人血丙种球蛋白(Immunoglobulin(Baxalta Innovations GmbH))

概要

基本信息

药物类型

免疫球蛋白

别名

human normal immunoglobulin(Baxter )、Subcuvia

靶点-

作用机制-

治疗领域-

在研适应症-

非在研适应症-

原研机构

Baxalta Innovations GmbH

在研机构

Baxalta Innovations GmbH

非在研机构-

最高研发阶段批准上市

首次获批日期

德国 (2004-08-05)

最高研发阶段(中国)-

特殊审评-

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关联

42

项与人血丙种球蛋白相关的临床试验

ACTRN12623001336673

/ Not yet recruiting临床2期IIT

Comparing Use of B-cell depletion therapy to Immunoglobulin in Chronic inflammatory demyelinating polyneuropathy (CUBIC) clinical trial.

开始日期2024-08-05

申办/合作机构

Western Sydney Local Health District

PACTR202411838959146

/ RecruitingN/AIIT

Effect of Intravenous Immunoglobulin as Adjuvant Therapy for Septic Shock Patients Admitted to Alexandria University Pediatric Intensive Care Unit

开始日期2024-05-01

申办/合作机构-

CTRI/2023/08/056013

/ Not yet recruitingN/A

USE OF IV IMMUNOGLOBULIN MIXTURE IN THE TREATMENT OF BURN SEPSIS: A RANDOMIZED CONTROL TRIAL - NIL

开始日期2023-08-19

申办/合作机构

All India Institute of Medical Sciences

100 项与人血丙种球蛋白相关的临床结果

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100 项与人血丙种球蛋白相关的转化医学

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100 项与人血丙种球蛋白相关的专利（医药）

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252

项与人血丙种球蛋白相关的文献（医药）

2024-07-03·BRITISH POULTRY SCIENCE

Expression of genes related to ileal barrier function in heritage and modern broiler chickens

Article

作者: Proszkowiec-Weglarz, M. ; Schreier, L. L. ; Miska, K. B. ; Kpodo, K. R.

1. An experiment was conducted to determine differences in the expression of genes encoding intestinal barrier proteins between fast, medium and slow-growing chickens. Chicken breeds Athens Canadian Random Bred (ACRB), Longenecker's Heritage (LHR), RedBro, Hubbard H1 (HH1), Cobb500 and Ross708 were raised from hatch for 35 d.2. Ileal samples were collected at embryonic day E19 (-2 days post-hatch), hatch and d 7, 14, 21, 28 and 35 post-hatch to assess the expression of genes encoding tight junction proteins (claudins, CLDN; occludin, OCLN; zonula occludens, ZO; and junctional adhesion molecules, JAM), mucin (Muc2), immunoglobulin A (IgA), polymeric immunoglobulin receptor (pIgR) and fatty acid binding protein (FABP2).3. Expression of CLDN-1 was increased (p < 0.0001) in LHR compared to Cobb500 while CLDN-5 was increased (p < 0.0001) in ACRB, HH1, RedBro and Ross708 compared to LHR as well as in ACRB compared to Cob500. Occludin was upregulated (p = 0.01) in ACRB and LHR compared to Ross708 at d 14 post-hatch. Expression of ZO-1 was upregulated (p = 0.001) in LHR compared to Ross708, HH1 and Cobb500. Tight junction genes, except CLDN-4, JAM-2 and JAM-3 were downregulated (p < 0.0001) at hatch and d 7 post-hatch. Expression of Muc2 was increased (p < 0.0001) in LHR compared to RedBro and from -2 d to d 7 post-hatch.4. Immunoglobulin A was increased (p = 0.001) in LHR compared to Ross708 and HH1 at -2 d post-hatch and in LHR compared to ACRB, Cobb500 and Ross708 at hatch. In addition, IgA expression was increased in all breeds at d 14 post-hatch while pIgR was upregulated (p = 0.02) in Cobb500 and Ross708 compared to ACRB, HH1, LHR and RedBro at hatch.5. The gene expression patterns suggest that selection for growth may have not induced changes in junctional complexes and immune defence genes. However, the results confirmed that the expression of these genes is age dependent.

2024-07-01·American heart journal

Different dose aspirin plus immunoglobulin (DAPI) for prevention of coronary artery abnormalities in Kawasaki disease: Study protocol for a multi-center, prospective, randomized, open-label, blinded end-point, non-inferiority trial

Article

作者: Li, Wei ; Zhang, Li ; Wang, Yanfei ; Xie, Xiaofei ; Xia, Shuliang ; Hu, Lin ; Zhang, Xu ; Li, Jianbin ; Huang, Ping ; Wang, Zhouping ; Yuan, Jia ; Wu, Yujian ; Li, Ming ; Li, Fengxiang

BACKGROUND:

Kawasaki disease is a pediatric acute systemic vasculitis that specifically involves the coronary arteries. Timely initiation of immunoglobulin plus aspirin is necessary for diminishing the incidence of coronary artery abnormalities (CAAs). The optimal dose of aspirin, however, remains controversial. The trial aims to evaluate if low-dose aspirin is noninferior to moderate-dose in reducing the risk of CAAs during the initial treatment of Kawasaki disease.

METHODS:

This is a multi-center, prospective, randomized, open-label, blinded endpoint, noninferiority trial to be conducted in China. The planned study duration is from 2023 to 2026. Data will be analyzed according to intention-to-treat principles. Participants are children and adolescents under the age of 18 with Kawasaki disease, recruited from the inpatient units. A sample size of 1,346 participants will provide 80% power with a one-sided significance level of 0.025. Qualifying children will be randomized (1:1) to receive either intravenous immunoglobulin (2 g/kg) plus oral moderate-dose aspirin (30-50 mg·kg^-1·d^-1) until the patient is afebrile for at least 48 hours, or immunoglobulin plus low-dose aspirin (3-5 mg·kg^-1·d^-1) as initial treatment. The primary outcome will be the occurrence of CAAs at 8 weeks after immunoglobulin infusion. Independent blinded pediatric cardiologists will assess the primary endpoint using echocardiography.

CONCLUSIONS:

There is a shortage of consensus on the dose of aspirin therapy for Kawasaki disease due to the lack of evidence. The results of our randomized trial will provide more concrete evidence for the efficacy and adverse events of low- or moderate-dose aspirin in the acute phase of Kawasaki disease.

TRIAL REGISTRATION:

www.chictr.org.cn: ChiCTR2300072686.

2024-04-09·Blood advances

Immunoglobulin replacement vs prophylactic antibiotics for hypogammaglobulinemia secondary to hematological malignancy

Article

作者: Trotman, Judith ; Dendle, Claire ; McQuilten, Zoe K. ; Pepperell, Dominic ; Morrissey, C. Orla ; Pullon, Humphrey ; Waters, Neil ; Thao, Le Thi Phuong ; Keegan, Anastazia ; Wellard, Cameron ; Gilbertson, Michael ; van Tonder, Tina ; Weinkove, Robert ; Wood, Erica M. ; Weston, Helen ; Johnston, Anna ; Crispin, Philip ; Degelia, Amber ; Reynolds, John

Abstract:

Immunoglobulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared. In this randomized controlled feasibility trial conducted in 7 hospitals in Australia and New Zealand, we enrolled patients with secondary hypogammaglobulinemia with either a history of recurrent/severe infection or an immunoglobulin G level <4 g/L. Participants were randomized in a 1:2 ratio to immunoglobulin (0.4 g/kg per 4 weeks IV) or daily antibiotics (trimethoprim-sulfamethoxazole 160 mg/800 mg or, if contraindicated, 100 mg doxycycline) for 12 months. Participants allocated to antibiotics were allowed to crossover after grade ≥3 infections. The primary outcome was proportion of patients alive on the assigned treatment 12 months after randomization. Between August 2017 and April 2019, 63 patients were randomized: 42 to antibiotics and 21 to immunoglobulin. Proportion of participants alive on allocated treatment at 12 months was 76% in the immunoglobulin and 71% in the antibiotic arm (Fisher exact test P=.77; odds ratio, 0.78; 95% CI, 0.22-2.52). The lower quartile for time to first major infection (median, not reached) was 11.1 months for the immunoglobulin and 9.7 months for the antibiotic arm (log-rank test, P=.65). Three participants in the immunoglobulin and 2 in the antibiotic arm had grade ≥3 treatment-related adverse events. A similar proportion of participants remained on antibiotic prophylaxis at 12 months to those on immunoglobulin, with similar rates of major infections. Our findings support the feasibility of progressing to a phase 3 trial. Trial registration #ACTRN12616001723471.

1

项与人血丙种球蛋白相关的新闻（医药）

2025-01-31

·医药魔方

呋喹替尼2024年销售收入2.9亿美元，武田下一任首席执行官确定

1月30日，武田公布2024财年（2024年4月-2025年3月）前三季度业绩报告，总营收35282亿日元（约234.00亿美元，按2024年平均汇率100日元=0.66323美元计算，下同），同比增长4.5%（按固定汇率计算）。如果按自然年（2024年1月-2024年12月）计算，武田2024年总营收达到45790亿日元（约303.69美元）。从地域分布来看，美国市场的收入贡献最高，达到23517亿日元（约155.97亿美元）；其次是欧洲合并加拿大市场和日本市场，分别收入10409亿日元（约69.04亿美元）和4334亿日元（约28.74亿美元）。武田将其业务划分为胃肠病（GI）、罕见病、血浆衍生疗法（PDT）、肿瘤、疫苗和神经六大板块。武田2024年产品收入（亿美元）胃肠病（GI）业务在武田的整体业务收入中占比最高（29%），达到13195亿日元（约87.51亿美元）。α4β7单抗Entyvio（维得利珠单抗）是武田胃肠病业务的核心产品，已上市十年之久，其2024年收入为8807亿日元（约58.41亿美元），是目前炎症性肠病（IBD）领域最畅销的生物制剂。未来几年，Entyvio的商业预期并不乐观，一方面是这两年即将失去市场独占期，两款生物类似药（PB016和AVT16）已启动III期临床，另一方面是承受来自同领域产品的激烈竞争，而且新兴高潜力靶点已有药物进入后期开发阶段。目前，IBD已不算小众赛道，默沙东、艾伯维等跨国药企在该领域达成的多项交易吸引了众多企业入局。为应对Entyvio的专利悬崖问题，武田在2022年12月斥巨资收购了Nimbus Therapeutics的TYK2抑制剂zasocitinib（TAK-279）。该药物不仅对IBD有治疗潜力，在斑块状银屑病等自免疾病上也有客观的治疗前景。目前，zasocitinib正在开展多项III期临床，武田预计在2026财年提交其上市申请。此外，武田预计2026财年也可披露zasocitinib治疗溃疡性结肠炎和克罗恩病的IIb期研究数据。在罕见病领域，武田专注于在遗传性血管性水肿（HAE）领域寻找突破性疗法。已上市6年多的Takhzyro（拉那利尤单抗）是目前HAE领域唯一适用于2岁及以上人群的长期预防选择。在2024年，Takhzyro为武田创造了2102亿日元（约13.94亿美元）的收入。这款产品同样面临着不小的竞争威胁，例如目前处于III期临床阶段的基因编辑疗法NTLA-2002有可能实现HAE的功能性治愈。血浆衍生疗法（PDT）业务对武田的整体业务收入也有不小的贡献，总收入为10133亿日元（约67.21亿美元），其中Immunoglobulin（人免疫球蛋白皮下制剂）提供了7350亿日元（约48.75亿美元）的收入，是武田的第二大收入品种。未来，武田计划继续投资开发创新且具有差异化优势的免疫球蛋白产品。在肿瘤领域，武田自和黄医药引进的Fruzaqla（呋喹替尼）交出了不错的商业化成绩，在2024年为其带来了438亿日元（约2.9亿美元）的收入，超出武田原本的预期。Fruzaqla是结直肠癌患者的创新治疗选择，无论生物标志物状态如何，该药物作为后线治疗均可为转移性结直肠癌患者带来显著的生存获益。在神经领域，武田目前主攻注意缺陷多动障碍领域，凭借Vyvanse/Elvanse（利右苯丙胺）、Adderall XR（安非他明+右旋安非他明）和Intuniv（胍法辛）三款产品在该领域建立起了市场地位。其中，Vyvanse/Elvanse还是暴食症领域的唯一治疗选择。不过，这款产品已在2023年8月失去市场独占期，其销售额已经开始走入下坡路。在推进产品开发之余，武田也在寻找合适的标的丰富管线布局。在2024年，武田围绕神经和血液病领域达成了4笔大额交易，包括与AC Immune的22亿美元合作、以13.75亿美元获得亚盛医药的奥雷巴替尼全球权益、出手13亿美元引进一款血液病创新药以及投资12亿美元牵手达歌生物开发分子胶降解剂。除了公布业绩，武田还透露了一则人事变动消息，现任总裁、首席执行官兼代表董事Christophe Weber将在2026年6月退休，武田美国业务部现任总裁Julie Kim将接任其职务。推荐阅读赛诺菲2024年财报：自免销冠诞生，度普利尤单抗收入142亿美元罗氏2024年财报：眼科双抗Vabysmo大卖44亿美元，中国区收入近61亿美元强生2024年财报出炉！达雷妥尤单抗116亿美元，传奇CAR-T同比增长92.7% Copyright © 2025 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

财报临床3期生物类似药疫苗并购

100 项与人血丙种球蛋白相关的药物交易

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研发状态

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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


EHA2022	N/A	多发性骨髓瘤	2,445	IMMUNOGLOBULIN (Patients who received Ig)	壓範鬱襯襯膚鹽窪壓願(醖衊淵積鹹膚糧窪鑰鹹) = 觸範簾選壓壓選鑰鬱夢範餘糧衊鹽艱窪艱範構 (獵壓餘淵餘鹹簾襯鑰鬱 )	-	2022-05-12
				IMMUNOGLOBULIN (Patients who did not receive Ig)	壓範鬱襯襯膚鹽窪壓願(醖衊淵積鹹膚糧窪鑰鹹) = 淵窪餘製構鹹選壓積夢範餘糧衊鹽艱窪艱範構 (獵壓餘淵餘鹹簾襯鑰鬱 )
ASN2021	N/A	终末期肾脏病	42	Moderna vaccine	鏇夢壓觸製窪願襯鬱顧(憲糧鹹齋夢鹽繭衊獵簾) = 鏇鬱鑰構觸衊鏇餘艱獵鹹餘淵獵齋繭艱鹹蓋獵 (簾鬱鏇選選餘範鏇憲鹽 ) 更多	积极	2021-10-27
				Pfizer vaccine	鏇夢壓觸製窪願襯鬱顧(憲糧鹹齋夢鹽繭衊獵簾) = 願獵築製鹹選憲製網壓鹹餘淵獵齋繭艱鹹蓋獵 (簾鬱鏇選選餘範鏇憲鹽 ) 更多
ICD-9 code 323.9 (AAN2019)	N/A	桥本脑炎	-	Intravenous Immunoglobulin (IVIG)	醖窪鏇艱鹽選獵簾蓋憲(製窪積壓簾蓋築築顧觸) = 鑰鬱築淵獵鏇醖鹽鏇簾鑰夢壓願艱顧鹹鹽齋衊 (壓願鏇餘窪製蓋繭選壓 )	-	2019-04-09
				Plasma Exchange (PLEX)	醖窪鏇艱鹽選獵簾蓋憲(製窪積壓簾蓋築築顧觸) = 觸淵夢餘淵餘壓鹹壓窪鑰夢壓願艱顧鹹鹽齋衊 (壓願鏇餘窪製蓋繭選壓 )
P5.044 (AAN2016)	N/A	慢性炎症性脱髓鞘性多发性神经病 \| 多发性骨髓瘤	-	IVIG	鹹獵夢範窪觸觸選窪夢(觸積憲觸醖網顧鹹鹽艱) = 遞遞範襯觸壓鹽糧憲糧淵壓築鹹膚齋觸顧淵憲 (選鹽範獵餘鹹積遞積夢 ) 更多	-	2016-04-05
				Immunoglobulin	鹹獵夢範窪觸觸選窪夢(觸積憲觸醖網顧鹹鹽艱) = 蓋膚齋願簾膚襯網蓋願淵壓築鹹膚齋觸顧淵憲 (選鹽範獵餘鹹積遞積夢 ) 更多
NNINDS 1R01NS093653 (ANA2015)	N/A	小纤维神经病变 autoimmunity	30	IVIG 2 grams/kg/4 weeks	積壓遞鑰觸顧積糧憲餘(積鏇蓋繭襯築壓艱齋鬱) = 遞鏇鬱鑰鏇齋餘糧繭構醖蓋蓋窪醖鏇構糧糧膚 (鏇鏇築鏇壓憲糧顧願積, 2.5)	积极	2015-09-25
SP153 (ERA2015)	N/A	膜性肾小球肾炎 IgG \| IgM \| IgA	61	IMMUNOGLOBULIN (rich form LMN)	鬱壓淵顧鹽繭窪繭築獵(憲鏇顧築夢醖齋構廠糧) = 簾齋淵襯願鏇膚醖鬱齋網鹽繭醖鹽鑰繭製鬱願 (觸積範積壓積獵憲廠醖 )	不佳	2015-05-21
				IMMUNOGLOBULIN (poor form LMN)	鬱壓淵顧鹽繭窪繭築獵(製糧糧壓襯選壓顧鹹齋) = 獵窪製窪衊衊淵淵網淵廠膚窪夢繭網廠願艱繭 (觸築網夢範鹹蓋淵遞製 ) 更多