This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".

开始日期2019-09-19

申办/合作机构

University Hospital Of Essen

NCT02798107

/ WithdrawnN/A

Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study

Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.

开始日期2019-05-20

申办/合作机构

Boehringer Ingelheim GmbH

NCT03359889

/ CompletedN/A

Post Marketing Surveillance Program of Praxbind Use in India.

This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.

开始日期2018-12-26

申办/合作机构

Boehringer Ingelheim GmbH

100 项与依达赛珠单抗相关的临床结果

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100 项与依达赛珠单抗相关的转化医学

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100 项与依达赛珠单抗相关的专利（医药）

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569

项与依达赛珠单抗相关的文献（医药）

2025-03-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Anticoagulation reversal (vitamin K, prothrombin complex concentrates, idarucizumab, andexanet‐α, protamine)

Review

作者: Liakoni, Evangelia ; Bekka, Elias

Bleeding events are common in patients prescribed anticoagulants and can have devastating consequences. Several specific and nonspecific agents have been developed to reverse the effects of anticoagulant drugs or toxins. Vitamin K, as the oldest of these antidotes, specifically counteracts the effects of pharmaceuticals and rodenticides designed to deplete stores of vitamin K‐dependent factors. In cases of life‐threatening bleeding, the addition of prothrombin complex concentrates (PCCs) allows for the immediate replacement of coagulation factors. While the use of PCCs has been extended to the non‐specific reversal of the effects of newer direct oral anticoagulants, the specific agents idarucizumab, targeting dabigatran and andexanet‐α, binding factor Xa inhibitors, have recently been developed and are being preferentially recommended by most guidelines. However, despite having rapid effects on correcting coagulopathy, there is to date a lack of robust evidence establishing the clear superiority of direct oral anticoagulant‐specific reversal agents over PCCs in terms of haemostatic efficacy, safety or mortality. For andexanet‐α, a potential signal of increased thromboembolic risks, comparatively high costs and low availability might also limit its use, even though emerging evidence appears to bolster its role in intracranial haemorrhage. Protamine is the specific agent for the reversal of unfractionated heparin anticoagulation used mainly in cardiovascular surgery. It is much less effective for low molecular weight heparin fragments and is usually reserved for cases with life‐threatening bleeding.

2025-02-05·Zhurnal voprosy neirokhirurgii imeni N. N. Burdenko

Correction of the effect of direct oral and parenteral anticoagulants in hemorrhagic stroke

Review

作者: Sychev, A.A. ; Baranich, A.I. ; Savin, I.A. ; Kudrina, V.G. ; Kozlov, A.V.

Background. Hemorrhagic stroke is associated with high risk of adverse outcome and follows intake of anticoagulants and antiplatelet agents in 25% of cases. The latest clinical guidelines of the Neurocritical Care Society for correction (reversal) of the effect of anticoagulants and antiplatelet agents in hemorrhagic stroke were published in 2016. Material and methods. In accordance with PRISMA recommendations, we reviewed the PubMed, eLibrary and UpToDate databases to a depth of 5 years and selected 48 articles. Results and discussion. Direct oral anticoagulants are currently common. To reverse their effect, one can use specific antidotes (idarucizumab is recommended for dabigatran, andexanet alfa (not yet registered In Russia) for factor Xa inhibitors (rivaroxaban, apixaban)) and combination of prothrombin complex concentrate and tranexamic acid. Protamine sulfate is antidote for unfractionated and low molecular weight heparins. Protamine sulfate completely inactivates unfractionated heparin, but it is less effective against low molecular weight heparin. It is characterized by high probability of anaphylactic reactions, especially after repeated administrations. The effectiveness of andexanet alpha and activated factor VII for reversing the effect of low molecular weight heparin is being studied. Fondaparinux sodium is used for heparin-induced thrombocytopenia. Protamine sulfate is ineffective for reversing the effect of fondaparinux. One can use prothrombin complex concentrate and andexanet alpha, but their effectiveness is unclear. Ciraparantag is being studied in clinical trials. Apparently, ciraparantag is highly effective as an antidote for various anticoagulants. Conclusion. Early hemostatic therapy and reversal of anticoagulant effects in patients with hemorrhagic stroke significantly reduce the risk of adverse outcomes. This problem is being studied. Regular literature review with creation of updated clinical guidelines is needed.

2025-02-01·PHARMACOTHERAPY

Intravenous thrombolysis for patients with acute ischemic stroke while receiving a direct oral anticoagulant: A systematic review and meta‐analysis

Review

作者: Starr, Jessica A. ; Pinner, Nathan A. ; Roberts, Megan Z. ; Durham, Spencer H.

Abstract:

Recent guidelines for acute ischemic stroke (AIS) indicate administration of intravenous thrombolysis (IVT) in patients receiving direct oral anticoagulants (DOAC) is not firmly established and may be harmful unless certain potential parameters are met. This systematic review and meta‐analysis explores safety outcomes and other clinical parameters from the growing number of publications describing patients taking a DOAC who experience an AIS that is treated acutely with IVT alone. Embase, International Pharmaceutical Abstracts, and PubMed were searched up to January 9, 2024 for studies including adult patients taking a DOAC who experienced an AIS treated with IVT and did not undergo endovascular therapy (EVT), regardless of the use of an anticoagulation reversal agent. Primary safety outcomes evaluated included symptomatic intracranial hemorrhage (sICH), any intracranial hemorrhage, and in‐hospital mortality. A total of 873 patients from 78 studies, primarily case reports or case series of patients receiving dabigatran with or without idarucizumab reversal (n = 340), were included in the review. The rate of sICH during the index hospitalization was 3.3%. Seven high‐quality studies with low risk of bias included outcomes for patients on DOAC and comparator groups of either patients not taking an oral anticoagulant (no OAC) or patients taking a vitamin K antagonist (VKA) with INR primarily <1.7 at the time of AIS. No significant difference was observed in the incidence of sICH among patients receiving DOAC vs. no OAC (odds ratio [OR] 0.8, 95% confidence interval [CI]: 0.48–1.33) or among patients receiving DOAC vs. VKA (OR 1.02, 95% CI 0.59–1.75). Similar findings of no difference were observed for other safety outcomes. Findings from this study suggest that utilization of IVT as sole recanalization therapy for AIS may be safe in patients taking a DOAC; however, further studies are needed to elucidate specific parameters that differentiate timepoints and variables to ensure safe, optimal treatment.

项与依达赛珠单抗相关的新闻（医药）

2025-02-20

·医药速览

抗体药物飞速发展的40年

前言抗体药物是生物医药领域最具革命性的突破之一，凭借高特异性、低毒性和广泛的治疗潜力，已成为全球制药市场增长最快的细分领域。自1986年首个单克隆抗体获批以来，抗体技术历经鼠源、嵌合、人源化到全人源抗体的迭代，逐步解决了免疫原性和疗效问题。目前，抗体药物已覆盖癌症、自身免疫病、感染性疾病等多个领域，市场规模在2021年达到2173亿美元，年增长率约15%。然而，其发展仍面临靶点限制、胞内递送难题、生产工艺复杂等挑战。本文系统梳理抗体药物的发展脉络、作用机制及产业化趋势，以期为行业提供全景视角。 2 治疗性抗体的发展阶段抗体药物的发展可分为四个阶段：鼠源性抗体、嵌合抗体、人源化抗体和全人源抗体。早期鼠源抗体因免疫原性强，易引发人抗鼠抗体（HAMA）反应，临床应用受限。1990年代，嵌合抗体（如抗CD20抗体利妥昔单抗）通过替换人源Fc段减少免疫原性，成为首个成功商业化的治疗性抗体。随后，人源化技术通过仅保留鼠源互补决定区（CDR），进一步优化安全性，代表性药物如曲妥珠单抗。2010年后，全人源抗体（如阿达木单抗）通过噬菌体展示或转基因小鼠技术实现完全人源化，显著降低免疫原性并扩大适应症。目前，全人源抗体已成为主流，但技术壁垒仍高。例如，全人源抗体的亲和力优化和规模化生产仍需突破。此外，新型抗体（如纳米抗体、双抗）的涌现推动技术向更高维度发展。 3 治疗性抗体的作用机制现有抗体药物的常见MOA包括（i）配体-受体相互作用的破坏；（ii）通过抗体依赖性细胞毒性（ADCC）、补体依赖性细胞毒性（CDC）和抗体依赖性细胞吞噬（ADCP）清除靶细胞；（iii）双特异性抗体T细胞结合器；（iv）通过增强内化和降解来下调受体；（v）靶向给药。阻断配体-受体相互作用配体-受体相互作用是许多细胞事件信号转导的初始步骤，包括细胞增殖、粘附和迁移，其中一些与癌症进展有关。结合配体-受体界面两侧的抗体可以破坏结合，干扰信号转导，从而阻止疾病进展。例如，贝伐单抗（Avastin）是2004年开发并批准用于治疗结直肠癌的第一种抗血管生成抗体药物。贝伐单抗的信号阻断抑制血管生成信号，降低肿瘤细胞血供，导致肿瘤缩小。通过ADCC和CDC的细胞清除大部分单克隆抗体的治疗活性源于Fc受体结合区域的效应器功能，这些效应器功能包括ADCC、ADCP和CDC。对于可溶性配体，单克隆抗体结合形成免疫复合物，可被效应细胞消除；对于细胞表面受体，单克隆抗体结合的细胞可被效应细胞攻击，导致细胞破坏和死亡。FDA批准第一个CD20嵌合抗体利妥昔单抗用于治疗非霍奇金淋巴瘤。利妥昔单抗的效力主要来自抗体参与的效应器功能，包括CDC、ADCP和ADCC。双特异性抗体T细胞结合器在许多抗肿瘤效应中，细胞毒性T细胞起着至关重要的作用，然而，抗肿瘤T细胞反应受到癌细胞免疫逃逸机制的限制。以T细胞受体为靶点的单克隆抗体可以模拟抗原识别的效果，诱导特异性T细胞增殖，并释放细胞毒性因子，如IL-2和INF-γ。为了将T细胞导向肿瘤细胞，人们设计了双特异性T细胞接合器。这种双特异性分子一边结合靶肿瘤细胞上过表达的细胞表面抗原，另一边结合T细胞受体中的CD3。从而在肿瘤细胞和T细胞之间架起桥梁，激活T细胞破坏肿瘤细胞。第一个针对CD19和CD3的双特异性T细胞结合器，即blinatumomab，于2014年12月在美国被批准用于治疗急性淋巴细胞白血病（ALL）。通过增强内化和降解实现受体下调尽管人类IgG1可以招募免疫细胞来破坏肿瘤细胞，但是用西妥昔单抗（IgG1）或帕尼妥单抗（IgG2）靶向EGFR，单一疗法的应答率分别仅为11%和8%。对于抗EGFR和HER2，观察到通过抗体结合的非重叠表位协同下调受体酪氨酸激酶，从而更有效地阻断EGFR信号。这种方法可能代表了抗体疗法的一种新策略。靶向给药通过抗体增强靶向给药的方式包括抗体偶联药物（ADC）和抗体免疫脂质体药物（IML）。ADC药物的MOA包括四个步骤：抗体与靶抗原结合、抗原抗体复合物内化、细胞内药物释放，以及有效载荷发挥作用，包括破坏DNA和微管，以及中断DNA合成等。靶向给药的效率取决于抗原抗体复合物的内化和ADC的细胞内分解，这可能受到抗原内吞特性和抗原抗体结合特性的影响。与ADC的情况不同，ADC每个抗体只能携带几个药物分子，每个免疫脂质体封装超过10000个药物分子，允许使用效力较低的化疗药物。此外，与其他ADC相比，免疫脂质体可能具有额外的优势，因为它可以使用相同的靶向颗粒来封装用于治疗的毒性药物和用于肿瘤可视化的放射性同位素。 4 抗体偶联药物（ADC）抗体偶联药物是由靶向特异性抗原的单克隆抗体与小分子细胞毒性药物通过连接子链接而成,兼具传统小分子化疗的强大杀伤效应及抗体药物的肿瘤靶向性。ADCs于20世纪90年代中期首次进入临床试验以来，经过近30年的发展，已经成为一个非常成功的肿瘤学平台。2009年gemtuzumab ozogamicin（Mylotarg) 是FDA批准的第一个ADC药物。目前，全球已上市16款ADC药物。 2009年，卡利霉素、金盏花素和美登素类药物是用于ADC开发的主要细胞毒素。十年来，这些分子仍然被用作有效载荷进行优化，以获得更好的稳定性和亲水性。新的细胞毒性物质也被开发出来，如PBDs、杜卡霉素和喜树碱衍生物等。抗体工程在10年间也已经取得了相当大的进展，允许更多的位点特异性偶联，提高了ADC的均一性和稳定性。近年来，ADC在实体瘤和血液瘤中取得突破。例如，DS-8201（靶向HER2）通过可裂解连接子搭载拓扑异构酶抑制剂，显著延长乳腺癌患者生存期。然而，脱靶毒性、耐药性和生产工艺复杂性仍是主要挑战。 5 双特异性抗体单克隆抗体因其特异性靶向分子的能力，已成为癌症治疗中一种关键而有效的治疗方式。然而，由于肿瘤复杂的疾病发病机制，针对单一靶点的单克隆抗体往往不足以表现出足够的治疗效果。因此，针对多个靶点的双特异性抗体（bsAbs）应运而生，它的发展改变了肿瘤免疫治疗的领域。根据其功能机制，BsAb可分为4类：结合同一抗原的两个表位、细胞-细胞接合器、双功能调节剂和细胞治疗中的BsAb。 2014年，首个靶向CD19/CD3ε的双特异性T细胞接合器（BiTE）blinatumomab被FDA批准用于治疗急性淋巴细胞白血病（ALL）。自那时起，bsAbs掀起了一阵开发热潮。截至2020年底，有三种bsAbs（catumaxomab、blinatumomab和emicizumab）获得批准。尤其最近几年，3年中新增了11种bsAbs获得了监管机构的批准，其中9种被批准用于治疗癌症(amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) ，2种用于非肿瘤适应症(faricimab, ozoralizumab) 。 7 抗体融合蛋白抗体融合蛋白通过将功能蛋白（如细胞因子、受体）与抗体Fc段结合，延长半衰期并增强效应功能。抗体融合蛋白典型代表包括：依那西普（TNFR-Fc）通过中和炎症因子治疗类风湿关节炎；凝血因子Ⅸ-Fc融合蛋白将半衰期从18小时延长至100小时，减少血友病患者注射频率。此外，细胞因子与抗体或抗体片段的融合可能导致更具针对性的TAA，这可能会提高细胞因子的疗效、药代动力学和局部浓度，并防止全身毒性。该领域的发展重点在于优化融合构象与功能协同性。 8 小分子抗体药物 F（ab'）2，是一种分子量为110kDa的二价片段，由两个通过铰链区连接在一起的Fab片段组成。由于尺寸较小，它们比单克隆抗体具有更好的渗透性。NMPA批准了Metuximab-I131，一种放射性碘[131I]标记的抗CD147 F（ab'）2单抗，用于治疗肝癌。目目前，FDA没有批准癌症治疗的F（ab'）2药物。单链抗体由重链（VH）和轻链（VL）的可变区域组成，它们通过柔性肽接头连接在一起。单链抗体可在大肠杆菌中表达，在肿瘤中显示出良好的渗透性。目前，在癌症治疗的临床试验中，正在开发几种单价单链抗体融合蛋白，包括L19-IL-2、rM28、D2C7-IT（I期）和Vicinium（III期）。纳米抗体是在自然界中存在的一些奇特的小分子抗体，它们分子量比较小，可变区即是获得具有抗原结合能力的结构域。FDA和EMA批准的第一种VHH药物caplacizumab（Ablynx Inc），是一种用于治疗成人获得性血栓性血小板减少性紫癜的人源化抗VWF VHH。临床上正在研究各种VHH，以评估其用于不同目的的效果，包括癌症治疗。例如，目前正在评估抗EGFR VHH、抗HER2 VHH、抗VEGFR2 VHH、抗c-Met VHH、和抗CXCR7 VHH。两个VHH正在进行癌症治疗的I期临床试验，Ablynx的抗CXCR4 VHH（ALX-0651）和诺华的新型激动性四价抗DR5 VHH（TAS266）。 9 抗体药物的免疫原性抗药抗体(Anti-drug antibody, ADA)是抗体药物免疫原性评价的主要方式。ADA的形成可以分为与患者相关的因素和与药物相关的因素。患者相关因素包括： 1．遗传因素：病人ADA出现和病人当时的免疫状态，主要组织相容性和人类白细胞抗原等位基因的差异相关。 2．患者疾病状态：例如有无过往的微生物和病毒感染史；单克隆抗体的免疫原性可能与年龄有关，即儿童的蛋白质周转率与成人不同，这可能导致观察到的免疫原性不同；疾病相关因素也强烈影响免疫原性；先前接触过类似或相关的单克隆抗体也会影响免疫原性。 3. 给药方案：重复给药或间歇给药比一次性使用的单克隆抗体诱导免疫原性的可能性更高；如联合使用免疫抑制剂，ADA会降低；与药物相关的因素包括： 1.抗体源性：尽管为了降低免疫原性，先后开发了嵌合抗体，人源化抗体和全人源单抗，但是人源化改造，并没有完全消除ADA，即使人源化抗体的CDR区，依然有强的免疫原性，产生抗独特型抗体。 2.配方、容器系统、储存条件会影响产品的免疫原性。这些因素可能通过成分与治疗蛋白质和容器封闭系统的相互作用影响免疫原性，例如蛋白质构象的改变、作为免疫佐剂的杂质的提取、引起诸如聚集、微粒或脱酰胺等改变。 3.改变的糖基化模式可降低或增强分子的免疫原性，例如通过屏蔽蛋白质主干或通过Toll样受体触发先天免疫应答。 4. 非典型的糖基化模式，例如可能发生在全新的表达系统中，与通常使用的表达系统相比，可能引起免疫原性的改变。 5.其他有助于免疫原性的因素包括产生方法、途径、剂量和给药频率产生的杂质。 10 抗体药物的产业化趋势抗体药物的开发和发展是高度动态变化的，了解抗体药物的产业化趋势有助于我们发现和设计更具开发潜力的候选药物。基于截至2020年6月批准的89种抗体药物的信息，有82种（92%）是全长的单克隆抗体，有1个是全长IgG的双特异性抗体（emicizumab）。在剩下的六个中，一个是双特异性T细胞结合器（blinatumomab）；三种是抗原结合片段（Fab），包括abciximab, idarucizumab和anibizumab；一种是Fab’（certolizumab pegol）。大多数上市的抗体药物使用的重链亚型是IgG1，占到统计的抗体药物的72.4%，另外分别有12个使用了IgG2重链和IgG4重链。近年来，ADAs发生率较低的抗体得到了更多的批准。1998年获批的曲妥珠单抗成为第一个ADA发生率低于1%的抗体药物。在所有统计的89个抗体药物中，ADA的平均报告发生率为11.3 ± 8.0%；其范围从bezlotoxumab的0%到alemtuzumab的62%。抗体药物的产品形式包括西林瓶、预先填充的注射器或注射笔以及冻干粉。多年来，西林瓶一直是市场上抗体药物最常见的产品形式，占到了55.2%。在其余产品形式中，冻干粉的形式占到22.9%，预填充注射器或注射笔占到21.9%。抗体药物的给药途径包括皮下、静脉注射和其它如皮内、玻璃体内等。在这89种抗体药物中，约三分之二（66.2%）是静脉注射，另有27种（30.4%）是皮下注射。在剩下的三种药物中，分别是皮内（racotumomab）、肌肉内（palvizumab）和玻璃体内（ranibizumab）给药途径。82种全长抗体的半衰期从17小时（sacituzumab goitecan）到50天不等（ravulizumab），平均值为14.5天；大多数上市的抗体药物在15至25天之间被清除。制剂是生物药开发的一个重要方面，对稳定性、安全性、药理学以及给药途径都有重要影响。在89种抗体药物中，87种使用缓冲液，35种使用张力调节剂，60种使用稳定剂，79种使用表面活性剂。 11 小结抗体药物历经四十年发展，已成为现代医学的支柱之一。从单抗到ADC、双抗，技术创新不断拓展治疗边界；从静脉注射到长效制剂，患者依从性持续改善。未来，随着人工智能驱动的抗体设计、新型偶联技术及全球化产能布局的发展将推动抗体药物行业迈向黄金的新纪元。参考文献： 1. Emergingnew therapeutic antibody derivatives for cancer treatment. Signal TransductTarget Ther. 2022; 7: 39. 2. Antibody–Drug Conjugates: The Last Decade. Pharmaceuticals 2020, 13, 245 3. The Chemistry Behind ADCs. Pharmaceuticals (Basel). 2021 May; 14(5): 442. 4. Anticancer bispecific antibody R&Dadvances: a study focusing on research trend worldwide and in China. J HematolOncol. 2021; 14: 124. 5.Trends in industrialization of biotherapeutics: a survey of product characteristics of 89 antibody-based biotherapeutics. MAbs.2023 Jan-Dec;15(1):2191301. 6.Development of Bispecific Antibody for CancerImmunotherapy: Focus on T Cell Engaging Antibody. Immune Netw. 2022 Feb; 22(1): e4. 7. A pivotal decade for bispecific antibodies?. MAbs. 2024 Jan-Dec;16(1):2321635. 往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学 | 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普 | 医药前沿笔记 PROTAC技术 | 抗体药物 | 抗体药物偶联-ADC 核酸疫苗 | CAR技术 | 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送 ①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

抗体药物偶联物

2024-09-11

·BioSpace

Feinstein Institutes Research Suggests New Management Protocols for Patients Taking Oral Anticoagulants

MANHASSET, N.Y.--(BUSINESS WIRE)--Direct oral anticoagulants (DOACs) are commonly used medications that help prevent blood clots, which can be dangerous for those suffering from heart conditions or at risk of venous thromboembolism. However, these medications can also increase the likelihood of bleeding, especially during surgeries. Researchers at the Feinstein Institutes for Medical Research recently published in the Journal of the American Medical Association (JAMA) protocols to effectively manage the administration of DOACs and minimize bleeding and clotting risks – suggesting new conventions for patients pre- and post-surgery. Approximately 4 million patients in the United States are currently being treated with DOAC therapy. The review paper, titled “Perioperative Management of Patients Taking Direct Oral Anticoagulants,” analyzed how physicians should handle a patient’s blood thinner medicine depending on whether a procedure is surgical and to what degree of risk a procedure presents. The paper reviewed 99 articles on blood thinners and surgery to inform its evaluation. The authors concluded that doctors must assess the bleeding risk (low, medium, or high) of a planned surgery. Additionally, the research recommends that standardized management protocols – which do not require testing DOAC levels, heparin bridging, or short-acting anticoagulants – can be safely and effectively used for patients undergoing elective or non-urgent procedures. However, for patients on DOACs who require emergency, urgent, or semi-urgent surgery, using anticoagulant reversal agents may be appropriate if DOAC levels are elevated or unavailable. “When patients taking DOAC blood thinners undergo an optional or nonsurgical procedure, doctors can follow a simple standardized management plan where they won’t need to administer a blood test to check DOAC levels or use heparin, an alternate blood thinner,” said Alex C. Spyropoulos, MD , professor at Feinstein Institutes’ Institute of Health System Science . “Through this careful review, we determine that urgent or emergent procedures are another story and may need additional therapy and monitoring to prevent complications.” Patients who require urgent or emergency surgeries may need additional medications that quickly reverse the effects of DOACs if bleeding occurs during the procedure. One type of reversal agent (examples include andexanet-α for edoxaban, rivaroxaban , or apixaban and idarucizumab for dabigatran) can help with specific DOACs, while a more general reversal agent called prothrombin complex concentrate (PCC) can reverse the effects of any DOAC medication, albeit less effectively. “A leader in the field, Dr. Spyropoulos advances patient care through his research,” said Kevin J. Tracey, MD , president and CEO of the Feinstein Institutes and the Karches Family Distinguished Chair in Medical Research at Northwell Health. “His new insights into preventing life-threatening blood clots during elective procedures have the potential to benefit countless patients at Northwell Health and globally.” In addition to this JAMA article, and investigating a blood clot prevention treatment called thromboprophylaxis – particularly in relation to the treatment of hospitalized COVID-19 patients – Dr. Spyropoulos and his co-authors recently published an article in the Journal of Thrombosis and Haemostasis that determined hospitals’ incorporation of a user-friendly clinical decision support tool can also significantly improve the appropriate use of blood clot prevention strategies. About the Feinstein Institutes The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its six institutes of behavioral science, bioelectronic medicine, cancer, health system science, translational research, and molecular medicine. We make breakthroughs in health condition, including endometriosis, lupus, postpartum depression, schizophrenia, sepsis. We are the global scientific leader in bioelectronic medicine – an innovative field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit and follow us on LinkedIn . Contacts Matthew Libassi 631-793-5325 mlibassi@northwell.edu

2023-11-13

·SYNAPSE

Analysis on the Clinical Research Progress of Fab Fragment

The Fab fragment, also known as the antigen-binding fragment, is the region of an antibody that can bind with antigens. The Fab fragment consists of a complete light chain and the VH and CH1 structural domains (Fd segment) of the heavy chain, with a molecular weight of approximately 50,000. Both the light and heavy chains contain a constant region and a variable region, with disulfide bonds linking the two chains. As Fab possesses both an antigen-binding site and a part of the constant region, it not only has the same antibody-antigen affinity and excellent tissue penetration ability as a single-chain antibody (scFv), but also a more stable structure. Therefore, it plays a significant role in clinical diagnosis and treatment. Compared with the complete IgG, the Fab fragment lacks the Fc region and, although it can selectively bind to the antigen, it does not precipitate. Due to its low autoimmunogenicity, it can't be recognized by living immune cells, thereby significantly reducing the likelihood of hypersensitivity reactions and enhancing the safety of a product. Fab-class antibody fragments have the characteristics of low molecular weight, strong tissue distribution specificity, low immunogenicity, and manipulability through gene engineering, making Fab an essential member in the field of pharmaceutical research. Fab-class drugs are widely applied in prevention, diagnosis, and treatment fields. Fab Fragment Competitive LandscapeAccording to Patsnap Synapse, as of 8 Oct 2023, there are a total of 69 Fab fragment drugs worldwide, from 115 organizations, covering 35 targets, 110 indications, and conducting 918 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, targets, organizations, clinical trials, and clinical results related to this drug type. Approved Fab Fragment Medicinal: IdarucizumabIdarucizumab is a drug that falls under the category of Fab fragment, monoclonal antibody in the field of biomedicine. It is designed to target dabigatran, a medication used to prevent blood clots. The therapeutic areas in which Idarucizumab is used include hemic and lymphatic diseases, as well as other diseases. The drug is primarily indicated for the treatment of blood coagulation disorders and hemorrhage. Idarucizumab was developed by Boehringer Ingelheim GmbH, a pharmaceutical company. It has received approval for use in the highest phase globally, indicating that it has successfully completed clinical trials and met the necessary regulatory requirements. The first approval of Idarucizumab took place in the United States in October 2015. This signifies that it was the first country to grant regulatory approval for the drug. Additionally, Idarucizumab is classified as an orphan drug, which means it is intended to treat rare diseases or conditions that affect a small number of individuals. In summary, Idarucizumab is a Fab fragment, monoclonal antibody drug developed by Boehringer Ingelheim GmbH. It targets dabigatran and is used in the treatment of blood coagulation disorders and hemorrhage. The drug has received approval in global markets, with its first approval occurring in the United States in October 2015. Idarucizumab is classified as an orphan drug, indicating its intended use for rare diseases or conditions. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Approved Fab Fragment Medicinal: Certolizumab PegolCertolizumab Pegol is a drug that falls under the category of Fab fragment, Monoclonal antibody. It specifically targets TNF-α, which is a protein involved in the immune system response. The drug has been approved for use in various therapeutic areas, including Immune System Diseases, Congenital Disorders, Hemic and Lymphatic Diseases, Nervous System Diseases, Skin and Musculoskeletal Diseases, Infectious Diseases, and Digestive System Disorders. Certolizumab Pegol has been indicated for the treatment of several conditions, such as Erythrodermic psoriasis, Psoriasis vulgaris, Pustular psoriasis, Non-radiographic axial spondyloarthritis, Ankylosing Spondylitis, Plaque psoriasis, Arthritis (Psoriatic and Rheumatoid), Axial Spondyloarthritis, Crohn Disease, Psoriasis, Multiple Sclerosis, and Granulomatous Disease, Chronic. The drug was developed by UCB SA, an originator organization in the pharmaceutical industry. It has received approval in multiple countries, with its first approval granted in the United States in April 2008. Certolizumab Pegol has undergone priority review, indicating its potential significance in addressing unmet medical needs or providing a substantial improvement over existing treatments. As a Fab fragment, Monoclonal antibody targeting TNF-α, Certolizumab Pegol offers a promising therapeutic option for a wide range of diseases affecting various body systems. Its approval in multiple countries, including the United States, highlights its effectiveness and safety profile. The drug's diverse therapeutic areas indicate its potential to address multiple medical conditions, ranging from immune system disorders to digestive system disorders. Certolizumab Pegol's approval in China further expands its reach and potential patient population. The drug's highest phase being approved globally signifies its advanced stage of development and successful clinical trials. With its first approval dating back to 2008, Certolizumab Pegol has established a significant presence in the pharmaceutical market, providing healthcare professionals and patients with a valuable treatment option. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Overall, Certolizumab Pegol's approval, therapeutic areas, and target specificity make it a noteworthy drug in the field of biomedicine. Its originator organization, UCB SA, has contributed to the advancement of pharmaceutical research and development, bringing innovative therapies to patients worldwide.

100 项与依达赛珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10741	依达赛珠单抗	V03AB37	DB09264

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
出血	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2015-10-16

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
静脉血栓栓塞	临床3期	俄罗斯	Boehringer Ingelheim GmbH	2016-09-07

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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


ISTH2023	N/A	-	3,465	Idarucizumab	膚網獵鑰夢衊餘顧壓鹹(網簾鏇衊遞齋憲製醖醖) = 餘糧鏇窪餘鹽網夢醖齋壓廠積餘夢構顧積鏇鬱 (餘壓範艱繭蓋蓋製鹽鑰, 11.5 ~ 19.6) 更多	-	2023-06-24
ISTH2022	N/A	-	101	Idarucizumab	夢艱獵築築鹹繭繭積鹽(遞鏇鑰選積鹹鏇糧糧餘) = 選鑰鏇鬱膚構餘選醖製夢選網簾顧膚積簾鹹築 (遞壓製顧餘鹹憲範廠簾 )	-	2022-07-09
ISTH2022	N/A	-	46	Idarucizumab	網觸製壓淵鹹鑰窪鏇蓋(淵網蓋憲餘壓鬱廠餘顧) = 糧鹹遞憲獵壓願積蓋憲顧鹹醖鏇構築憲構簾衊 (齋顧窪繭築夢蓋憲選鑰 )	-	2022-07-09
ISTH2022	N/A	-	6	Idarucizumab	願餘選蓋鏇蓋網遞願鹽(餘構襯鏇餘蓋選繭廠觸) = 艱願構淵衊醖遞觸簾夢獵鬱積壓製繭構艱壓積 (淵壓製窪餘鹽積顧蓋衊 ) 更多	积极	2022-07-09
NCT03343704 (CTgov)	临床3期	出血	19	Idarucizumab (Group A - Patients With Uncontrolled or Life-threatening Bleeding)	醖構鹽網蓋醖顧積構窪(廠糧鹽襯觸顧鏇淵餘選) = 顧顧憲簾糧衊選製顧鑰鏇構鑰鑰遞鹹蓋衊鑰選 (網醖壓製醖鹽鹹醖齋夢, 襯醖蓋淵範蓋簾觸膚壓 ~ 鏇製壓積糧憲餘獵淵窪) 更多	-	2021-08-20
NCT03343704 (CTgov)	临床3期	出血	19	Idarucizumab (Group B - Patients Not Bleeding But Requiring Emergency Surgery or Invasive Procedure)	醖構鹽網蓋醖顧積構窪(廠糧鹽襯觸顧鏇淵餘選) = 醖網鹽鹽簾餘鑰憲顧選鏇構鑰鑰遞鹹蓋衊鑰選 (網醖壓製醖鹽鹹醖齋夢, 積鹽醖餘壓繭艱遞糧艱 ~ 廠遞壓膚淵製鑰積鹹鬱) 更多	-	2021-08-20
ISC2021	N/A	出血	-	Idarucizumab	鑰淵襯餘繭壓遞構襯鏇(遞醖顧壓鑰窪鏇網網觸) = 糧壓淵遞艱網鹹蓋憲艱襯膚選淵築衊窪蓋簾衊 (範網鑰蓋範顧壓築糧觸 )	-	2021-03-01
ISC2021	N/A	出血	-	Andexanet Alfa	鑰淵襯餘繭壓遞構襯鏇(遞醖顧壓鑰窪鏇網網觸) = 鬱鹽觸簾鑰壓觸築夢鏇襯膚選淵築衊窪蓋簾衊 (範網鑰蓋範顧壓築糧觸 )	-	2021-03-01
ESC2020	N/A	-	-	Idarucizumab	願願餘網網廠顧繭憲膚(網鏇繭廠顧壓觸膚積鬱) = 鹹齋願遞壓淵醖壓網鹽衊積蓋淵齋構獵製鬱鹹 (構鹹糧鑰鬱觸鏇膚鏇壓, 3.4 ~ 5.0) 更多	-	2020-08-28
ISTH2020	N/A	-	26	Praxbind 5g	糧艱憲鹽獵糧鑰顧壓壓(繭積糧繭夢憲衊鹹製觸) = 網衊網網遞築鹹獵獵製構憲顧範顧鹽選構壓範 (醖願鏇選窪鏇艱選憲醖 )	-	2020-07-12
ISTH2020	N/A	-	26	Praxbind 2.5g	糧艱憲鹽獵糧鑰顧壓壓(繭積糧繭夢憲衊鹹製觸) = 繭壓憲醖鏇醖糧夢鑰鏇構憲顧範顧鹽選構壓範 (醖願鏇選窪鏇艱選憲醖 )	-	2020-07-12
ISTH2020	N/A	-	7	Idarucizumab	夢廠衊選願製觸壓鏇窪(廠製壓遞衊廠範鬱廠齋) = 醖簾顧襯鑰醖製製觸膚餘願鹹餘製築齋窪選醖 (襯遞築鏇選製製觸鏇獵 )	-	2020-07-12
NCT02815670 (CTgov)	临床3期	出血 \| 静脉血栓栓塞	1	Idarucizumab	鏇鹹鹹艱製廠鏇製選構 = 艱鑰廠製醖壓獵壓餘積範選選鹽衊積壓鹽鏇襯 (獵餘壓鑰遞鬱憲繭構廠, 憲膚顧簾積蓋襯築繭積 ~ 鏇鬱繭鹹壓淵鏇膚獵蓋) 更多	-	2020-04-14