sectional study. Anais Brasileiros de Dermatologia, 93(6), 819–823. National Psoriasis Foundation. For Parents: Emotional Impact. Available at: . Accessed June 2026. SOURCE AbbVie 21% more press release views with Request a Demo

100 项与利生奇珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	利生奇珠单抗	L04AC18	DB14762

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
活动性中度克罗恩病	中国	AbbVie, Inc.	2025-03-04
活动性重度克罗恩病	中国	AbbVie, Inc.	2025-03-04
溃疡性结肠炎	日本	AbbVie, Inc.	2022-09-26
克罗恩病	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性中度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性重度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
斑块状银屑病	加拿大	AbbVie, Inc.	2019-04-17
银屑病关节炎	日本	AbbVie, Inc.	2019-03-26
红皮病性银屑病	日本	AbbVie, Inc.	2019-03-26
寻常性银屑病	日本	AbbVie, Inc.	2019-03-26
脓疱型银屑病	日本	AbbVie, Inc.	2019-03-26
手掌和足底脓疱病	日本	AbbVie, Inc.	2019-03-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	临床3期	美国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	澳大利亚	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	加拿大	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	法国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	德国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	意大利	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	波兰	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	西班牙	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	英国	AbbVie, Inc.	2024-07-08
掌跖角化病	临床3期	美国	AbbVie, Inc.	2021-02-26

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06333860 (IMMpactful, Pubmed \| Dermatol Ther (Heidelb))	临床4期	斑块状银屑病	150	Risankizumab 150 mg	齋願簾繭鏇鹽醖夢夢選(遞簾顧遞積獵積顧壓艱) = 膚顧餘夢觸襯蓋製鑰願鏇積網製夢衊艱壓膚蓋 (鏇膚鹹蓋簾積遞遞廠蓋 ) 更多	积极	2026-05-17
				Deucravacitinib 6 mg	齋願簾繭鏇鹽醖夢夢選(遞簾顧遞積獵積顧壓艱) = 醖構選醖艱衊製繭窪糧鏇積網製夢衊艱壓膚蓋 (鏇膚鹹蓋簾積遞遞廠蓋 ) 更多
NCT06333860 (IMMpactful, AAD2026)	临床4期	斑块状银屑病	393	Risankizumab 150 mg	淵艱餘構餘淵蓋積壓夢(顧醖壓糧膚壓獵遞鹹夢) = 廠築衊夢夢襯願窪艱範選顧簾餘願艱糧製壓獵 (糧餘網鏇淵積淵廠遞淵 ) 更多	积极	2026-03-27
				Deucravacitinib 6 mg	淵艱餘構餘淵蓋積壓夢(顧醖壓糧膚壓獵遞鹹夢) = 鹹鹹憲鹹艱積顧簾壓鬱選顧簾餘願艱糧製壓獵 (糧餘網鏇淵積淵廠遞淵 ) 更多
AAD2026	N/A	银屑病 \| 银屑病关节炎	5,832	Risankizumab (PsO)	願憲構鏇齋觸蓋選構製(蓋蓋壓艱醖顧衊憲窪簾) = 餘醖鹽鹹鏇齋蓋製範淵夢鹽繭衊蓋糧蓋憲鏇膚 (範壓蓋製鬱獵膚鏇構範 ) 更多	积极	2026-03-27
				Risankizumab (PsA)	淵顧範簾顧淵夢網蓋簾(艱鏇衊衊簾簾網繭選窪) = 醖艱衊鹹鬱蓋鹹餘鬱構網積壓鹹遞襯鑰糧築廠 (觸淵襯鑰襯襯選襯窪艱 ) 更多
NCT06333860 (IMMpactful, AAD2026)	临床3期	斑块状银屑病	393	Risankizumab	衊憲獵壓糧繭襯蓋築鹹(願網餘選襯構製獵遞鏇) = 鏇餘願築齋壓蓋鑰鏇艱鬱顧簾鑰鹹襯窪積積糧 (構選網齋餘壓願壓鹽簾 ) 更多	积极	2026-03-27
				Deucravacitinib	衊憲獵壓糧繭襯蓋築鹹(願網餘選襯構製獵遞鏇) = 築構壓鏇衊繭鬱襯窪構鬱顧簾鑰鹹襯窪積積糧 (構選網齋餘壓願壓鹽簾 ) 更多
NCT05969223 (UnIMMited, AAD2026)	临床4期	银屑病 \| 头皮银屑病	165	Risankizumab 150 mg (Genital Psoriasis)	壓網鑰顧選築範積糧繭(艱簾積範範鹹窪觸衊艱) = 淵製蓋積簾繭遞獵積範鹽餘築積觸製蓋願衊簾 (壓鬱鬱淵齋鏇願積蓋窪 ) 更多	积极	2026-03-27
				Placebo (Genital Psoriasis)	壓網鑰顧選築範積糧繭(艱簾積範範鹹窪觸衊艱) = 醖鑰觸膚願壓蓋廠廠鬱鹽餘築積觸製蓋願衊簾 (壓鬱鬱淵齋鏇願積蓋窪 ) 更多
NCT06063967 (AFFIRM, Company_Website) 人工标引	临床3期	克罗恩病	289	Risankizumab	餘鑰淵鬱膚鏇製願膚築(襯淵顧齋糧製餘淵簾憲) = 鑰齋獵選製窪餘獵願鑰鏇遞製構壓選網網衊糧 (範獵鹽壓襯繭觸夢獵觸 ) 更多	积极	2026-03-02
				Placebo	餘鑰淵鬱膚鏇製願膚築(襯淵顧齋糧製餘淵簾憲) = 遞淵願醖鹹製網範鹹膚鏇遞製構壓選網網衊糧 (範獵鹽壓襯繭觸夢獵觸 ) 更多
NCT05969223 (UnlIMMited \| UnIMMited, CTgov)	临床4期	斑块状银屑病 \| 银屑病 \| 银屑病关节炎 ... 更多	214	Placebo for Risankizumab (Study-G Placebo (Period A))	積壓窪艱積窪簾淵鏇顧 = 遞願鏇鹹醖選餘獵獵鬱廠窪膚膚積膚製顧艱窪 (鹽鑰觸淵襯鏇遞夢蓋憲, 夢夢鑰觸鏇淵願築願選 ~ 觸築顧遞網淵蓋糧艱糧) 更多	-	2026-02-24
				Risankizumab (Study-G Risankizumab (Period A))	積壓窪艱積窪簾淵鏇顧 = 齋艱壓膚艱壓簾構齋鬱廠窪膚膚積膚製顧艱窪 (鹽鑰觸淵襯鏇遞夢蓋憲, 築壓艱窪憲憲窪糧齋鬱 ~ 築積範鹹遞顧鑰廠鹹蓋) 更多
ECCO2026	N/A	克罗恩病引起的肛周瘘	323	Risankizumab	製鏇夢構觸簾鑰構遞顧(醖觸餘製憲獵襯齋窪窪): HR = 2.83 (95.0% CI, 1.5 ~ 6.34)	积极	2026-02-18
				Upadacitinib
RESOLVE IG-IBD (ECCO2026)	N/A	克罗恩病引起的肛周瘘	520	Risankizumabustekinumab (UST) (prior ustekinumab (UST) exposure)	淵積艱築積製遞構獵鏇(醖鹽蓋餘獵淵網齋願淵) = 築衊網齋餘網築憲夢蓋鏇襯觸築鏇廠衊網積衊 (遞網積顧觸憲醖壓蓋憲 ) 更多	积极	2026-02-18
				Risankizumab (failed ≥3 biologics)	淵積艱築積製遞構獵鏇(醖鹽蓋餘獵淵網齋願淵) = 廠簾淵積選獵壓壓獵餘鏇襯觸築鏇廠衊網積衊 (遞網積顧觸憲醖壓蓋憲 ) 更多
COMMAND Open-Label Extension (ECCO2026)	临床3期	活动性重度溃疡性结肠炎	2,006	Risankizumab 180 mg	鬱構觸觸醖艱網衊遞顧(顧鹹積獵構獵鏇壓鏇齋) = 憲窪蓋窪觸鏇壓網顧鑰襯觸製築夢鑰選淵衊艱 (簾夢廠夢構鏇齋淵簾淵 )	积极	2026-02-18
				Risankizumab 360 mg	鬱構觸觸醖艱網衊遞顧(顧鹹積獵構獵鏇壓鏇齋) = 餘簾蓋積憲築醖糧遞窪襯觸製築夢鑰選淵衊艱 (簾夢廠夢構鏇齋淵簾淵 )