This research aims to investigate whether symptoms of chest pain or shortness of breath among the study population are arising due to a heart problem, particularly any reduction of blood flow to the heart muscle from blockages in the coronary blood vessels or inflammation of the heart using cardiac magnetic resonance imaging that measures the amount of blood flow during a stress state meant to simulate vigorous exercise. At present, doctors use standard magnetic resonance imaging pictures of blood flow patterns to treat heart disease. The investigators want to study if detailed blood flow measurements, in addition to the standard blood flow pattern, could diagnose heart disease more accurately and allow more doctors to understand the severity of heart disease. Early research has demonstrated that detailed blood flow measurements may be more accurate in diagnosing heart disease in some patients, but doctors need more information to know how to use these measurements.

开始日期2025-03-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

NCT05915728

/ Completed临床3期

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check blood pressure and heart rate
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

NCT05915702

/ Completed临床3期

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check blood pressure and heart rate
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

开始日期2023-07-24

申办/合作机构

Bayer AG

100 项与钆布醇相关的临床结果

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100 项与钆布醇相关的转化医学

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100 项与钆布醇相关的专利（医药）

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766

项与钆布醇相关的文献（医药）

2025-06-01·Radiological Physics and Technology

Development of estimation method for T1 and T2 values using the relaxivity of contrast agent and coagulant for a magnetic resonance imaging phantom

Article

作者: Yamamoto, Shohei ; Okada, Hiroki ; Komatsuzaki, Tetsuya ; Fuse, Hiraku ; Shimizu, Hatsune ; Miyakawa, Shin ; Yasue, Kenji ; Sasaki, Kota ; Takahashi, Masato ; Koori, Norikazu

The T₁ and T₂ values of magnetic resonance imaging phantoms used by researchers should be equivalent to those of the target tissue. However, this is difficult to achieve because of variations in the phantoms depending on the type and concentration of contrast agents and coagulants. The aim of this study was to elucidate the utility of a determination equation derived using the relaxivity of the contrast agent and coagulant. We prepared phantoms using 0.05-10 mmol L^-1 contrast agent (Gadovist^®; Bayer Yakuhin, Ltd., Osaka, Japan) and 0.1-5.0 wt% agar (agar, powder [010-15815]; Fujifilm Wako Pure Chemical Corporation, Osaka, Japan) and measured their T₁ and T₂ values. Determination equations for T₁ and T₂ values were derived using the relaxivity calculated from the T₁ and T₂ values of the contrast agent and coagulant. Subsequently, the determined values were compared with the measured values. The error rate of the determined T₁ and T₂ values were 7.66 ± 6.60% and 5.66 ± 4.05%, respectively, with correlation coefficients of 0.996 and 0.999. These results indicate that this method enables easy and highly accurate estimation of T₁ and T₂ values in MRI phantoms.

2025-05-01·NEUROLOGY INDIA

Gadolinium Deposition in the Rat Brain after Repeated Administration of the Liver-Specific Gadolinium-Based Contrast Agent Gadoxetic Acid

Article

作者: Zhu, Kai ; Xu, Yikai

Background::

Studies on gadolinium deposition have recently been reported.

Objective::

The objective of this study was to investigate whether there is an increased magnetic resonance signal intensity (SI) of the dentate nucleus (DCN) and quantification of gadolinium (Gd) brain concentrations by inductively coupled plasma-mass spectrometry (ICP-MS) test in rats who had undergone multiple administrations of gadoxetic acid and gadobutrol.

Materials and Methods::

Sprague–Dawley rats (24) were equally divided into three groups. Eight animals per group received 20 intravenous injections of gadoxetic acid (0.15 mmol/kg) and gadobutrol (0.6 mmol/kg) per injection. MRI was performed at 0, 5, and 20 weeks. Subsequently, all animals were euthanized and their brains were dissected for Gd quantification by ICP-MS.

Results::

ICP-MS revealed higher Gd content in cerebellum tissue after administration of gadoxetic acid compared to gadobutrol (P < 0.05). The mean Gd concentrations in the cerebellum were 0.48 nmol/g gadoxetic acid and 0.26 nmol/g gadobutrol after intravenous administration. No visually evident enhancement was found after administration of gadoxetic acid, gadobutrol, or saline at any time point. The DCN-to-pons SI ratios for gadoxetic acid and gadobutrol were not different from the saline control group (P > 0.05, saline vs. gadoxetic acid and saline vs. gadobutrol, respectively).

Conclusions::

Our results demonstrated that gadolinium concentrations in the cerebellum after intravenous gadoxetic acid administration were higher than for gadobutrol. Multiple administrations of gadoxetic acid disodium are not associated with increased SI in DCN.

2025-04-01·CLINICAL IMAGING

A review of gadolinium-based contrast agents in the setting of repeated MRI for high risk breast cancer screening

Review

作者: Reichman, Melissa ; Foshag, Kelcie ; Prince, Martin ; Tsiouris, Apostolos John

Women who are considered high risk for breast cancer are recommended to undergo supplemental breast cancer screening annually with MRI. There are primarily three safety concerns associated with gadolinium-based contrast agents which include allergic reactions, nephrogenic systemic fibrosis and gadolinium deposition. In this review, we discuss how these risks are affected by molecular structure, will specifically review the difference between the two commonly used agents, gadobutrol and gadoterate, and discuss the most recent FDA approved contrast agent on the market, gadopiclenol.

148

项与钆布醇相关的新闻（医药）

2025-04-17

·北陆药业

北陆药业2024年收入稳健增长净利润同比增幅120%！

近日，北陆药业（300016）发布《2024年年度报告》。2024年度，北陆药业继续稳健经营，实现营业收入98,355.45万元，同比增长10.42%；归属于上市公司股东的净利润1,365.17万元，同比增加119.02%，其中母公司净利润5,635.84万元，同比增加838.39%；归属于上市公司股东的扣除非经常性损益的净利润1,409.44万元，同比增加120.27%。为完成“二次创业”、实现“中国医药制造百强企业”的中长期目标，北陆药业在2024年继续落实“化药+中药”双轮驱动战略布局，主营业务依然专注于对比剂、降糖药以及中枢神经类中成药的生产与销售，同时通过收购承德天原药业进一步扩大中成药战略版图。稳健经营化药板块收入持续增长公司经过近两年的持续改革，逐步克服了化学药主打产品碘对比剂及降糖药管线受集采价格下降带来的巨大挑战，在首次中标执标及后续接续中标工作的推动下，实现了集采产品销量的增长。同时，公司也积极拥抱集采政策，将其作为公司研发、营销等工作的重要考量因素，加大对拟参与集中带量采购产品的研发及申报，力争抓住集采执标的契机，扩大产品的市场份额及品牌影响力。以上举措为公司提供稳定的利润支撑，确保良好的现金流状况，为公司的长期发展奠定坚实的基础。2024年度，公司对比剂产品实现销售收入58,804.95万元，同比增长9.87%，公司降糖类产品实现销售收入12,598.34万元，同比增长33.24%。原料药批文增加持续开拓海外市场原料药是公司化药板块的重要组成部分，北陆药业原料药产品涵盖钆类及碘类的原料药及辅料、中间体等，在保障制剂生产之余，各产品也积极开拓国内及国外市场。控股子公司海昌药业是国内为数不多的具有碘类对比剂原料药生产资质和产能的企业之一，其年产1000吨的碘造影剂项目设有碘海醇、碘克沙醇、碘普罗胺、碘佛醇、碘帕醇、碘比醇及碘美普尔等共计7个品种生产线。除了碘海醇，海昌药业已陆续获批碘克沙醇原料药、碘帕醇原料药等批件，为公司“原料药+制剂”一体化战略进一步夯实基础。同时海昌相关原料药产品也在积极申报海外注册。海昌药业在原料药方面的优势和产业布局的增强，有利于提升公司产品的多样性及公司的综合竞争力。深化中成药战略布局中药收入同比增长19.65%加大中成药板块布局是公司近几年的发展战略之一，公司通过并购中成药企业拓展中成药板块业务，逐步构建丰富的产品矩阵及核心竞争力，努力提升公司的市场份额及影响力，进一步增强公司在中成药领域的品牌形象。九味镇心颗粒是国内第一个通过国家食品药品监督管理总局批准治疗广泛性焦虑症的纯中药制剂，也是公司确立“抗焦虑中药第一品牌”的“黄金单品”。报告期内，公司收购天原药业80%的股权，其拥有的58个中药批文成为公司中成药板块重要组成部分。截至报告期末，天原药业生产、销售的品种共计20种，涵盖清热解毒类、感冒类、补肾强身类、脾胃肠消化类、活血止痛类、肝胆类，其中，核心产品金莲花颗粒系全国独家品种、国家医保乙类、OTC 乙类，系公司全力打造的另一“黄金单品”。公司金莲花颗粒、感冒清热颗粒等中药品种已中标多个地方集采，公司将借助集采执标，协同基层布局，提升金莲花颗粒等产品的市场份额及品牌影响力。报告期内，公司中药制剂实现销售收入16,844.68万元，同比增长19.65%。对比剂全线出海海外收入同比增长15.02%公司海外市场前期的拓展工作成效凸显。公司出口的产品主要为对比剂制剂及原料药，业务覆盖范围为南美洲、非洲、亚洲等市场，公司没有产品出口美国。报告期内，公司对比剂全线产品成功出海并实现营收大幅增长。原料药方面，不仅海昌药业的碘类原料药继续拓展海外市场，沧州分公司生产钆类原料药也逐步实现了国际化。随着欧盟EU GMP认证和巴西ANVISA GMP合规认证的完成，公司对比剂产品的国际化有望进一步提速。九味镇心颗粒在香港和泰国的注册工作继续按计划推进，为出口东南亚等地创造条件。报告期内，公司实现海外营业收入13,216.14万元，同比增长15.02%。储备产品丰富产品梯队建设成型经过2年多的研发投入和收购工作，公司的产品矩阵相对丰富，管线也实现了多元化。报告期内，公司获批钆特酸葡胺制剂及原料药、盐酸帕罗西汀肠溶缓释片、西甲硅油乳剂、复方聚乙二醇电解质散（Ⅲ）、钆布醇注射液新增规格的注册证书，完成了钆喷酸葡胺注射液、钆贝葡胺注射液一致性评价。研发团队不断提升研发效率，为扩大公司在相关领域的战略布局积极储备具有市场竞争潜力的品种。截至目前，公司审评中的项目12项，研发立项项目23项，共计35项。通过并购，公司中药领域批文数量达到59个，其中医保品种45个、基药品种18个、OTC品种41个。九味镇心颗粒、金莲花颗粒、五子衍宗丸、连翘败毒丸、参苓白术丸、消栓通络片、利肝隆片等21个品种在产在销，其余品种皆作为储备品种，等待适当时机开发上市。2025年，公司管理层将在董事会的带领下继续落实各项发展目标。包括但不限于各部门统筹协作，全面落实公司年度目标；加强各生产基地建设及管理，全面提升公司产能；继续推进天原药业的整合与赋能工作，提升中成药业务盈利水平；继续深化营销体系改革，强化营销管理中心职能，狠抓关键政策和重点项目的落地；坚持创新驱动，培养核心团队，提升研发能效；加速公司国际化进程，提升海外市场营收贡献；继续加强内控管理，有效控制风险。关于北陆药业年报更多信息可登录巨潮资讯网www.cninfo.com.cn查询。往期推荐01 【喜报】北陆药业碘海醇注射液欧盟获批上市02北陆药业控股子公司海昌药业碘帕醇化学原料药获批上市03 控股子公司海昌药业碘克沙醇原料药取得韩国注册证书识别二维码关注我们

财报带量采购并购申请上市基因疗法

2025-03-23

·信狐药迅

江苏柯菲平改良新醋酸沃诺拉赞注射液提交上市申请|新受理（3.17-3.23）

本周药品注册受理数据，分门别类呈现，一目了然。(3.17-3.23）新药上市申请药品名称企业注册分类受理号醋酸沃诺拉赞注射液江苏柯菲平医药股份有限公司2.1;2.2;2.4CXHS2500023瑞加诺生注射液南京瑞克卫生物医药有限公司2.4CXHS2500024 新药临床申请药品名称企业注册分类受理号ICP-248片北京诺诚健华医药科技有限公司1CXHL2500308ICP-248片北京诺诚健华医药科技有限公司1CXHL2500307NH104片江苏恩华药业股份有限公司1CXHL2500312NH104片江苏恩华药业股份有限公司1CXHL2500311AP303片礼邦药业(上海)有限公司1CXHL2500306AP303片礼邦药业(上海)有限公司1CXHL2500305AP303片礼邦药业(上海)有限公司1CXHL2500304AP303片礼邦药业(上海)有限公司1CXHL2500303AP303片礼邦药业(上海)有限公司1CXHL2500302苹果酸法米替尼胶囊江苏恒瑞医药股份有限公司1CXHL2500298RFUS-949片宜昌人福药业有限责任公司1CXHL2500297RFUS-949片宜昌人福药业有限责任公司1CXHL2500296GST-HG131片福建广生中霖生物科技有限公司1CXHL2500295GST-HG131片福建广生中霖生物科技有限公司1CXHL2500294奈瑞可韦片福建广生中霖生物科技有限公司1CXHL2500293奈瑞可韦片福建广生中霖生物科技有限公司1CXHL2500292TP1001 片生元泽通(上海)医药有限公司1CXHL2500300TP1001 片生元泽通(上海)医药有限公司1CXHL2500299布瑞哌唑口溶膜上海现代制药股份有限公司2.2CXHL2500310布瑞哌唑口溶膜上海现代制药股份有限公司2.2CXHL2500309NS1009新领医药(中山)有限公司2.2CXHL2500301CMCY2501片杭州中美华东制药有限公司2.4CXHL2500314ZHCX002九华华源药业股份有限公司2.4CXHL2500313吸附组分无细胞百白破(减剂量)联合疫苗中国医学科学院医学生物学研究所2.5CXSL2500229吸附组分无细胞百白破(减剂量)联合疫苗中国医学科学院医学生物学研究所2.5CXSL2500228流感病毒裂解疫苗(BK-01佐剂)长春百克生物科技股份公司3.2CXSL2500240流感病毒裂解疫苗(BK-01佐剂)长春百克生物科技股份公司3.2CXSL2500239GenSci134注射液长春金赛药业有限责任公司1CXSL2500238GenSci134注射液长春金赛药业有限责任公司1CXSL2500237BT02单克隆抗体注射液上海柏全生物科技有限公司1CXSL2500236VPD/FC01002 注射液微能生命科技集团有限公司1CXSL2500234SSS55注射液沈阳三生制药有限责任公司1CXSL2500235GB18注射液深圳科兴药业有限公司1CXSL2500226IBI363信达生物制药(苏州)有限公司1CXSL2500233IBI363信达生物制药(苏州)有限公司1CXSL2500232注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2500230阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500231 仿制药申请药品名称企业注册分类受理号秋水仙碱片一加药业(湖北)有限公司3CYHS2501148重酒石酸去甲肾上腺素注射液上海炫鑫医药科技有限公司3CYHS2501147乙酰唑胺片上海理想制药有限公司3CYHS2501142碘[131I]化钠口服溶液成都欣科医药有限公司3CYHS2501145呋塞米注射液华夏生生药业(北京)有限公司3CYHS2501124阿仑膦酸钠口服溶液黑龙江中桂制药有限公司3CYHS2501120福多司坦片湖北远大永晟药业有限公司3CYHS2501117盐酸溴己新注射液多多药业有限公司3CYHS2501114维生素B12注射液海南全星制药有限公司3CYHS2501128盐酸甲氧氯普胺注射液湖北天圣药业有限公司3CYHS2501127碘[131I]化钠口服溶液成都纽瑞特医疗科技股份有限公司3CYHS2501125盐酸布比卡因注射液河南普瑞药业有限公司3CYHS2501116盐酸布比卡因注射液河南普瑞药业有限公司3CYHS2501115盐酸溴己新口服溶液江苏欧歌制药有限公司3CYHS2501110间苯三酚口崩片四川海梦智森生物制药有限公司3CYHS2501105左羟丙哌嗪口服溶液江苏润恒制药有限公司3CYHS2501104加替沙星滴眼液合肥诺瑞特制药有限公司3CYHS2501102维生素B6注射液上海禾丰制药有限公司3CYHS2501112酒石酸阿福特罗吸入溶液正大天晴药业集团股份有限公司3CYHS2501111注射用氢化可的松琥珀酸钠河南利华制药有限公司3CYHS2501100注射用氢化可的松琥珀酸钠河南利华制药有限公司3CYHS2501099盐酸普罗帕酮注射液安徽长江药业有限公司3CYHS2501097硝普钠注射液成都欣捷高新技术开发股份有限公司3CYHS2501096硝普钠注射液成都欣捷高新技术开发股份有限公司3CYHS2501095注射用盐酸多西环素海南倍特药业有限公司3CYHS2501092盐酸拉贝洛尔注射液九华华源药业(桂林)有限公司3CYHS2501090盐酸拉贝洛尔注射液九华华源药业(桂林)有限公司3CYHS2501089盐酸利多卡因注射液河南普瑞药业有限公司3CYHS2501088盐酸利多卡因注射液河南普瑞药业有限公司3CYHS2501087双氯芬酸二乙胺乳胶剂海南紫程众投生物科技有限公司4CYHS2501153双氯芬酸二乙胺乳胶剂海南紫程众投生物科技有限公司4CYHS2501152来特莫韦注射液安徽省先锋制药有限公司4CYHS2501151枸橼酸西地那非口腔崩解片西施兰(南阳)药业股份有限公司4CYHS2501150甲磺酸酚妥拉明注射液成都倍特药业股份有限公司4CYHS2501149盐酸西替利嗪滴剂江苏联环药业股份有限公司4CYHS2501144地夸磷索钠滴眼液杭州民生药物研究院有限公司4CYHS2501143阿奇霉素片辰欣药业股份有限公司4CYHS2501141莫匹罗星软膏湖北午时药业股份有限公司4CYHS2501140利多卡因凝胶贴膏湖南华纳大药厂股份有限公司4CYHS2501139莫匹罗星软膏湖北午时药业股份有限公司4CYHS2501138莫匹罗星软膏湖北午时药业股份有限公司4CYHS2501137碘普罗胺注射液重庆药友制药有限责任公司4CYHS2501136碘普罗胺注射液重庆药友制药有限责任公司4CYHS2501135盐酸贝尼地平片福建东瑞制药有限公司4CYHS2501134盐酸贝尼地平片福建东瑞制药有限公司4CYHS2501133氧榆林市北方化工有限公司4CYHS2501132瑞舒伐他汀依折麦布片(Ⅰ)北京伟林恒昌医药科技有限公司4CYHS2501131卡格列净片江苏华鑫制药有限公司4CYHS2501130卡格列净片江苏华鑫制药有限公司4CYHS2501129培哚普利氨氯地平片(I)南京海纳制药有限公司4CYHS2501146贝美前列素滴眼液海南斯达制药有限公司4CYHS2501123氧(气态)陕西省汉中市汽车运输集团有限公司乙炔气厂4CYHS2501122骨化三醇软胶囊珠海健福制药有限公司4CYHS2501121洛索洛芬钠贴剂湖南华纳大药厂股份有限公司4CYHS2501119洛索洛芬钠贴剂湖南华纳大药厂股份有限公司4CYHS2501118布地奈德肠溶胶囊石药集团中诺药业(石家庄)有限公司4CYHS2501113氧(气态)镇安县康欣气体有限公司4CYHS2501126富马酸伏诺拉生片山西宝泰药业有限责任公司4CYHS2501109富马酸伏诺拉生片山西宝泰药业有限责任公司4CYHS2501108碳酸司维拉姆片仁合益康集团有限公司4CYHS2501107盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2501106黄体酮软胶囊苏州朗科生物技术股份有限公司4CYHS2501103硫酸氨基葡萄糖胶囊瀚玛斯(山西)医药科技有限公司4CYHS2501098艾拉莫德片安徽艾立德制药有限公司4CYHS2501094诺西那生钠注射液成都国为生物医药有限公司4CYHS2501093钆布醇注射液石家庄四药有限公司4CYHS2501091盐酸托莫西汀口服溶液山东新时代药业有限公司4CYHS2501101吡美莫司乳膏江苏盈科生物制药有限公司4CYHS2501086流感病毒裂解疫苗成大生物(本溪)有限公司3.3CXSS2500037酮洛芬凝胶贴膏北京阳光诺和药物研究股份有限公司3CYHL2500064艾拉戈克钠片东莞松山湖美健生物技术有限公司3CYHL2500063艾拉戈克钠片东莞松山湖美健生物技术有限公司3CYHL2500062 进口申请药品名称企业注册分类受理号利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500036利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500035利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500034利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500033利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500032利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500031利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500030利妥昔单抗注射液Roche Pharma(Schweiz)AG2.2JXSS2500029度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500028度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500027阿帕他胺片Aizant Drug Research Solutions Private Limited.5.2JYHS2500015MK-1084片Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2500051MK-1084片Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2500050VSA001注射液Arrowhead Pharmaceuticals, Inc.1JXHL2500048[225Ac]Ac-PSMA-617注射液Novartis Pharma AG1JXHL2500047地非法林注射液Vifor Fresenius Medical Care Renal Pharma Ltd.2.4JXHL2500049用于制备放射性药物镓(68Ga)gozetotide注射液的药盒Novartis Europharm Limited5.1JXHL2500046 中药相关申请药品名称企业注册分类受理号天苓止眩片湖南中医药大学1.1CXZL2500019松龄血脉康胶囊成都康弘制药有限公司2.3CXZL2500018夏枯草口服液江西和盈药业有限公司4CYZS2500004 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗申请上市

2025-03-19

·米内网

【关注】石四药入局亿级造影剂

精彩内容日前，CDE官网显示，石家庄四药的钆布醇注射液以仿制4类报产在审。米内网数据显示，钆布醇注射液在2023年中国公立医疗机构终端销售额近2亿元，2024年上半年同比增长13.32%。钆布醇注射液适用于成人及全年龄段儿童（包括足月新生儿），可用在全身各部位（包括颅脑和脊髓）病变的磁共振增强检查，其中全身各部位的动态磁共振血管造影（DCE-MRA）和动态磁共振增强检查（DCE-MRI）更具优势。近年中国公立医疗机构终端钆布醇注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局钆布醇注射液在近年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端快速增长，2023年销售额近2亿元，2024年上半年同比增长13.32%。米内网数据显示，钆布醇注射液有7家企业拥有生产批文，海南倍特药业、扬子江广州海瑞药业、江苏恒瑞医药等6家企业过评，海南葫芦娃药业集团、山东新时代药业、石家庄四药等6家企业以仿制4类报产在审。目前，石四药在造影剂领域暂无生产批文，仅钆布醇注射液报产在审，有望迎来公司首款造影剂产品。今年以来，石四药已有18款产品报产在审，涵盖高血压用药、全身用抗病毒药、咳嗽和感冒用药、眼科用药等多个治疗亚类。资料来源：CDE官网、米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

专利侵权

100 项与钆布醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07420	钆布醇	V08CA09	DB06703

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
冠心病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2019-07-12
主动脉疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2016-04-27
乳腺疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2014-12-29
中枢神经系统血管畸形	美国	Bayer HealthCare Pharmaceuticals, Inc.	2011-03-14
脑血管疾病	美国	Bayer HealthCare Pharmaceuticals, Inc.	2011-03-14
造影剂	澳大利亚	Bayer Australia Ltd.	1998-12-02

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
颈动脉狭窄	临床3期	美国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	中国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	阿根廷	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	澳大利亚	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	奥地利	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	捷克	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	法国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	德国	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	意大利	Bayer AG	2011-05-12
颈动脉狭窄	临床3期	波兰	Bayer AG	2011-05-12

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	临床4期	-	141	Reduced Dose Gadobutrol	齋膚齋繭觸艱淵艱願襯(艱壓壓選顧鑰齋獵範齋) = 窪糧醖鏇顧艱醖簾繭壓襯鹹觸艱顧衊觸鹹艱憲 (顧艱鹽壓構築壓齋鹽鏇 ) 更多	积极	2021-06-16
NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	临床4期	-	141	Standard Dose Gadoterate	齋膚齋繭觸艱淵艱願襯(艱壓壓選顧鑰齋獵範齋) = 淵鏇衊廠築膚顧範簾鏇襯鹹觸艱顧衊觸鹹艱憲 (顧艱鹽壓構築壓齋鹽鏇 ) 更多	积极	2021-06-16
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	繭簾蓋選蓋齋網簾構鏇(簾壓憲廠觸膚夢鏇夢餘) = 廠憲構鹹窪選糧憲窪範鹽觸淵鏇網窪醖淵願窪 (鏇衊廠繭糧構廠襯廠鹽, 0.252) 更多	-	2021-04-28
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	繭簾蓋選蓋齋網簾構鏇(簾壓憲廠觸膚夢鏇夢餘) = 製衊齋淵鹹壓築顧窪憲鹽觸淵鏇網窪醖淵願窪 (鏇衊廠繭糧構廠襯廠鹽, 0.201) 更多	-	2021-04-28
NCT03404648 (CTgov)	临床3期	晚期前列腺癌 \| 前列腺腺癌	19	PET/MR scanner+C-11 choline PET tracer+Gadobutrol	襯積窪鹹選構繭襯鹽簾(顧鏇遞願願遞鑰壓醖艱) = 淵醖蓋範鏇窪繭鹽糧窪鏇糧願艱範蓋鑰範艱鹽 (網鏇憲鬱鹽積網築鏇餘, 1.8) 更多	-	2021-02-08
NCT01890421 (GadaCAD 1, CTgov)	临床3期	冠心病	426	Gadovist	淵糧鹹窪願衊積網範艱 = 廠餘夢醖製膚簾繭艱窪獵網壓簾壓衊廠蓋衊憲 (範淵觸觸憲遞糧製鑰鑰, 願鹹鬱簾膚鬱遞築願醖 ~ 網鹽齋願膚製膚積齋襯) 更多	-	2018-05-16
NCT01890434 (GadaCAD 2, CTgov)	临床3期	冠心病	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	衊遞鏇醖鹹選衊鬱憲鏇 = 醖衊願範淵鏇淵齋願廠繭構壓顧鹹獵壓網遞願 (觸糧憲襯淵窪齋鏇鬱願, 醖艱簾夢齋襯製壓淵範 ~ 壓鬱製衊觸膚憲鬱壓壓) 更多	-	2018-05-16
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) 人工标引	N/A	造影剂	23,708	gadobutrol	積製醖艱願襯製鹹顧糧(簾願窪鬱蓋壓鬱願襯鹽) = 觸鏇夢鹹範廠獵齋製壓淵願鏇壓糧齋齋獵鬱遞 (淵鑰鏇鹹鏇遞選窪選醖 ) 更多	积极	2017-01-01
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) 人工标引	临床3期	肿瘤	906	Gadobutrol	衊選襯衊膚窪壓壓築觸(遞蓋範鏇襯淵鑰糧範製) = the detection rate of malignant disease extent per patient, ranged from 80% to 89% for CE-BMRI and was significantly superior to unenhanced breast MRI alone (37%-73%) and to mammography alone (68%-73%) for all readers in both trials. 壓觸壓襯築顧範構鹹顧 (壓夢醖簾淵淵範壓淵膚 )	积极	2016-07-01
NCT01344460 (GRAMS, Biospace) 人工标引	临床3期	血管疾病	292	Gadobutrol	壓窪淵獵構醖選構鑰餘(鹹壓構窪壓獵獵膚窪膚) = 網選遞鹹獵製網糧糧夢鏇廠廠醖繭獵鬱淵願鏇 (窪鬱膚範憲鹽淵襯獵網 ) 更多	积极	2016-04-29
NCT01490294 (CTgov)	临床2期	心血管疾病	232	Gadovist (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))	壓廠鑰壓願糧製廠淵築 = 餘鹽醖醖簾蓋顧淵鹹膚衊願鹽淵憲積膚鏇齋壓 (鬱蓋鬱簾選構餘襯窪齋, 蓋艱廠蓋襯製蓋構壓夢 ~ 網艱糧鬱鬱鏇壓築獵繭) 更多	-	2012-06-28
NCT01490294 (CTgov)	临床2期	心血管疾病	232	Gadovist (Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))	壓廠鑰壓願糧製廠淵築 = 糧齋艱鹹遞鏇窪蓋醖獵衊願鹽淵憲積膚鏇齋壓 (鬱蓋鬱簾選構餘襯窪齋, 鬱鹽鑰鬱鹹範範鹽網齋 ~ 鹽觸願願醖艱遞膚糧顧) 更多	-	2012-06-28