培塞利珠单抗(Certolizumab Pegol) - 药物靶点：TNF-α_在研适应症：红皮病性银屑病，寻常性银屑病，脓疱型银屑病_专利_临床

概要

基本信息

药物类型

Fab片段抗体

别名

AutoClicks-Prefilled-Pen、Certolizumab、Certolizumab Pegol (Genetical Recombination)

+ [12]

靶点

TNF-α

作用机制

TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [5]

在研适应症

红皮病性银屑病寻常性银屑病脓疱型银屑病+ [13]

非在研适应症

无精子症脑损伤溃疡性结肠炎+ [6]

原研机构

UCB SA

在研机构

UCB Biopharma SRLUCB Pharma Ltd.UCB BioSciences GmbH

+ [5]

非在研机构

UCB Pharma GmbHKorea Otsuka Pharmaceutical Co., Ltd.UCB BioSciences, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2008-04-22),

克罗恩病

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构/序列

Sequence Code 7540H

来源: *****

Sequence Code 99012L

来源: *****

关联

122

项与培塞利珠单抗相关的临床试验

NCT05930613

/ Recruiting临床3期IIT

Efficacy of Certolizumab in Women With Unexplained Recurrent Implantation Failure: a Double-blind Randomized Controlled Trial

Recurrent implantation failure (RIF), defined as the absence of clinical pregnancy after the transfer of three good-quality embryos, concerns up to 40% of IVF couples and is associated with a low success rate. The causes remain unexplained in over 50% of cases.
Various dysimmune changes (related to immune T cells profiles, pro-inflammatory cytokines levels) have been described in unexplained RIF as compared to fertile controls, and it has been estimated that such dysimmunity may occur in 50% of unexplained RIFs. Previous data on a benefit of general immune modulation by steroids or immunoglobulins are heterogenous and failed to demonstrate clinically significant benefit. The proinflammatory cytokine Tumor Necrosis Factor (TNF) α participates in the regulation of the immune balance of the endometrium, its peripheral blood and endometrial concentrations are increased in RIF patients as compared to fertile controls. In 2009, a pilot placebo controlled study showed that TNF-α antagonist treatment allowed a 56% live birth rate (versus 13% in controls) in 13 women with unexplained RIF. Due to the lack of maternal and fetal tolerance data, TNF-α antagonists were not further evaluated. Today, safety data issued from 1200 pregnancies are reassuring allowing the use of TNF-α antagonists during pregnancy (www.lecrat.org). In addition the TNF-α antagonist certolizumab does not cross the placental barrier.
We hypothesize that certolizumab may improve clinical pregnancy rates in women with unexplained RIF with a good safety profile.

开始日期2023-11-30

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT06028438

/ Completed临床2期

A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)

The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

开始日期2023-08-15

申办/合作机构

Janssen Research & Development LLC

NCT05115903

/ Active, not recruiting临床4期IIT

A Prospective, Randomized Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

Current evidence on tapering of tumor necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) is still hampered by heterogeneity in tapering regimens, selection and performance biases, and lack of data on optimized treatment dosing strategies especially in real-world clinical settings. This study aims to contribute to the ongoing investigation of disease-activity-guided tapering of TNFi in axSpA in the form of a prospective, randomized controlled trial.

开始日期2021-12-01

申办/合作机构

University Health Network

100 项与培塞利珠单抗相关的临床结果

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100 项与培塞利珠单抗相关的转化医学

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100 项与培塞利珠单抗相关的专利（医药）

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1,110

项与培塞利珠单抗相关的文献（医药）

2025-01-01·PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR

Anxiety modulators elicit different behavioral outcomes in adult zebrafish: Emphasis on homebase-related parameters and spatio-temporal exploration

Article

作者: Moraes, Hevelyn S. ; Silva, Rossano M. ; Resmim, Cássio M. ; Gonçalves, Falco L. ; Rosemberg, Denis B. ; Moraes, Hevelyn S ; Gonçalves, Falco L ; Rosemberg, Denis B ; Sauter, Milena D. ; Silva, Rossano M ; Sauter, Milena D ; Pretzel, Camilla W ; Resmim, Cássio M ; Pretzel, Camilla W. ; Borba, João V ; Borba, João V.

Anxiety is an emotion that represents a crucial anticipatory reaction of aversive stimuli, with clinical relevance in cases of disproportional and severe occurrences. Although distinct animal models have contributed to elucidate anxiety-related mechanisms, the influence of anxiogenic and anxiolytic modulations on both locomotion and exploration-related parameters in the open field test (OFT) is not fully elucidated. Here, we aimed to assess the influence of anxiogenic and anxiolytic manipulations on the exploratory dynamics of adult zebrafish (Danio rerio) focusing on homebase-related behaviors. As anxiogenic manipulations, we used the morphine (1.5 mg/L) withdrawal protocol (MOR); 3.5 mL/L conspecific alarm substance (CAS) for 5 min; and 100 mg/L caffeine (CAF) for 15 min. To evoke anxiolytic-like responses, animals were acutely exposed to 0.5 % (v/v) ethanol (ETOH) for 1 h; 100 μg/L fluoxetine (FLU) for 15 min; and 0.006 mg/L clonazepam (CZP) for 10 min. Then, fish were individually exposed to the 30-min OFT trial, with posterior analysis of behavioral activity. While MOR induced hyperlocomotion and increased periphery occupancy, CAS and CAF groups showed higher immobility and increased latency to homebase formation, respectively. Conversely, ETOH and FLU reduced homebase occupancy, supporting anxiolytic-like behaviors, while CZP did not change zebrafish behavior in the OFT. Cluster analysis was used to reconfirm the remarkable similarities and discrepancies between treatments, thus contributing to characterize the distinct responses measured. Overall, our novel data show the relevance of homebase-related analysis as a sensitive tool to reflect affective-like states in zebrafish, providing innovative approaches to unravel the spatio-temporal dynamics of anxiety-like behaviors in vertebrates.

2025-01-01·ACR open rheumatology

Circulating Baseline CXCR3⁺Th2 and Th17 Cell Proportions Correlate With Trabecular Bone Loss After 48 Weeks of Biological Treatment in Early Rheumatoid Arthritis

Article

作者: van Vollenhoven, Ronald ; Lorentzon, Mattias ; Lindholm, Catharina ; Hultgård Ekwall, Anna‐Karin ; Drevinge, Christina ; Østergaard, Mikkel ; Hørslev‐Petersen, Kim ; Islander, Ulrika ; Lund Hetland, Merete ; Lampa, Jon ; Nordström, Dan ; Sokka‐Isler, Tuulikki ; Schrumpf Heiberg, Marte ; Gudbjornsson, Bjorn ; Uhlig, Till ; Carlsten, Hans ; Nurmohamed, Michael T. ; Gröndal, Gerdur ; Gjertsson, Inger ; Rudin, Anna ; Haavardsholm, Espen A. ; Scheffler, Julia M. ; Lend, Kristina

Objective:

The high prevalence of osteoporosis in rheumatoid arthritis (RA) is due to inflammation that stimulates differentiation of osteoclasts, a process involving circulating monocytes and T cell–derived factors. The aim of this study was to evaluate relations between circulating monocytes, T cell subsets, and changes in bone characteristics before and after treatment with biological disease‐modifying antirheumatic drugs (bDMARDs) in RA.

Methods:

Thirty patients with untreated early RA who met the American College of Rheumatology/EULAR 2010 criteria were included. Data were collected before and 48 weeks after treatment with methotrexate (MTX) together with one of three bDMARDs (abatacept, tocilizumab, or certolizumab pegol). Disease activity was measured using the Clinical Disease Activity Index, swollen or tender joint counts, C‐reactive protein levels, and erythrocyte sedimentation rates. Proportions of monocyte and CD4+ T cell subsets in blood samples were analyzed by flow cytometry. Bone densitometry was performed using high‐resolution peripheral quantitative computed tomography (HR‐pQCT).

Results:

HR‐pQCT revealed an overall decrease in cortical (P = 0.009) and trabecular (P = 0.034) bone mineral density, although a subset of patients showed no bone loss after 48 weeks of treatment. The overall bone loss was not associated with age, body mass index, sex, intraarticular glucocorticoid injections, or baseline disease activity. Loss of trabecular bone volume fraction correlated with high proportions of circulating CXCR3+Th2 cells (r = −0.38, P = 0.04) and CXCR3+Th17 cells (r = −0.36, P = 0.05) at baseline. Similarly, no loss of trabecular bone volume fraction correlated with high proportions of regulatory T cells (r = 0.4, P = 0.03) at baseline. However, the associations were not significant when corrected for confounders and multiple testing.

Conclusion:

MTX together with bDMARDs efficiently reduce disease activity but only prevent bone loss in a subset of patients with RA after 48 weeks of treatment. The correlations of circulating baseline T helper cell and regulatory T cell populations with trabecular bone changes suggest a potential novel role for these cells in systemic bone homeostasis during early RA.

2024-12-01·INTERNATIONAL JOURNAL OF DERMATOLOGY

Certolizumab pegol effectiveness, survival and safety in patients with psoriasis: A multicenter retrospective analysis in daily clinical practice by the Spanish Psoriasis Group

Article

作者: Notario, Jaime ; Gallardo, Fernando ; Sahuquillo‐Torralba, Antonio ; Vidal, David ; Llamas‐Velasco, Mar ; Ruiz Villaverde, Ricardo ; Gonzalez‐Delgado, Víctor ; Urruticoechea‐Arana, Ana ; Mollet, Jordi ; Belinchón Romero, Isabel ; Mansilla‐Polo, Miguel ; Rull, Eva V. ; Riera‐Monroig, Josep ; Lopez, Anna ; Pujol‐Marco, Conrad ; Beltran, Emma ; Carrascosa, José M. ; Pitarch, Gerard ; Alsina, Merce ; Ferran, Marta ; Ribera, Miquel

Abstract:

Background:

Certolizumab is an Fc‐free PEGylated tumor necrosis factor‐alpha (TNFα) inhibitor recently approved for the treatment of moderate‐to‐severe plaque psoriasis, although there is limited real‐world evidence on the effectiveness and safety in patients with plaque psoriasis treated with certolizumab.The objective of this article is to determine the effectiveness, drug survival, and safety, including pregnancy, childbirth, and lactation, of certolizumab in moderate‐to‐severe plaque psoriasis under real‐world conditions.

Methods:

This is a retrospective, multicenter, observational study performed in 15 hospitals in Spain. It evaluates the effectiveness and safety of certolizumab in plaque psoriasis in the clinical practice setting.

Results:

A total of 67 patients (73% female) were evaluated with a mean baseline Psoriasis Area Severity Index (PASI) of 8.9. At Week 12, the mean PASI was 2.3 (n = 67), 1.3 (n = 57) at Week 24 and 1.3 at Week 52 (n = 34). Absolute PASI < 3 was achieved in 69, 86, and 92% of patients at Weeks 12, 24, and 52, respectively, as observed. For its part, using the under‐response imputation analysis, PASI < 3 at Weeks 12, 24, and 52 were achieved by 69, 73, and 49% of the patients, respectively. A total of 35 patients (52%) had concomitant psoriatic arthritis, and, in 24 of them, Disease Activity in Psoriatic Arthritis Score (DAPSA) was recorded at baseline, with a mean value of 17.9 which decreased to 8.2 at Week 12 (n = 22) and to 3.6 at Week 24 (n = 18). Certolizumab treatment was discontinued in 14 out of 67 patients (21%), due to lack/loss of cutaneous or articular effectiveness (n = 11) or patient decision (n = 2) or adverse event in only one patient who developed active tuberculosis. A lower baseline PASI [hazard ratio (HR): 1.12 (1.02–1.23); P = 0.023] and a more significant reduction in PASI at Week 12 [HR: 1.16 (1.07–1.27); P < 0.001] and Week 52 [HR: 1.47 (1.11–1.96); P = 0.007] was shown to be significantly related with better survival for the entire follow‐up period. Fourteen patients were treated during pregnancy and/or lactation without reporting adverse events in either the patient or the newborn.

Conclusions:

Certolizumab consistently showed high effectiveness and drug survival rates in this real‐life cohort. The safety demonstrated in clinical trials during pregnancy and lactation seems to be confirmed in clinical practice.

56

项与培塞利珠单抗相关的新闻（医药）

2024-12-11

·凯莱英药闻

全球第二，潜在“最佳”！国产首创IL-17A/F抗体药物治疗强直性脊柱炎（AS）达III期临床终点

欢迎关注凯莱英药闻今日，鑫康合生物医药宣布，公司开发的XKH004完成治疗强直性脊柱炎(AS)的III期临床研究首次分析，成功达到试验的临床终点。 XKH004是一款IL-17A/F抑制剂，由丽珠医药和鑫康合生物合作研发，也是国产进展最快的IL-17A/F双靶点药物。关于III期临床最新数据该III期临床是一项多中心、随机、双盲、安慰剂对照试验，共入组323例中重度活动性AS受试者，结果显示：主要终点：采用160mg每四周一次（Q4W）XKH004药物治疗的受试者，第16周ASAS40应答率显著高于安慰剂组（45.5% XKH004 vs 19.4% PBO；P＜0.001），且在接受过 TNFi 治疗的和未接受过TNFi治疗的患者亚组中的疗效趋势是一致的。关键次要终点：第16周ASAS20应答率也具有显著差异(62.2% XKH004 vs 34.8% PBO；P＜0.001)；其他次要疗效指标，包括ASAS50、ASAS70、ASAS5/6、总背痛评分、炎症评分、hs-CRP、ESR、ASDAS-CRP、ASDAS-ESR等，治疗组表现也均显著优于安慰剂组。在安全性上，药物总体耐受性良好，大多数患者发生的TEAE均为Ⅰ-Ⅱ级，XKH004组和安慰剂组的总体不良事件（AE）发生率相当，与已上市的同类药物不良事件（AE）发生率相当，未发现新的安全性信号。关于XKH004 XKH004是一款可同时靶向IL-17A和IL-7F的IgG1型人源化单克隆抗体，通过阻断IL-17A/F与其受体的相互作用而抑制下游炎症信号通路，目前正开发用于中重度斑块型银屑病、强直性脊柱炎等自身免疫相关的适应症，具有同类最佳的治疗潜力。关于IL-17药物 IL-17（白介素-17）是促炎细胞因子家族，主要由Th17细胞产生，包括IL-17A-IL-17F六个家族成员，共有IL-17RA-RD和SEF五个受体。IL-17能够诱导多种趋化因子、细胞因子、抗菌肽等释放，参与免疫系统调控。该靶点在多种疾病中发挥作用，包括自身免疫疾病、癌症、感染等。近期，NMPA批准恒瑞医药的IL-17A单抗夫那奇珠单抗、智翔金泰的IL-17A 单抗赛立奇单抗上市，成为国内市场头两个获批上市的国产IL-17A；除此以外，国内市场已获批司库奇尤单抗、依奇珠单抗、布罗利尤单抗、比吉利珠单抗等4 款进口IL-17靶点相关生物药，仅比吉利珠单抗为IL-17A/F双靶点药物。据不完全统计，目前处于临床阶段的在研IL-17药物约30余种。根据PDB 国内药品终端市场销售数据，国内IL-17 靶点相关生物药主流药物司库奇尤单抗、依奇珠单抗在2023 年的销售额分别为37.64亿元、3.34 亿元，合计销售额达40.98 亿元；未来，IL-17 靶点相关生物药的上市销售其市场规模有望进一步扩大。关于强直性脊柱炎 AS属于炎症性全身性免疫疾病，可导致脊柱强直、畸形、易致残，且发病可累及全身多器官，如眼、皮肤、肠道等。据弗罗斯特沙利文测算，2020 年中国AS 患病人数为389.5万人，预计到2030 年将达到405.4 万人。目前，AS 尚无根治方法，其治疗目标是缓解疼痛、僵硬和疲劳，同时维持良好的姿势以及良好的生理和心理功能。用药方面，目前治疗主要是一线NSAIDs（非甾体抗炎药）和二线生物制剂。NSAIDs 疗效有限、副作用大；生物制剂以TNFα 制剂为主，包括依那西普、英夫利昔单抗、阿达木单抗、赛妥珠单抗等，可能导致继发性失效、注射给药依从性差的问题，临床仍存在未被满足的需求。近年来，中国AS 药物市场由2017 年的12 亿美元增加至2021年的16 亿美元，复合年增长率为6.8%。预计2030 年将达到67 亿美元，2021年至2030 年复合年增长率为17.1%。强直性脊柱炎患病人数和市场规模(百万美元/百万人) 参考资料 1、公司官网 2、华创证券、国投证券、华源证券、国泰君安证券、太平洋证券感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

上市批准临床3期临床结果临床成功

2024-10-29

·PRNewswire

Genascence Appoints Jeymi Tambiah as Chief Medical Officer

—Accomplished physician-scientist with more than 15 years' biopharmaceutical industry experience in medical affairs, clinical development, and drug development —Visionary leader skilled at leveraging scientific and clinical expertise to build innovative first-in-class therapeutic programs in areas of osteoarthritis, immunology, oncology, and neuroscience PALO ALTO, Calif., Oct. 29, 2024 /PRNewswire/ -- Genascence Corporation ("Genascence"), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, today announced the appointment of Jeymi Tambiah, MBChB, FRCS, MS, FAPCR, MFPM(Dis) as its chief medical officer. Dr. Tambiah is an accomplished physician-scientist with more than 15 years' biopharmaceutical industry experience creating and leading strategies for medical affairs, clinical development, and drug development programs. He also brings deep experience in translational medicine, commercialization, and health outcomes research to Genascence. Continue Reading Jeymi Tambiah, Chief Medical Officer, Genascence "Jeymi is a visionary leader skilled at leveraging scientific and clinical expertise to build innovative first-in-class therapeutic programs in the areas of osteoarthritis, immunology, oncology, and neuroscience and I am excited to welcome him to Genascence as our chief medical offer," said Thomas Chalberg, Ph.D., founder and CEO of Genascence. "His experience includes all phases of drug development from bench through Phase 1-4 clinical studies and building elite high performance medical affairs teams. Jeymi's development and research expertise, particularly within the osteoarthritis research community, will be invaluable as we execute on our strategy to bring gene therapy to people suffering from prevalent musculoskeletal diseases." "Genascence is a company that is transforming how we treat debilitating musculoskeletal diseases like osteoarthritis by pioneering the development of gene therapy," said Dr. Tambiah. "I am thrilled to join this outstanding team under Tom's leadership and apply my knowledge and experience to advance our clinical program so that we can bring potentially curative therapies to patients in desperate need of better treatments." Before joining Genascence, Jeymi was senior vice president of clinical development and external innovation at Biosplice Therapeutics, a start-up biotech developing molecules modulating mRNA splicing in oncology, arthritis, and neurodegenerative diseases, where he was primarily responsible for clinical development, medical affairs, and external thoughtleader and scientific partnerships. Previously, Jeymi worked for UCB Pharma in various roles of increasing leadership within medical affairs, launching the TNF-inhibitor certolizumab pegol within the European Union, U.K., and U.S. across multiple immunology indications. Before his move into pharma, Jeymi trained and practiced in cardiothoracic surgery at Guys' and St. Thomas' Hospitals in London. Jeymi is very active in the osteoarthritis research community, with numerous research awards and publications, holding many committee appointments, and regularly presenting at international conferences. He is the North American representative for the Faculty of Pharmaceutical Medicine UK, and in this role is dedicated to supporting the education and mentoring of physicians in drug development. Jeymi earned his medical degree from the University of Manchester, UK, a doctorate degree in vascular biology from Imperial College London where he was a Wellcome Research Fellow, and a BSc (Hons) in medical science from the University of St. Andrews, UK. He is a fellow of the Royal College of Surgeons of England and Edinburgh, a member of Faculty of Pharmaceutical Physicians UK by Distinction, and a fellow of the Academy of Physicians in Clinical Research. About Genascence Corporation Genascence, a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, is developing life-changing treatments for highly prevalent conditions affecting millions of people. The company was founded in 2017 with technology licensed from three leading U.S. research institutions: Mayo Clinic, University of Florida, and NYU Langone Health. Headquartered in Palo Alto, California, Genascence's founders and leadership team have deep experience in the design, development, and manufacturing of successful gene therapies and biological medicines. For more information, please visit . SOURCE Genascence WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更基因疗法

2024-10-22

·医药笔记

优时比：罗氏退回Tau抗体全球权益

▎Armstrong 2024年10月22日，优时比宣布Tau抗体Bepranemab治疗潜伏期至轻度阿尔茨海默症的2a期TOGETHER临床数据将在今年CTAD会议上报告，该会议的时间是10月29日至11月1日。同时，优时比宣布合作伙伴罗氏旗下基因泰克退回了Bepranemab的全球权益。 Bepranemab是一种重人源化的IgG4亚型的Tau抗体，可特异性靶向tau的中间区域（氨基酸235-250），靠近微管结合区（MTBR）。研究认为，与靶向tau其他区域（即N端）的抗体相比，中间区域抗体可以更有效地干扰致病性tau聚集体的细胞间传播。总结优时比在抗体领域布局了不少独具特色的产品，除了此次被退回的Tau抗体外，还有唯一一款PEG修饰的TNFα抗体Cimzia，也是其目前最畅销的创新药，年销售额20亿美元左右。Bimzelx为全球首款IL-17A/F抗体，今年上半年销售额2.15亿欧元，放量迅速。Rystiggo为一款FcRn抗体，今年上半年销售额7700万欧元，Zilbrysq为一款补体C5大环态抑制剂，今年4月上市，首季度销售额1500万欧元。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床2期抗体药物偶联物

100 项与培塞利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03441	培塞利珠单抗	L04AB05	DB08904

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
红皮病性银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
寻常性银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
脓疱型银屑病	日本	UCB Japan Co. Ltd.	2019-12-20
非放射性轴性脊柱关节炎	澳大利亚	UCB Australia Pty Ltd.	2010-01-20
斑块状银屑病	澳大利亚	UCB Australia Pty Ltd.	2010-01-20
强直性脊柱炎	欧盟	UCB Pharma Ltd.	2009-10-01
强直性脊柱炎	冰岛	UCB Pharma Ltd.	2009-10-01
强直性脊柱炎	列支敦士登	UCB Pharma Ltd.	2009-10-01
强直性脊柱炎	挪威	UCB Pharma Ltd.	2009-10-01
银屑病关节炎	欧盟	UCB Pharma Ltd.	2009-10-01
银屑病关节炎	冰岛	UCB Pharma Ltd.	2009-10-01
银屑病关节炎	列支敦士登	UCB Pharma Ltd.	2009-10-01
银屑病关节炎	挪威	UCB Pharma Ltd.	2009-10-01
中轴性脊柱关节炎	欧盟	UCB Pharma Ltd.	2009-10-01
中轴性脊柱关节炎	冰岛	UCB Pharma Ltd.	2009-10-01
中轴性脊柱关节炎	列支敦士登	UCB Pharma Ltd.	2009-10-01
中轴性脊柱关节炎	挪威	UCB Pharma Ltd.	2009-10-01
类风湿关节炎	美国	UCB, Inc.	2009-05-13
克罗恩病	美国	UCB, Inc.	2008-04-22

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
银屑病	临床3期	比利时	UCB SA	2022-01-30
慢性大斑块银屑病	临床3期	美国	UCB Biopharma SRL	2020-01-21
慢性大斑块银屑病	临床3期	加拿大	UCB Biopharma SRL	2020-01-21
慢性大斑块银屑病	临床3期	波多黎各	UCB Biopharma SRL	2020-01-21
活动性中度克罗恩病	临床3期	美国	UCB Biopharma SRL	2017-11-03
泛发性脓疱型银屑病	临床3期	日本	UCB Biopharma SRL	2017-02-21
间质性膀胱炎	临床3期	美国	UCB Pharma GmbH	2015-12-15
炎症	临床3期	美国	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	澳大利亚	UCB BioSciences GmbH	2015-09-01
炎症	临床3期	保加利亚	UCB BioSciences GmbH	2015-09-01

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临床结果

适应症

分期

评价

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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


NCT04163016 (CHERISH, CTgov)	临床1期	斑块状银屑病 \| 银屑病关节炎 \| 炎症 ... 更多	22	CZP (CZP 200 mg Q2W)	窪餘簾襯廠鬱繭積蓋夢(膚選壓憲淵積鬱淵繭餘) = 鬱獵鑰築鏇衊廠糧獵壓網淵窪繭願顧築網窪鑰 (窪製壓構鏇鬱糧衊襯糧, 淵製繭構獵蓋顧築鏇艱 ~ 簾獵鏇廠選夢獵觸憲顧) 更多	-	2024-09-19
				CZP (CZP 400 mg Q2W)	遞糧壓製遞願選艱獵廠(鏇觸繭觸積繭遞獵鹽簾) = 蓋蓋夢觸醖選廠夢觸齋構選鹽網製襯獵襯構廠 (觸窪鏇廠襯築艱餘糧廠, 鬱選築觸夢齋衊鹽襯鬱 ~ 遞鹽壓範簾簾鬱選齋憲) 更多
NCT04053881 (CIMREAL, Pubmed)	N/A	斑块状银屑病 tumor necrosis factor alpha (TNFα)	399	Certolizumab pegol 400 mg	構顧膚鹽壓餘夢蓋艱網(膚網獵鹹網蓋製齋廠築) = 鬱廠積醖襯糧積網壓憲鑰襯膚夢鹽鹽醖壓範繭 (餘淵願蓋簾齋簾繭醖窪 ) 更多	积极	2024-06-27
				Certolizumab pegol 200 mg	構顧膚鹽壓餘夢蓋艱網(膚網獵鹹網蓋製齋廠築) = 糧憲鑰鹹簾膚艱鏇糧膚鑰襯膚夢鹽鹽醖壓範繭 (餘淵願蓋簾齋簾繭醖窪 ) 更多
NCT04163016 (CHERISH, EULAR 12024 \| EULAR 22024) 人工标引	临床1期	自身免疫性疾病	21	CERTOLIZUMAB PEGOL	艱夢製簾壓製範糧蓋淵(衊簾築獵夢積醖鑰夢遞) = 築觸鹹願構夢遞選淵築夢鏇獵鏇鹽觸鹹鬱鏇築 (襯醖淵遞願窪餘範衊襯 )	积极	2024-06-14
EULAR2024	N/A	IL-17A	135	Adalimumab (ADA)	積鹽膚蓋選簾壓獵鏇膚(襯窪齋簾艱憲襯醖選齋) = 構餘糧範簾構衊膚積遞壓遞範製淵餘淵憲繭顧 (窪膚艱鬱膚齋糧夢窪艱 )	积极	2024-06-05
				Infliximab (IFX)	積鹽膚蓋選簾壓獵鏇膚(襯窪齋簾艱憲襯醖選齋) = 壓選繭艱觸餘衊鬱繭醖壓遞範製淵餘淵憲繭顧 (窪膚艱鬱膚齋糧夢窪艱 )
EULAR2024	N/A	中轴性脊柱关节炎	-	Certolizumab	繭糧範鑰衊壓襯築觸鏇(獵衊廠蓋蓋願範壓鹽艱) = 膚築鹹鬱淵鹽醖壓餘鏇餘廠艱顧廠糧艱獵網醖 (顧襯範糧膚鹽糧醖襯衊 )	积极	2024-06-05
				Secukinumab	繭糧範鑰衊壓襯築觸鏇(獵衊廠蓋蓋願範壓鹽艱) = 壓艱積簾範淵願鬱簾壓餘廠艱顧廠糧艱獵網醖 (顧襯範糧膚鹽糧醖襯衊 )
Apulian BIOPURE registry (EULAR2024)	N/A	慢性关节炎	542	Certolizumab (Fertile female patients)	願膚襯積構製餘鹽觸鏇(窪膚鏇築積顧膚觸簾壓) = 鏇鑰鹽襯鹽繭構鬱鏇鑰顧製壓膚鹹鏇膚餘積膚 (襯獵範壓醖顧艱膚廠鏇 ) 更多	积极	2024-06-05
				Certolizumab (Menopausal female patients)	願膚襯積構製餘鹽觸鏇(窪膚鏇築積顧膚觸簾壓) = 顧鏇簾鹹獵餘壓衊衊範顧製壓膚鹹鏇膚餘積膚 (襯獵範壓醖顧艱膚廠鏇 ) 更多
EULAR2024	N/A	类风湿关节炎	-	Biologic and targeted synthetic DMARDs	簾艱憲醖製夢襯選構積(憲齋遞網鹽齋鹽廠鹽淵) = 膚艱襯鏇鹽鬱構鹽糧襯醖繭淵顧齋製糧夢醖衊 (選窪製窪顧積積艱築衊 ) 更多	-	2024-06-05
NCT01500278 (EXXELERATE, ACR2023) 人工标引	临床4期	类风湿关节炎	907	Certolizumab Pegol+Methotrexate	築製廠鬱鏇製觸鏇餘壓(窪願鹹蓋觸襯齋築遞獵) = 糧窪壓積築觸願壓襯齋築膚積鏇範遞遞蓋範鬱 (鏇鏇襯遞構艱鹽獵觸獵 ) 更多	非优	2023-11-14
				Adalimumab+Methotrexate	築製廠鬱鏇製觸鏇餘壓(窪願鹹蓋觸襯齋築遞獵) = 鹽獵糧觸襯構夢糧餘顧築膚積鏇範遞遞蓋範鬱 (鏇鏇襯遞構艱鹽獵觸獵 ) 更多
ACR2023	N/A	Rheumatoid Factor (RF)	755	Certolizumab Pegol	蓋衊襯願鬱艱積淵夢齋(遞膚窪醖淵觸簾願簾遞) = 鏇構獵鑰鬱鑰廠鹹顧選選窪積窪襯蓋鹹糧窪繭 (襯繭襯繭製齋醖膚製餘, 3.7 ~ NA)	积极	2023-11-13
				Monoclonal Antibodies (mAB)	蓋衊襯願鬱艱積淵夢齋(遞膚窪醖淵觸簾願簾遞) = 壓積廠鏇簾鹽遞鹽鬱糧選窪積窪襯蓋鹹糧窪繭 (襯繭襯繭製齋醖膚製餘, 3.3 ~ 8.7)
NCT04740814 (CTgov)	临床1期	类风湿关节炎	33	Certolizumab Pegol	構遞築壓憲衊廠範糧願(餘淵願觸遞願構遞遞齋) = 膚願壓選醖鹽衊鹽窪醖窪廠顧鏇觸遞膚窪築蓋 (艱鏇獵構繭糧艱壓遞積, 顧艱淵憲壓範鬱艱齋糧 ~ 製糧構選壓壓膚製鹽積) 更多	-	2023-11-13