Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

开始日期2025-06-26

申办/合作机构

AbbVie, Inc.

NCT07007091

/ Recruiting临床1期

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

开始日期2025-06-12

申办/合作机构

AbbVie, Inc.

NCT06946524

/ Recruiting临床1期

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to Prefilled Syringe

This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.

开始日期2025-05-08

申办/合作机构

AbbVie, Inc.

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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625

项与利生奇珠单抗相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Interleukin-23p19 inhibitors for the treatment of moderate-to-severe psoriasis: an expert opinion of real-world evidence studies in Europe

Review

作者: Thaçi, D. ; Ständer, S.

Background: Psoriasis is a chronic inflammatory disease affecting about 2% of the global population, with moderate-to-severe forms requiring systemic treatment for successful disease management. By targeting the interleukin (IL)-23p19 subunit of IL-23, the master cytokine of psoriasis pathogenesis, guselkumab, tildrakizumab, and risankizumab offer improved risk-benefit profiles.Objective: While randomized clinical trials (RCTs) provide controlled data, real-world evidence (RWE) offers insights into the performance of these therapies in diverse patient populations, including those with comorbidities or difficult-to-treat areas affected. With RWE on these inhibitors constantly emerging, a comprehensive overview and expert interpretation are essential for providing key insights into psoriasis management in clinical practice.Methods: This review, therefore, examined RWE on the effectiveness and safety of IL-23p19 inhibitors compared to their pivotal RCTs.Results: Despite some gaps between RCT and RWE outcomes, particularly in underrepresented subpopulations, IL-23p19 inhibitors show strong effectiveness and favorable safety across both settings in the short- and especially in the long term, accompanied by an improvement in health-related quality of life and reduction of the main symptoms.Conclusion: Altogether, these factors make these medicines ideal treatment options. Future research should focus on improving patient-reported outcomes, specifically addressing psychological and quality-of-life aspects, to further optimize psoriasis management.

2025-06-09·CLINICAL AND EXPERIMENTAL DERMATOLOGY

Treatment of refractory pityriasis rubra pilaris with biologic therapy: a case series.

Article

作者: Han, Richard ; Spratt, William R ; Lee, Senhong ; Lai, Francis Y X ; Yang, Howard

Pityriasis rubra pilaris (PRP) is a rare inflammatory dermatosis with limited data on biologic therapies. We present a case series to evaluate the efficacy, time to primary response (TTPR), and tolerability of biologics in PRP management. A retrospective analysis of 11 PRP patients treated with biologics at a tertiary Australian dermatology department was conducted. Patient demographics, prior therapies, and treatment outcomes were reviewed. Biologics demonstrated variable efficacy: significant responses were seen with secukinumab (n=3/4, 75%), tildrakizumab (n=2/7, 28.6%), ixekizumab (n=1/2, 50%), and risankizumab (n=1/1, 100%). Adalimumab yielded partial response for two patients (n=2/3, 66.7%). Combination therapy with systemic agents appeared to improve outcomes. Tildrakizumab had the shortest mean TTPR (6.76 weeks). Adverse effects were rare but led to treatment discontinuation in three patients. Sequential biologic therapy demonstrated some benefit to non-responders. These findings highlight the need for standardised treatment outcome measures and further research in PRP treatment.

2025-06-09·Lancet Gastroenterology & Hepatology

Development and validation of a novel Endoscopic ulcer Activity Score for Evaluation of Crohn's Disease (EASE-CD) using data from two randomised controlled trials.

Article

作者: Mosli, Mahmoud ; Shackelton, Lisa M ; Peyrin-Biroulet, Laurent ; Maguire, Bryan R ; Rubin, David T ; Danese, Silvio ; Panaccione, Remo ; Sands, Bruce E ; Ma, Christopher ; Leong, Rupert W ; Khanna, Reena ; Rémillard, Julie ; Sparrow, Miles P ; Hindryckx, Pieter ; Jairath, Vipul ; Bressler, Brian ; Feagan, Brian G ; Hart, Ailsa L ; Zou, Guangyong ; D'Haens, Geert R

BACKGROUND:

Endoscopy is essential for measuring luminal disease activity in Crohn's disease. Existing indices for evaluating endoscopic Crohn's disease activity are only modestly correlated with clinical disease activity, contain items with ambiguous definitions and poor interobserver reliability, and do not have validated thresholds for defining clinically relevant changes. To address these issues, we conducted a multiphase study to develop and validate a novel endoscopic index for Crohn's disease.

METHODS:

Paired baseline and post-induction ileocolonoscopy videos from a phase 3b adalimumab trial (NCT00348283) and phase 2 risankizumab trial (NCT02031276) were assessed by multiple central readers using candidate endoscopic items with face validity derived using modified RAND/UCLA appropriateness methods. The four readers were masked to all clinical information, including treatment assignment and patient symptom scores. A total of 112 and 99 paired ileocolonoscopy videos with treatment assignment were available from the adalimumab trial and risankizumab trial, respectively; after the four readers assessed the 112 videos, two readers then reassessed 44 post-treatment videos to assess inter-rater reliability in index development. Items with acceptable inter-rater reliability (with an intraclass correlation coefficient [ICC] of ≥0·41) and responsiveness (win probability [WinP], the probability that a patient receiving active treatment has a better endoscopy score than a patient receiving placebo, of ≥0·56) were included as covariables in regression for model building with internal validation with bootstrapping. External validation was conducted using the paired videos from the risankizumab trial.

FINDINGS:

Ten endoscopic items met ICC and WinP thresholds and were considered for novel index development. They included items from the SES-CD (presence and size of ulcers, extent of ulcerated surface, and extent of affected surface) and CDEIS (percentage of surface involved by Crohn's disease, percentage of ulcerated surface, deep ulceration, and superficial ulceration) and exploratory items (presence of Crohn's disease-related lesions, Crohn's disease-related lesion severity, and Crohn's disease-related lesion involvement). The final model, Endoscopic ulcer Activity Score for Evaluating CD (EASE-CD), included the presence and size of ulcerations measured on an ordinal scale of 0 (none), 1 (ulcers <5 mm), 2 (ulcers between 5 mm and 20 mm), and 3 (ulcers >20 mm); the presence or absence of deep ulcerations measured dichotomously, with 0 for absent and 1 for present; and the proportion of ulcerated surface area, expressed as a continuous proportion from 0-1, with each item evaluated and averaged across visualised bowel segments. The total score ranges from 0-100 with higher scores indicating greater endoscopic activity. The r² and optimism adjusted r² of EASE-CD in internal validation were 0·608 and 0·554, and the index was well calibrated with a slope of 0·983. In external validation, the adjusted r² was 0·565 and the calibration slope was 0·997. EASE-CD also demonstrated substantial inter-rater reliability (ICC 0·798 [95% CI 0·711-0·836]) and a large degree of responsiveness (WinP 0·769 [95% CI 0·658-0·851], p<0·001) in external validation. A 10-point reduction in EASE-CD had 82·4% specificity (95% CI 78·6-86·0) and 69·9% sensitivity (63·3-76·4) for endoscopic response, defined by at least 50% reduction in SES-CD or CDEIS. Ulcer-free endoscopic remission results in EASE-CD score of 0.

INTERPRETATION:

EASE-CD is a novel, internally and externally validated continuous measure of endoscopic ulcer activity in Crohn's disease that is reliable and responsive to treatment.

FUNDING:

None.

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项与利生奇珠单抗相关的新闻（医药）

2025-06-17

·美柏医健

中药蹭创新药热度

谁在中药里躲牛市？今年以来，中证中药指数下跌1.2%，而中证港股通创新药指数上涨71.6%。世界的悲喜并不同频，2023年，当创新药凄风冷雨之际，中药却感觉人生已经到达高潮，超六成中药上市公司业绩正增长，然而，高光时刻过于短暂，中药板块（75家中药上市公司）2024年营收同比-4.6%，净利润同比-18.7%，2025Q1颓势持续，营收同比-8.3%，净利润同比-5.7%。时代潮流浩浩荡荡，创新为王。中国创新药2024年对外授权交易金额达571亿美元，2025年初至今对外交易总金额已突破500亿美元，10项中国管线跻身2025年全球交易金额TOP20。中国创新药在细胞疗法、ADC、双抗领域在研管线数量全球第一，在716个赛道研发进度第一，有望继续依托License-out模式兑现创新价值。言必称BD，连中药企业也不例外。当片仔癀抱紧明朝宫廷秘方时，云南白药开始拥抱核药；当传统中药企业还在为集采扩面发愁时，京新药业自从开发精神类创新药，整个人都精神多了，众生药业在高景气赛道几乎全布局，走得太快，完全洗去中药的色彩。当前几年创新药卑微到尘埃里时，少数中药企业放着好日子不过，依靠丰厚的现金流，布局高风险项目，因为他们相信：创新是医药行业的大势所趋。 01 中药加入吧，外面都是创新药的人了不是玩笑，外面真的都是创新药的人了。跨国药企面临专利悬崖，未来10年需要外购管线填补超2400亿美元市场空缺，而中国创新药凭借物美价廉优势，成为FIC/BIC潜力管线批量化供给的核心力量。2024 年重磅药物销售情况和专利信息（百万美元）27款2024年全球销售超过40亿美元的药品在美国将面临专利悬崖，以2024年销售额为准，合计潜在损失金额约2443亿美元。其中，涉及100亿美元级别药物共计9款，包括默沙东的K药、诺和诺德的司美格鲁肽、赛诺菲的度普利尤单抗、辉瑞的阿哌沙班、艾伯维的利生奇珠单抗、吉利德的Biktarvy、强生的达雷妥尤单抗、礼来的替尔泊肽以及Vertex的Trikafta。BMS：在来那度胺从2021年128亿美元全球峰值降低至2024年约58亿销售之后，目前主要面临的危机是阿哌沙班与O药两大“现金牛”的滑铁卢，两款产品均将在2027 年专利到期，2024年合计销售额达226亿美元。默沙东：未来五年，K药、西格列汀/二甲双胍、来特莫韦均将面临专利悬崖，仅K药2024年全球销售接近300亿美元，美国专利将在2029年到期。辉瑞：肿瘤药物lbrance、Xtandi以及关节炎药Xeljanz都将于2027年前专利到期。强生：肿瘤药物Darzalex、Erleada，肺动脉高压药物Opsumit、Uptravi，新血管药物Xarelto以及HIV药物Edurant将于2030年前专利到期。礼来：糖尿病药物Trulicity、Jardiance，关节炎药物Taltz以及肿瘤药物Cyramza将于2030年专利到期。TOP 10 MNC 的总市值和现金情况MNC均有迫切寻找重磅创新药的需求，而且全是膀大腰粗的金主，年度研发费用大部分超100亿美元，现金储备+可借债务基本上超100亿美元。MNC饿了来馒头，中国在各个创新领域在研管线数量不是全球第一就是全球第二，以青苗价无限供应FIC/BIC标的。细胞疗法、ADC、双抗、三抗/多抗、溶瘤病毒，中国在研管线数量超过美国，排名全球第一。PROTAC、基因疗法、小核酸药物、mRNA疫苗，中国也在追赶美国，差距较小。也许很快，中国在所有领域管线数量都达到全球第一。华福证券、医药魔方根据靶点和药品类型对创新药进行归类，将具有相同靶点和药品类型的创新药视为同一个赛道。全球在研创新药共覆盖3212个赛道，中国企业在研产品覆盖1300个赛道，覆盖度40%。中国产品在716个赛道（22%）的研发进度排名第一。相比之下，美国企业的在研产品覆盖1689个赛道，覆盖度53%，在其中1212个（38%）赛道研发进度排名第一。截至6月7日，2025年全球医药领域已完成443条交易，中国完成对外交易73条。2025年初至今，中国创新药对外交易总金额已超过500亿美金，占全球交易总金额的44%，首付款约25亿美金，占全球首付款的23%。首付款占比远低于总金额占比，原因在于，一是中国BD项目以早研管线为主，相对便宜，但研发进度位居全球前列，有机会成为MNC接替重磅品种专利悬崖的种子选手，二是中国创新药企经历凛冽寒冬后，心有余悸，惊魂未定，并没有耐心待价而沽，宁愿早卖贱卖。今年初至今的全球交易总金额 TOP20 项目今年初至今的全球交易总金额TOP20项目，来自中国的创新药管线有10项，占比50%，包括BioNTech的PM8002（来自普米斯）、三生制药/三生国健的SSGJ-707、和铂医药的早期管线，合作伙伴主要是MNC，包括BMS、AZ、辉瑞和默沙东。今年至今的全球交易首付款金额TOP20项目，来自中国的创新药管线有5项，占比25%。BioNTech的PM8002（来自普米斯）、三生制药SSGJ-707首付款均超过10亿美元。BD金额主要看首付款，首付款超1亿美元为大额BD，首付款超10亿美元为超级BD。中国创新药能从海外分成多少钱？2020年至今国内转国外授权交易总金额达1953亿美元。经华福证券测算，预计2020-2025年中国授权项目整体有望带来约82亿美元净利润，按10倍PE测算潜在市值增量达817亿美元。创新药牛市行至今日，有两个问题需要注意：你跑赢指数了吗？你能避开个股风险吗？相对完美的解决方案是配置ETF，港股创新药50ETF（513780）及其联接基金A/C（023597/023598）跟踪中证港股通创新药指数，近6个月区间涨幅达到52.5%。截至6月初，中证港股通创新药指数市盈率约28倍，处于近5年历史分位数的4%，位置仍然不高，而且公募基金对医药板块仍处于低配状态，增量资金入场空间巨大。港股创新药50ETF（513780）前十大成分股为头部企业：信达生物、百济神州、药明生物、石药集团、康方生物、中国生物制药、三生制药、再鼎医药、药明康德（数据来源：Wind，截止日期：2025年6月11日）。创新药短期上涨较大且较快，呈现一定程度的交易拥挤，在市场调整时，也可能出现快速修正，但中长期来看，调整是布局港股创新药50ETF（513780）的窗口。2025年成为中国创新药海外大单品爆发的元年，大量预期峰值过30-50亿美元的品种浮出水面，重磅交易持续不断，头部企业将长期受益于BD红利。 02 下一波转型浪潮由中药企业掀起MNC补充管线是一个长周期过程，后发创新的中药企业仍来得及搭便车。上一波转型浪潮是由仿创药企发动，几乎所有Pharma都已成功上岸，包括恒瑞医药、翰森制药、石药集团、中国生物制药、三生制药、华东医药、科伦药业、先声药业，下一波转型浪潮有望由中药企业掀起，唯有创新方可避免类似疫苗行业的螺旋式向下命运，代表企业有众生药业（GLP-1、流感）、康缘药业（GLP-1）、京新药业（精神神经药物）、悦康药业（小核酸）、以岭药业（疼痛、脑卒中）、云南白药（核药）、天士力（双抗、ADC、干细胞）、济川药业（流感、PDE4）、佐力药业（AAV基因治疗）、珍宝岛（ADC）、华纳药厂（抗抑郁）、九芝堂（干细胞）、羚锐制药（过敏性鼻炎）、桂林三金（CSF-1R单抗）。中药企业部分创新管线梳理资料来源：Wind、中信建投康缘药业：最舍得研发的中药企业，2024年研发费用率16.37%。以2.7亿元收购中新医药100%股权，布局神经系统及代谢疾病，核心管线包括ZX1305 （视神经损伤，重组人神经生长因子，IIa期）、ZX1305E（神经营养性角膜炎，重组人神经生长因子，I期），当前最引人注目的是GLP-1/GIP/GCG三靶点药物ZX2021，减重适应症处于临床II期，国内进展第二，仅次于联邦制药，I期数据已读出，安全性/减重数据可对标礼来Retatrutide。小分子化药氟诺哌齐阿尔兹海默适应症，处于II期临床，年内推进III期。京新药业：披着仿创外衣的中药企业，2021年中西药收入占比约为8:2，拥有200多个中药批文库，随着失眠药大单品地达西尼2023年11月国内独家上市，完成华丽转身。治疗精神分裂症的1类创新药JX11502MA胶囊II期临床接近尾声。以岭药业：虽然争议满身，但进取心一直很饱满，2024年研发费用率12.69%，加大一类创新药研发力度，用于术后疼痛新药苯胺洛芬注射液已申报上市，治疗AML的FLT3抑制剂XY0206的III期临床进行中。云南白药：加速推进核药管线，用于前列腺癌PET成像的INR101已在2025年5月开始III期入组，用于前列腺癌治疗的INR102处在I/IIa期。天士力：屡败屡战，创新永不言弃，2024年研发费用率9.77%，PD-L1/VEGF双抗B1962进入II期临床，FGF21靶点NASH药物Ia期试验完成统计报告，靶向CD44、CD133的自体CAR-T获批IND，罕见病腓骨肌萎缩症治疗药物PXT3003于2025年4月提交上市申请（孤儿药）。济川药业：现金储备约125亿元，家族企业，二代接班，管理层年轻化有利于创新。以BD赋能外延式扩张，与南京征祥医药合作的流感药物玛硒洛沙韦于2024年2月提交上市申请，与恒翼生物独家合作的PDE4抑制剂HPP737中重度斑块状银屑病III期临床进行中。悦康药业：中药属性逐步淡化，小核酸第一梯队。长效降脂小核酸药物YKYY015（靶向PCSK9 siRNA）注射液获批中美临床，有望实现一年仅需注射2次有效降脂。长效降压小核酸药物（靶向AGT siRNA）临床前研究成果登上国际知名期刊《Molecular Therapy-Nucleic Acids》，经过多项药效和毒理研究证实，抑制效率、药理作用持久性均优于罗氏/Alnylam的Zilebesiran，且安全性良好。佐力药业：参股凌意生物获得LY-N001（帕金森，基因治疗，IND）在中国大陆的经销权或销售代理权，扩大在先进疗法特别是神经领域相关管线的布局，多款基因治疗药物临床进行中。羚锐制药：2025年2月以7亿元完成收购银谷制药90%股权，获得1.1类新药必立汀（过敏性鼻炎）。九芝堂：重点布局干细胞创新领域，包括缺血耐受人同种异体骨髓间充质干细胞（缺血性脑卒中，II期）、人骨髓间充质干细胞（自身免疫性肺泡蛋白沉积，II期）、YB209（静脉血栓，II期）、YB211（ABSSSI，II期）。珍宝岛：参股公司浙江特瑞思药业抗CD20-ADC关键单臂注册II期进行中，2024年在ASCO披露Ib期数据，ORR为48.4%，DCR为78.1%，mPFS为5.4个月，1.8mg/kg剂量组疗效信号明显，ORR、DCR、mPFS分别为59.4%、87.5%和7.3个月，2024年3月获CDE纳入突破性治疗品种。华纳药厂：控股子公司致根医药自主开发的具有全新结构的新型抗抑郁药物ZG-001的IIa期临床进行中，预计2025完成。治疗中重度斑块状银屑病的ZG-002 I期临床进行中，预计2025完成。桂林三金：孙公司宝船生物注重生物药的创新性研发，适应症主要聚焦于肿瘤和自身免疫性疾病领域，研发靶点涵盖PD-L1、EGFR、CD47、CSF-1R、CLDN18.2，包含肿瘤微环境的各种方面的因素。CSF-1R单抗BC006 I期临床试验即将完成。众生药业：2024年中成药收入占比仍高达53%，但其成长性早已用创新药来丈量。流感新药昂拉地韦片2025年5月获批上市，国内唯一PB2靶点，可用于其他靶点耐药情况，验证差异化创新能力。GLP-1R/GIPR双靶点药物RAY1225具备两周给药一次的差异化优势，进入临床III期，位于国内第一阵营。MASH药物ZSP1601的IIb期临床进行中，具有改善肝脏炎症、坏死的潜力及抗纤维化的作用。越来越多中药企业投身创新，初心是打造第二成长曲线，也许会不知不觉把创新药变成主业。立足于充沛的现金流、敏感的商业嗅觉，中药企业将为创新药生态提供多样化的可能性。

专利到期抗体药物偶联物细胞疗法财报

2025-06-12

·阿基米德Biotech

中药蹭创新药热度，你也有今天

谁在中药里躲牛市？今年以来，中证中药指数下跌1.2%，而中证港股通创新药指数上涨71.6%。世界的悲喜并不同频，2023年，当创新药凄风冷雨之际，中药却感觉人生已经到达高潮，超六成中药上市公司业绩正增长，然而，高光时刻过于短暂，中药板块（75家中药上市公司）2024年营收同比-4.6%，净利润同比-18.7%，2025Q1颓势持续，营收同比-8.3%，净利润同比-5.7%。时代潮流浩浩荡荡，创新为王。中国创新药2024年对外授权交易金额达571亿美元，2025年初至今对外交易总金额已突破500亿美元，10项中国管线跻身2025年全球交易金额TOP20。中国创新药在细胞疗法、ADC、双抗领域在研管线数量全球第一，在716个赛道研发进度第一，有望继续依托License-out模式兑现创新价值。言必称BD，连中药企业也不例外。当片仔癀抱紧明朝宫廷秘方时，云南白药开始拥抱核药；当传统中药企业还在为集采扩面发愁时，京新药业自从开发精神类创新药，整个人都精神多了，众生药业在高景气赛道几乎全布局，走得太快，完全洗去中药的色彩（详见2024年1月《中药干了创新药的活》）。当前几年创新药卑微到尘埃里时，少数中药企业放着好日子不过，依靠丰厚的现金流，布局高风险项目，因为他们相信：创新是医药行业的大势所趋。01 中药加入吧，外面都是创新药的人了不是玩笑，外面真的都是创新药的人了。跨国药企面临专利悬崖，未来10年需要外购管线填补超2400亿美元市场空缺，而中国创新药凭借物美价廉优势，成为FIC/BIC潜力管线批量化供给的核心力量。2024 年重磅药物销售情况和专利信息（百万美元）27款2024年全球销售超过40亿美元的药品在美国将面临专利悬崖，以2024年销售额为准，合计潜在损失金额约2443亿美元。其中，涉及100亿美元级别药物共计9款，包括默沙东的K药、诺和诺德的司美格鲁肽、赛诺菲的度普利尤单抗、辉瑞的阿哌沙班、艾伯维的利生奇珠单抗、吉利德的Biktarvy、强生的达雷妥尤单抗、礼来的替尔泊肽以及Vertex的Trikafta。BMS：在来那度胺从2021年128亿美元全球峰值降低至2024年约58亿销售之后，目前主要面临的危机是阿哌沙班与O药两大“现金牛”的滑铁卢，两款产品均将在2027 年专利到期，2024年合计销售额达226亿美元。默沙东：未来五年，K药、西格列汀/二甲双胍、来特莫韦均将面临专利悬崖，仅K药2024年全球销售接近300亿美元，美国专利将在2029年到期。辉瑞：肿瘤药物lbrance、Xtandi以及关节炎药Xeljanz都将于2027年前专利到期。强生：肿瘤药物Darzalex、Erleada，肺动脉高压药物Opsumit、Uptravi，新血管药物Xarelto以及HIV药物Edurant将于2030年前专利到期。礼来：糖尿病药物Trulicity、Jardiance，关节炎药物Taltz以及肿瘤药物Cyramza将于2030年专利到期。TOP 10 MNC 的总市值和现金情况MNC均有迫切寻找重磅创新药的需求，而且全是膀大腰粗的金主，年度研发费用大部分超100亿美元，现金储备+可借债务基本上超100亿美元。MNC饿了来馒头，中国在各个创新领域在研管线数量不是全球第一就是全球第二，以青苗价无限供应FIC/BIC标的。细胞疗法、ADC、双抗、三抗/多抗、溶瘤病毒，中国在研管线数量超过美国，排名全球第一。PROTAC、基因疗法、小核酸药物、mRNA疫苗，中国也在追赶美国，差距较小。也许很快，中国在所有领域管线数量都达到全球第一。华福证券、医药魔方根据靶点和药品类型对创新药进行归类，将具有相同靶点和药品类型的创新药视为同一个赛道。全球在研创新药共覆盖3212个赛道，中国企业在研产品覆盖1300个赛道，覆盖度40%。中国产品在716个赛道（22%）的研发进度排名第一。相比之下，美国企业的在研产品覆盖1689个赛道，覆盖度53%，在其中1212个（38%）赛道研发进度排名第一。截至6月7日，2025年全球医药领域已完成443条交易，中国完成对外交易73条。2025年初至今，中国创新药对外交易总金额已超过500亿美金，占全球交易总金额的44%，首付款约25亿美金，占全球首付款的23%。首付款占比远低于总金额占比，原因在于，一是中国BD项目以早研管线为主，相对便宜，但研发进度位居全球前列，有机会成为MNC接替重磅品种专利悬崖的种子选手，二是中国创新药企经历凛冽寒冬后，心有余悸，惊魂未定，并没有耐心待价而沽，宁愿早卖贱卖。今年初至今的全球交易总金额 TOP20 项目今年初至今的全球交易总金额TOP20项目，来自中国的创新药管线有10项，占比50%，包括BioNTech的PM8002（来自普米斯）、三生制药/三生国健的SSGJ-707、和铂医药的早期管线，合作伙伴主要是MNC，包括BMS、AZ、辉瑞和默沙东。今年至今的全球交易首付款金额TOP20项目，来自中国的创新药管线有5项，占比25%。BioNTech的PM8002（来自普米斯）、三生制药SSGJ-707首付款均超过10亿美元。BD金额主要看首付款，首付款超1亿美元为大额BD，首付款超10亿美元为超级BD。中国创新药能从海外分成多少钱？2020年至今国内转国外授权交易总金额达1953亿美元。经华福证券测算，预计2020-2025年中国授权项目整体有望带来约82亿美元净利润，按10倍PE测算潜在市值增量达817亿美元。创新药牛市行至今日，有两个问题需要注意：你跑赢指数了吗？你能避开个股风险吗？相对完美的解决方案是配置ETF，港股创新药50ETF（513780）及其联接基金A/C（023597/023598）跟踪中证港股通创新药指数，近6个月区间涨幅达到52.5%。截至6月初，港股通创新药指数市盈率仅23.98倍，处于近三年历史分位数的0.64%，位置仍然不高，而且公募基金对医药板块仍处于低配状态，增量资金入场空间巨大。港股创新药50ETF（513780）前十大成分股为头部企业：信达生物、百济神州、药明生物、石药集团、康方生物、中国生物制药、三生制药、再鼎医药、药明康德（数据来源：Wind，截止日期：2025年6月11日）。创新药短期上涨较大且较快，呈现一定程度的交易拥挤，在市场调整时，也可能出现快速修正，但中长期来看，调整是布局港股创新药50ETF（513780）的窗口。2025年成为中国创新药海外大单品爆发的元年，大量预期峰值过30-50亿美元的品种浮出水面，重磅交易持续不断，头部企业将长期受益于BD红利。02下一波转型浪潮由中药企业掀起MNC补充管线是一个长周期过程，后发创新的中药企业仍来得及搭便车。上一波转型浪潮是由仿创药企发动，几乎所有Pharma都已成功上岸，包括恒瑞医药、翰森制药、石药集团、中国生物制药、三生制药、华东医药、科伦药业、先声药业，下一波转型浪潮有望由中药企业掀起，唯有创新方可避免类似疫苗行业的螺旋式向下命运，代表企业有众生药业（GLP-1、流感）、康缘药业（GLP-1）、京新药业（精神神经药物）、悦康药业（小核酸）、以岭药业（疼痛、脑卒中）、云南白药（核药）、天士力（双抗、ADC、干细胞）、济川药业（流感、PDE4）、佐力药业（AAV基因治疗）、珍宝岛（ADC）、华纳药厂（抗抑郁）、九芝堂（干细胞）、羚锐制药（过敏性鼻炎）、桂林三金（CSF-1R单抗）。中药企业部分创新管线梳理资料来源：Wind、中信建投康缘药业：最舍得研发的中药企业，2024年研发费用率16.37%。以2.7亿元收购中新医药100%股权，布局神经系统及代谢疾病，核心管线包括ZX1305 （视神经损伤，重组人神经生长因子，IIa期）、ZX1305E（神经营养性角膜炎，重组人神经生长因子，I期），当前最引人注目的是GLP-1/GIP/GCG三靶点药物ZX2021，减重适应症处于临床II期，国内进展第二，仅次于联邦制药，I期数据已读出，安全性/减重数据可对标礼来Retatrutide。小分子化药氟诺哌齐阿尔兹海默适应症，处于II期临床，年内推进III期。京新药业：披着仿创外衣的中药企业，2021年中西药收入占比约为8:2，拥有200多个中药批文库，随着失眠药大单品地达西尼2023年11月国内独家上市，完成华丽转身。治疗精神分裂症的1类创新药JX11502MA胶囊II期临床接近尾声。以岭药业：虽然争议满身，但进取心一直很饱满，2024年研发费用率12.69%，加大一类创新药研发力度，用于术后疼痛新药苯胺洛芬注射液已申报上市，治疗AML的FLT3抑制剂XY0206的III期临床进行中。云南白药：加速推进核药管线，用于前列腺癌PET成像的INR101已在2025年5月开始III期入组，用于前列腺癌治疗的INR102处在I/IIa期。天士力：屡败屡战，创新永不言弃，2024年研发费用率9.77%，PD-L1/VEGF双抗B1962进入II期临床，FGF21靶点NASH药物Ia期试验完成统计报告，靶向CD44、CD133的自体CAR-T获批IND，罕见病腓骨肌萎缩症治疗药物PXT3003于2025年4月提交上市申请（孤儿药）。济川药业：现金储备约125亿元，家族企业，二代接班，管理层年轻化有利于创新。以BD赋能外延式扩张，与南京征祥医药合作的流感药物玛硒洛沙韦于2024年2月提交上市申请，与恒翼生物独家合作的PDE4抑制剂HPP737中重度斑块状银屑病III期临床进行中。悦康药业：中药属性逐步淡化，小核酸第一梯队。长效降脂小核酸药物YKYY015（靶向PCSK9 siRNA）注射液获批中美临床，有望实现一年仅需注射2次有效降脂。长效降压小核酸药物（靶向AGT siRNA）临床前研究成果登上国际知名期刊《Molecular Therapy-Nucleic Acids》，经过多项药效和毒理研究证实，抑制效率、药理作用持久性均优于罗氏/Alnylam的Zilebesiran，且安全性良好。佐力药业：参股凌意生物获得LY-N001（帕金森，基因治疗，IND）在中国大陆的经销权或销售代理权，扩大在先进疗法特别是神经领域相关管线的布局，多款基因治疗药物临床进行中。羚锐制药：2025年2月以7亿元完成收购银谷制药90%股权，获得1.1类新药必立汀（过敏性鼻炎）。九芝堂：重点布局干细胞创新领域，包括缺血耐受人同种异体骨髓间充质干细胞（缺血性脑卒中，II期）、人骨髓间充质干细胞（自身免疫性肺泡蛋白沉积，II期）、YB209（静脉血栓，II期）、YB211（ABSSSI，II期）。珍宝岛：参股公司浙江特瑞思药业抗CD20-ADC关键单臂注册II期进行中，2024年在ASCO披露Ib期数据，ORR为48.4%，DCR为78.1%，mPFS为5.4个月，1.8mg/kg剂量组疗效信号明显，ORR、DCR、mPFS分别为59.4%、87.5%和7.3个月，2024年3月获CDE纳入突破性治疗品种。华纳药厂：控股子公司致根医药自主开发的具有全新结构的新型抗抑郁药物ZG-001的IIa期临床进行中，预计2025完成。治疗中重度斑块状银屑病的ZG-002 I期临床进行中，预计2025完成。桂林三金：孙公司宝船生物注重生物药的创新性研发，适应症主要聚焦于肿瘤和自身免疫性疾病领域，研发靶点涵盖PD-L1、EGFR、CD47、CSF-1R、CLDN18.2，包含肿瘤微环境的各种方面的因素。CSF-1R单抗BC006 I期临床试验即将完成。众生药业：2024年中成药收入占比仍高达53%，但其成长性早已用创新药来丈量。流感新药昂拉地韦片2025年5月获批上市，国内唯一PB2靶点，可用于其他靶点耐药情况，验证差异化创新能力。GLP-1R/GIPR双靶点药物RAY1225具备两周给药一次的差异化优势，进入临床III期，位于国内第一阵营。MASH药物ZSP1601的IIb期临床进行中，具有改善肝脏炎症、坏死的潜力及抗纤维化的作用。越来越多中药企业投身创新，初心是打造第二成长曲线，也许会不知不觉把创新药变成主业。立足于充沛的现金流、敏感的商业嗅觉，中药企业将为创新药生态提供多样化的可能性。

抗体药物偶联物专利到期引进/卖出财报

2025-06-11

·investor.jnj.com

New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis

TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis BARCELONA, June 11, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 3b APEX study showing that TREMFYA® (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo.1 These data from a late-breaking abstract are among the 30 oral and poster presentations Johnson & Johnson is highlighting at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress. In the Phase 3b APEX study, TREMFYA® significantly inhibited progression of joint structural damage, including joint erosions and space narrowing, in patients with active PsA at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score. The mean change from baseline to Week 24 in the modified van der Heijde-Sharp (vdH-S) score was 0.55 and 0.54 for patients receiving TREMFYA® every four weeks (Q4W) and every eight weeks (Q8W) respectively, compared with 1.35 in the placebo group (p=0.002 for Q4W and p<0.001 for Q8W dosing versus placebo, respectively). In the two TREMFYA® dose groups, 67% (Q4W) and 63% (Q8W) of patients experienced no radiographic progression, versus 53% in the placebo group.a,1 "In psoriatic arthritis, joint damage can begin early and progress quickly if left untreated, significantly impacting a patient's ability to move, work and maintain independence," said Philip J. Mease, MD, Director of Rheumatology Research at the Swedish Medical Center and study investigator.b "The results of the APEX study are promising as the data show guselkumab to be the only IL-23 inhibitor in its class that has inhibited the progression of structural damage in patients, providing new clinical insights for the psoriatic community and underscoring the need for safe, effective options that address the full burden of disease." TREMFYA® also improved both joint and skin symptoms in patients with active PsA. Significantly greater proportions of TREMFYA®-treated patients (67% for Q4W and 68% for Q8W) achieved American College of Rheumatology response criteria (ACR20c) at Week 24 versus 47% receiving placebo (p<0.001) More than twice as many patients treated with TREMFYA® achieved ACR50c (41% for Q4W and 42% for Q8W) versus 20% receiving placebo at Week 24.1 In assessing skin clearance, greater proportions of TREMFYA®-treated patients (73% for Q4W and 68% for Q8W) achieved an Investigator's Global Assessment (IGA) score of 0/1d (clear or almost clear skin) at Week 24 versus 31% receiving placebo.1 The data from the APEX study were consistent with the well-established safety profile of TREMFYA®, with no new safety signals identified.1 "With these results from the APEX study, TREMFYA has set a new bar for joint preservation as the only IL-23 inhibitor proven to significantly inhibit structural damage in active psoriatic arthritis, an inflammatory arthritis that can develop in up to 30% of people living with psoriasis," said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "The efficacy and safety profile of TREMFYA offers psoriatic healthcare providers and patients an innovative option for disease control." TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.2,3,4,5,6 Editor's notes: a. TREMFYA is not approved for Q4W dosing in the U.S. b. Dr. Philip J. Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.c. ACR20/50 response is defined as both at least 20/50 percent improvement from baseline in the number of tender and number of swollen joints, and a 20/50 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.8 ABOUT THE APEX STUDY (NCT04882098) APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.9 ABOUT PSORIATIC ARTHRITIS Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).10,11,12 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.13 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.14 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.15 Studies show up to 30% of people with plaque PsO also develop PsA.11 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease.16 TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com. IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: o fainting, dizziness, feeling lightheaded (low blood pressure) o swelling of your face, eyelids, lips, mouth, tongue or throat o trouble breathing or throat tightness o chest tightness o skin rash, hives o itching Infections. TREMFYA® 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 TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® 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 TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes o nausea o stomach pain (abdominal) o loss of appetite o dark urine Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, 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 TREMFYA®?" 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). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. 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 TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/ Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. REFERENCES 1 Mease PJ, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Presented at EULAR 2025, June 11-14. LB0010.2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.7 Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. https://doi.org/10.1186/ar44288 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.04.104. Accessed April 2025.9 ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: https://clinicaltrials.gov/study/NCT04882098. Accessed March 2025.10 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed March 2025.11 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed.ncbi.nlm.nih.gov/31102105/. Accessed March 2025.12 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed March 2025.13 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed March 2025.14 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed March 2025.15 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed March 2025.16 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed March 2025. Media contact:Craig Stoltz cstoltz@its.jnj.com Investor contact:Lauren Johnsoninvestor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/new-data-show-tremfya-guselkumab-is-the-only-il-23-inhibitor-proven-to-significantly-inhibit-progression-of-joint-structural-damage-in-active-psoriatic-arthritis-302475588.html SOURCE Johnson & Johnson

临床结果临床3期上市批准

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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临床结果

适应症

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


NCT04435600 (OptIMMize-1, CTgov)	临床3期	斑块状银屑病 \| 慢性大斑块银屑病	139	Risankizumab (Part 1: Risankizumab)	鹹淵廠餘鹽繭衊餘製顧 = 鬱壓簾蓋艱網廠構醖鏇蓋艱夢積構選願網鏇繭 (願範壓網鹽網製夢壓繭, 鬱構淵艱繭鹽膚顧艱艱 ~ 廠簾鏇製選糧選積選淵) 更多	-	2025-05-20
				Ustekinumab (Part 2 Period A: Ustekinumab)	鹹淵廠餘鹽繭衊餘製顧 = 艱獵構網鹹艱繭遞簾夢蓋艱夢積構選願網鏇繭 (願範壓網鹽網製夢壓繭, 衊廠齋淵獵餘選膚餘獵 ~ 鑰醖艱壓觸構範顧築簾) 更多
ADVANCE, MOTIVATE, FORTIFY (Pubmed \| J Crohns Colitis)	临床3期	克罗恩病引起的肛周瘘维持 high-sensitivity C-reactive protein (hs-CRP) \| fecal calprotectin (FCP)	748	Risankizumab 600 mg	鬱襯鹽餘鑰繭獵鹹鏇築(淵構淵齋憲淵構窪餘衊) = 衊積鹽蓋廠積簾選網壓齋衊範鑰願網蓋願衊鹽 (衊膚齋憲網膚遞襯願廠 ) 更多	积极	2025-04-04
				Risankizumab 180 mg	鬱襯鹽餘鑰繭獵鹹鏇築(淵構淵齋憲淵構窪餘衊) = 顧鬱憲繭夢廠夢鏇願網齋衊範鑰願網蓋願衊鹽 (衊膚齋憲網膚遞襯願廠 ) 更多
NCT03105128 (MOTIVATE, ADVANCE, FORTIFY, Pubmed \| Clin Gastroenterol Hepatol)	临床3期	克罗恩病引起的肛周瘘 anti-interleukin-23 p19 monoclonal antibody	-	Risankizumab 1200 mg IV	鹹淵夢範窪鹹鑰齋願淵(積餘襯衊壓糧觸壓蓋餘) = 製壓獵夢構糧網淵夢範積鬱築築艱顧遞築網齋 (衊齋鑰觸膚簾壓築鹽選 ) 更多	积极	2025-02-01
				Risankizumab 180 mg SC	鹹淵夢範窪鹹鑰齋願淵(積餘襯衊壓糧觸壓蓋餘) = 遞簾襯繭選廠鹽齋築淵積鬱築築艱顧遞築網齋 (衊齋鑰觸膚簾壓築鹽選 ) 更多
FORTIFY (Pubmed \| Gastro Hep Adv)	临床3期	克罗恩病维持	-	Risankizumab	獵糧鹹蓋遞廠廠壓願選(顧積糧餘積顧鑰繭憲廠) = 願網夢願獵壓製觸糧鹹廠艱鑰淵築醖獵遞鏇獵 (積簾夢窪艱築網鏇醖獵 )	积极	2025-01-01
NCT03047395 (LIMMitless, CTgov)	临床3期	斑块状银屑病 \| 慢性大斑块银屑病	2,170	Risankizumab	衊鹽觸蓋獵鏇壓衊襯衊 = 鹽壓衊襯獵顧築築壓構遞願積廠獵糧鹽壓餘壓 (廠觸膚簾廠製製廠鏇遞, 顧積窪艱糧襯壓衊積餘 ~ 觸淵觸願鹹醖憲選鬱繭) 更多	-	2024-12-11
NCT04524611 (SEQUENCE, UEGW2024)	临床3期	克罗恩病	-	Risankizumab	築蓋蓋齋蓋醖鏇糧鬱遞(鏇觸繭鏇蓋構獵繭憲膚) = 廠膚衊夢醖淵範繭築齋顧襯蓋鹹構齋鹽鏇襯鹽 (壓襯夢夢顧構憲憲憲淵, 48.2 ~ 79.6) 更多	积极	2024-10-13
				Ustekinumab	築蓋蓋齋蓋醖鏇糧鬱遞(鏇觸繭鏇蓋構獵繭憲膚) = 構醖廠壓淵遞繭鹹遞醖顧襯蓋鹹構齋鹽鏇襯鹽 (壓襯夢夢顧構憲憲憲淵, 36.2 ~ 66.1) 更多
NCT03398148 \| NCT03398135 (INSPIRE \| COMMAND, UEGW2024)	临床3期	溃疡性结肠炎维持 high-sensitivity C-reactive protein	650	Risankizumab 1200 mg IV	鏇憲膚膚鏇餘淵選網構(壓積鏇遞鹹遞簾鬱繭艱) = 製夢網膚膚鏇築構築選構憲齋衊蓋壓糧齋鬱餘 (鹽廠淵膚醖憲構鑰鬱網, 18.4 ~ 26.8) 更多	积极	2024-10-13
				Placebo IV	鏇憲膚膚鏇餘淵選網構(壓積鏇遞鹹遞簾鬱繭艱) = 積衊餘鬱膚築艱鏇鑰餘構憲齋衊蓋壓糧齋鬱餘 (鹽廠淵膚醖憲構鑰鬱網, 4.1 ~ 11.9) 更多
NCT03105102 (FORTIFY, UEGW2024)	临床3期	活动性中度克罗恩病维持 interleukin-23 p19 subunit	710	Risankizumab 180 mg	窪鑰獵鑰壓範醖製鬱網(夢鹹蓋窪鬱構製範簾構) = 構築憲鑰蓋鹽積製鑰廠膚醖獵餘衊積鑰願願衊 (襯膚製醖築餘淵壓壓艱 ) 更多	积极	2024-10-13
				Risankizumab 360 mg	窪鑰獵鑰壓範醖製鬱網(夢鹹蓋窪鬱構製範簾構) = 網鑰鏇範選繭膚範壓製膚醖獵餘衊積鑰願願衊 (襯膚製醖築餘淵壓壓艱 ) 更多
NCT04524611 (SEQUENCE, UEGW2024)	临床3期	克罗恩病	-	Risankizumab	夢壓膚網鹹選襯蓋餘壓(簾顧獵網鏇餘積鏇衊鏇) = 齋範襯衊範獵鏇夢醖鹹鹹衊餘蓋蓋積廠獵製艱 (積窪顧鏇餘齋蓋憲襯餘 ) 更多	积极	2024-10-13
				Ustekinumab	夢壓膚網鹹選襯蓋餘壓(簾顧獵網鏇餘積鏇衊鏇) = 觸齋醖顧觸構鏇鑰鏇願鹹衊餘蓋蓋積廠獵製艱 (積窪顧鏇餘齋蓋憲襯餘 ) 更多
UEGW2024	N/A	活动性中度溃疡性结肠炎	-	Risankizumab 1200 mg IV	餘衊鹽觸衊鹹鏇鹽遞憲(齋簾齋鑰顧選鏇廠鹹鬱) = 餘鹹廠醖製壓夢願鬱範襯淵獵蓋鹽顧衊繭淵遞 (衊窪齋獵廠選餘顧齋鑰 )	-	2024-10-13
				Placebo IV	餘衊鹽觸衊鹹鏇鹽遞憲(齋簾齋鑰顧選鏇廠鹹鬱) = 廠鏇襯顧鏇廠鹹願淵餘襯淵獵蓋鹽顧衊繭淵遞 (衊窪齋獵廠選餘顧齋鑰 )