更新于：2024-11-04

Gadobutrol

钆布醇

更新于：2024-11-04

概要

概要

基本信息

药物类型

造影剂、小分子化药

别名

Gadobutrol (JAN/USAN/INN)、gadolinium(III) 2,2',2''-(10-((2R,3S )-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl)triacetate、Gadovist 1.0

+ [11]

靶点-

作用机制

磁共振成像增强剂

治疗领域

神经系统疾病心血管疾病遗传病与畸形+ [2]

在研适应症

冠心病主动脉疾病乳腺疾病+ [3]

非在研适应症

血脑屏障缺陷脑转移瘤乳腺癌+ [5]

原研机构

Bayer AG

在研机构

Bayer HealthCare Pharmaceuticals, Inc.Bayer Australia Ltd.

Bayer AG

非在研机构

拜耳医药保健有限公司Bayer Vital GmbHBayer Schering Pharma AG

最高研发阶段批准上市

首次获批日期

澳大利亚 (1998-12-02),

造影剂

最高研发阶段(中国)无进展

特殊审评-

登录后查看时间轴

结构

分子式C18H31GdN4O9

InChIKeyZPDFIIGFYAHNSK-ZCTZICQLSA-K

CAS号770691-21-9

关联

项与钆布醇相关的临床试验

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

NCT04910425 / Not yet recruiting临床2期IIT

Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer

This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.

开始日期2023-06-17

申办/合作机构

Northwestern University

[+1]

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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755

项与钆布醇相关的文献（医药）

2024-10-24·JOURNAL OF MEDICINAL CHEMISTRY

Construction of New MRI Contrast Agents for Spatiotemporal Visualization of Nitric Oxide in Ischemia/Reperfusion Organs

Article

作者: Xu, Anning ; Yan, Zhengsheng ; Huang, Zhangjian ; Sun, Yuze ; Zhang, Libang ; Yin, Zhiqi ; Yuan, Xun ; Gao, Zonglu ; Zhang, Yihua ; Wang, Lin ; Jing, Mei ; Zhang, Jian ; Wu, Jianbing

Noninvasive and real-time nitric oxide (NO) visualization in vivo is still a challenge. Herein, we constructed a series of NO-responsive magnetic resonance imaging (MRI) contrast agents Gd1b-e by modifying Gd-DO3A using a bis-pyridyl-ethylamine side chain as a signal-amplifying moiety and o-phenylenediamine as a NO-responsive linker. It was found that Gd1b, d, and e can form macromolecular ternary complexes (Gd-Zn²⁺-HSA) with high longitudinal relaxivity (r₁) (12.2-16.2 mM^-1 s^-1). Once reacting with NO, the o-phenylenediamine linker was hydrolyzed to produce a small molecular Gd complex with sharply decreased r₁ (4.7-6.3 mM^-1 s^-1). Among them, Gd1d with a desirable pharmacokinetic profile (t_1/2 = 5.91 h) could clearly distinguish the ischemia-reperfusion (IR) liver with excessive NO in rats. Meanwhile, the temporarily reduced amount of NO in the IR liver and brain by the NO scavenger 2-phenyl-4,4,5,5-tetramethylimidazoline-3-oxide-1-oxyl could enhance the signal of Gd1d, suggesting anticipated NO-responsive property. This research offers a new avenue for insight into the NO spatiotemporal property in multiple IR organs.

2024-10-03·AMERICAN JOURNAL OF NEURORADIOLOGY

Different Glymphatic Kinetics in Spontaneous Intracranial Hypotension.

Article

作者: Duman Kavus, I E ; Volz, F ; Wolf, K ; Lützen, N ; Becker, L ; Urbach, H ; Rau, A ; El Rahal, A ; Zander, C ; Beck, J ; Kellner, E ; Reisert, M

BACKGROUND AND PURPOSE:

The glymphatic (glia-lymphatic) system is a paravascular pathway for the clearance of waste metabolites including amyloid β from the brain. Serial T1 relaxation time measurements after the intrathecal injection of gadolinium-based contrast agents facilitate the analysis of the temporal dynamics that may be different in patients with spontaneous intracranial hypotension (SIH) and those without SIH.

MATERIALS AND METHODS:

3D T1-weighted magnetization-prepared 2 rapid gradient echo sequences were acquired in 4 patients with SIH with proved CSF leaks and 12 patients without SIH before, 2-4, 6-8, and 24-48 hours after intrathecal gadobutrol injection. MR scans were warped to the Montreal Neurological Institute space and serial scans were coregistered. T1 relaxation times were measured in predefined ROIs including the subarachnoid space, cortex, white matter, and cervical lymph nodes.

RESULTS:

In the subarachnoid space and cortex, T1 relaxation times decreased after 2-4 and 6-8 hours before they increased again. In contrast, in the white matter of the temporal lobe T1 relaxation time still decreased after 24-48 hours. There was a striking difference in patients with SIH who did not show a clear contrast distribution within the brain parenchyma.

CONCLUSIONS:

T1 relaxation time curves are compatible with a convective flow driven by arterial pulsations via paravascular spaces surrounding penetrating arteries into the brain's interstitial fluid in the deep white matter. Different curves in patients with SIH and those without SIH indicate that the CSF pressure also impacts the temporal kinetics of the glymphatic system.

2024-09-01·Magnetic resonance imaging

Gadolinium-based contrast agents aggravate mechanical and thermal hyperalgesia in a nitroglycerine-induced migraine model in male mice

Article

作者: Adam, Muhammed ; Hekim, Munevver Gizem ; Bilgin, Batuhan ; Ozcan, Mete ; Bulut, Ferah

In the diagnosis of migraine, which is a neurovascular disease, gadolinium-based contrast agents (GBCAs) are used to rule out more serious conditions. On the other hand, it remains unclear as a scientific gap whether GBCAs may trigger migraine-related pain. The aim of this study was to investigate the effect of GBCAs on mechanical and thermal pain behaviour in a nitroglycerin (NTG)-induced migraine model in mice. NTG (10 mg/kg) was administered intraperitoneally to adult (6-8weeks old) BALB/c mice 2 h before behavioral tests 5 times every other day on days 1st, 3rd, 5th and 9th to induce migraine model (N = 50). As GBCAs, gadobenate dimeglumine (linear-ionic), Gadodiamide (linear-nonionic), and gadobutrol (macrocyclic-nonionic) were delivered intravenously through the tail vein of mice for 5 days on test days. Mechanical pain threshold (plantar and facial withdrawal threshold) was evaluated by plantar von Frey and periorbital von Frey tests on days 1st, 5th, and 9th, and thermal pain threshold (latency) was evaluated by hot plate and cold plate tests on days 3rd and 7th. There was a statistically significant increase in mechanical and thermal hyperalgesia in NTG administered groups compared to the control group. Gadodiamide, gadobutrol and gadobenate dimeglumine administration significantly decreased latency, paw and facial withdrawal threshold (0.18 ± 0.05, 0.17 ± 0.07, 0.16 ± 0.09; 9th day values respectively) compared to NTG group (0.27 ± 0.05). The results of this in vivo study show that GBCAs produce effects that may trigger migraine attacks in migraine. It is recommended that these effects be further investigated and supported by further clinical studies.

131

项与钆布醇相关的新闻（医药）

2024-10-29

·北陆药业

北陆药业前三季度营收稳健增长，净利润同比涨11倍！

近日，北陆药业（300016）发布《2024年第三季度报告》。2024年前三季度，公司继续稳健经营，实现营业收入7.30亿元，同比增长12.30%；归属于上市公司股东的净利润为2,439.43万元，同比增长1156.34%；归属于上市公司股东的扣除非经常性损益的净利润为2,521.87万元，同比增长275.59%。在“二次创业”理念的引领下，公司积极践行“化药+中药”的业务模式，通过深化中成药领域布局、积极拥抱集采政策以及拓展海外市场等多措并举，推动公司业绩实现稳步增长。营业收入稳定增长公司基本盘稳固 2024年第三季度，北陆药业营业收入为2.56亿元，较上年同期增长20.77%，在此影响下，前三季度营业收入为7.30亿元，较上年同期增长12.30%。公司继续推动纳入集采的对比剂产品及降糖类产品的集采执标工作，并积极推广其他未纳入集采的产品销售，同时海外市场业务进展顺利，公司营业收入持续稳定增长。盈利能力强力回升战略转型初现成效相对于营业收入的稳定增长，公司净利润等相关指标的改善更加显著。2024年前三季度，北陆药业的归母净利润、扣非后的归母净利润分别为2,439.43万元、2,521.87万元，较上年同期分别增长1156.34%和275.59%。公司的盈利能力逐步恢复，公司经营回归良性运作，公司的战略转型初现成效。推动并购重组加大中成药板块布局公司一直重视“并购重组”业务，今年已通过并购的方式收购承德天原药业80%的股权，并将其纳入公司合并范围。公司目前拥有59个中成药产品，北陆药业的九味镇心颗粒和天原药业的金莲花颗粒作为公司两大销售额过亿的“黄金单品”，不仅具有良好的市场竞争力，同时为公司打造中药品牌提供了极强的助力。随着公司对天原药业的整合与赋能，公司的中药板块将成为公司业绩持续增长的重要驱动力，有望成为公司的“第二增长曲线”。积极提升研发效率研发成果逐渐落地报告期内，公司继续调整研发组织架构，提高研发效率，在对比剂制剂及原料药、中枢神经、内分泌、消化、维生素、外用制剂等领域布局，研发立项更加多元。全资子公司艾湃克斯积极落实公司的各项研发任务，并取得了阶段性的进展。年初至今，公司钆布醇注射液（15ml:9.0708g）、盐酸帕罗西汀肠溶缓释片、钆特酸葡胺注射液及原料药、硫酸钠等获批上市。钆贝葡胺注射液（10ml : 5.290g）、钆喷酸葡胺注射液（10ml：4.69g、12ml：5.63g）通过仿制药质量和疗效一致性评价。控股子公司海昌药业碘克沙醇化学原料药获批上市，生产车间通过 GMP 符合性检查。丰富的产品储备让公司未来经营业绩有了更多的增长可能性。

上市批准一致性评价并购财报

2024-10-22

·普利制药300630

【战略合作招商】公司捷报频传，相继喜获多项证书｜安徽普利原料药钆布醇喜获WC，环磷酰胺喜获COPP，期待与您合作，共赢未来！

【战略合作招商】公司捷报频传，相继喜获多项证书｜安徽普利原料药钆布醇喜获WC，环磷酰胺喜获COPP，期待与您合作，共赢未来！海南普利制药股份有限公司（以下简称“普利制药”）控股子公司安徽普利药业有限公司（以下简称“安徽普利”）已于近日收到安徽省药品监督管理局签发的药用原料药钆布醇出口欧盟原料药证明文件（以下简称"WC"）及药用原料药环磷酰胺出口销售证明文件（以下简称"COPP"）。本次钆布醇WC证书的获得，表明该企业所实施的GMP符合中国药品GMP要求，等同于欧盟、世界卫生组织以及ICH Q7药品GMP 要求。同时环磷酰胺COPP证书的获得，表明该产品符合出口销售的要求，两个证书的获得都对推动产品海外市场推广和出口贸易带来积极影响。 1、钆布醇产品基本情况 1、产品基本情况介绍钆布醇是一种兼具高浓度和高弛豫率的大环状非离子型钆对比剂，显影更清晰，并且集合了对比增强成像的有效性和安全性，适用于全身全年龄段（包括足月新生儿）检查，包括肾功能不全患者。 2、市场情况根据IMS显示，除2020年受全球公共卫生事件影响，不可抗力导致的略微下降外，从2018年至2023年，钆布醇注射剂全球出厂销售额呈现平稳增长，2023年突破4亿美国的市场需求。全球原料药消耗量也呈平稳增长，2023年市场体量达到72吨规模。同比增长率较销售额更高，体现市场对原料药的需求量增长更快。 2023年全球制剂市场占比来看，以欧美市场为主，销售额前五分别为美国、法国、日本、土耳其、意大利，合计占比约57%。2023年全球原料药消耗量来看，市场消耗前五是美国、土耳其、中国、波兰、德国，合计占比65%，安徽普利钆布醇原料药已获得中国、美国、土耳其等主要市场的进入资格。 3、质量优势 1）可同时符合中、美、欧等多方药典标准；产品质量优于参比制剂，无机盐均严格控制，氯离子100ppm以下，锂离子25 ppm以下； 2）钆布醇API为稳定晶型，稳定性更优； 3）有专用生产线，产线自动化程度高，保证稳定供货，年产能可达到20吨以上； 4）可同时提供注射剂辅料考布曲钙钠； 4、注册法规优势本品已在中美等市场进行原料药备案/登记， ①其中US DMF号为039149（状态：A ）; ②CN登记号为Y20240000083，(状态: I ）；钆造影剂生产线车间已通过美国FDA现场检查，符合美国FDA的cGMP要求。其他市场的注册工作也在持续推进中。 2、环磷酰胺产品基本情况 1、产品基本情况介绍环磷酰胺属于烷化剂类细胞毒性药物，可干扰DNA及RNA功能，与DNA发生交叉联结，抑制DNA合成。制剂剂型包括片剂、胶囊和注射剂等，该药物抗瘤谱广，临床应用广泛，对恶性淋巴瘤、急性或慢性淋巴细胞、白血病等多种肿瘤均有一定的疗效。安徽普利年供货可达10吨，可为环磷酰胺不同制剂剂型（粉针剂、片剂、胶囊、注射剂）提供原料药供应。同时该产线是细胞毒产线，具备多种类型细胞毒产品的生产能力。 2、市场情况根据IMS数据库，2023年环磷酰胺的全球市场销售额高达2.75亿美元，2023年原料药消耗量全球10吨，从全球原料药需求市场来看，以巴西、中国、美国、印度、俄罗斯、日本、法国、德国、意大利、西班牙、英国为主，合计占比80%，安徽普利环磷酰胺原料药已获得主要市场的进入资格。 3、质量优势 1）产品质量与参比试剂相当，微生物限度严格控制，需氧菌总数＜10cfu/g，细菌内毒素≤0.025EU/mg； 2）细胞毒车间专线生产，年供货可达10t，产线自动化程度高，在保证稳定供货的基础上，产品质量更有保障。 4、注册法规优势本品已在中美欧等市场进行原料药备案/登记， ①其中US DMF号为037154（状态：A；且已有制剂引用，FAL通过）；环磷酰胺原料药在美国DMF上已通过技术审评，并收到美国食品药品监督管理局（FDA）签发的环磷酰胺原料First Adequate Letter（FAL）；车间于2023年通过FDA现场审查，药品生产符合美国 FDA的cGMP要求； ②CN登记号为Y20220000793（状态：A ），并已通过了国内注册核查和GMP符合性检查； ③CEP证书号：CEP 2022-356 - Rev 00，符合欧洲药典的质量要求；与此同时，公司也在积极推进其他市场的注册工作。 3、钆系列产品及环磷酰胺获批情况汇总 4、合作共赢安徽普利将利用自身产品优势，发挥国际注册的能力（已经在多国注册，并且有丰富的国际注册经验），借助国际化制造、质量控制体系和成熟的国际化市场开拓能力，愿与有志于开拓此产品的国内、国际制剂客户提供全方位、深度合作，共创未来。安徽普利安徽普利药业有限公司坐落于安庆国家高新技术产业开发区。是一家活性原料专业供应商，向全球医药、保健和护肤领域提供化学合成、生物合成的高品质特色原料。安徽普利目前拥有3个符合欧美中GMP标准的API 生产车间、10条生产线，357台多功能设备。依托强大的研发能力和技术转化能力，已完成造影剂（钆特酸葡胺、钆特醇、钆布醇、碘美普尔、碘普罗胺、碘佛醇、碘帕醇、碘克沙醇等）、合成生物学（司美格鲁肽、熊去氧胆酸、依克多因、红景天苷等）、抗肿瘤（BPA、环磷酰胺等）、其他原料药（盐酸多巴酚丁胺、硝普钠、氢氧化镁、阿普斯特、克立硼罗、伏立康唑、格隆溴铵、盐酸美金刚、特考韦瑞、阿昔洛韦钠、更昔洛韦钠、布美他尼、氟康唑、二硫化硒、别嘌醇等）、其他药用辅料（DOTA、SNAC、磺丁基-β-环糊精钠、卡特利多钙、考布曲钙钠等）等系列产品的研发与生产。欢迎垂询、欢迎合作！ Welcome for enquiry, cooperation！联系人：聂先生 Liangdeng Nie 电话：18857693467 邮箱：nieliangdeng@hnpoly.com 联系人：薛女士 Faye Xue 电话：13616530509 邮箱：ff@hnpoly.com

医药出海申请上市

2024-10-21

·米内网

集采冲击，造影剂明星药跌出TOP10！3大产品涨超10%，恒瑞、扬子江、南京正大天晴“突围”

精彩内容近期，造影剂市场波澜再起。北京北陆药业的钆喷酸葡胺注射液2个受理号过评；钆特酸葡胺注射液现身第十批集采网传报量名单。此前，海南倍特药业的钆特醇注射液、扬子江广州海瑞药业的钆布醇注射液等3个产品同日获批，原子高科的氟[18F]化钠注射液拿下首仿。米内网数据显示，2024年上半年中国公立医疗机构终端造影剂销售额同比增长1.65%，明星药跌出TOP10，3大产品涨超10%，恒瑞、扬子江、南京正大天晴4个国产品牌上榜。截至目前，造影剂有14个品种（近60个受理号）报产在审。造影剂首仿诞生，倍特、北陆药业领跑过评榜 10月18日，国家药监局官网显示，北京北陆药业的钆喷酸葡胺注射液2个受理号一致性评价补充申请获批。此前，海南倍特药业的钆特醇注射液、扬子江广州海瑞药业的钆布醇注射液等3个产品同日获批，成都克莱蒙医药的碘美普尔注射液成国产第2家，原子高科的氟[18F]化钠注射液拿下首仿。来源：米内网一键检索氟[18F]化钠注射液主要用于正电子发射断层显像（PET），在骨显像中确定成骨活性改变的区域，对诊断癌症骨转移、隐匿性骨折、冠状动脉斑块等病变具有重要的临床价值。目前，氟[18F]化钠注射液仅有原子高科拥有生产批文，南京江原安迪科正电子以仿制3类报产在审。原子高科表示，公司研制的氟[18F]化钠注射液是国内首个获批用于骨显像的PET显像剂，可实现早期、精准、无创的骨转移诊断，填补了我国在骨显像领域PET诊断显像剂的市场空白。今年以来造影剂报产获批、过评情况来源：米内网中国申报进度（MED）数据库今年以来，造影剂新品不断，已有12个品种（39个受理号）获批上市，无论是品种数还是受理号数，均已超过2023年全年（6个品种、10个受理号）。截至目前，造影剂已有14个品种（112个品规）过评，5个品种过评企业数量5家及以上，其中，碘克沙醇注射液过评企业最多，达9家。此外，江苏恒瑞医药的罂粟乙碘油注射液、原子高科的氟[18F]化钠注射液为独家过评。从企业过评品种数量来看，倍特药业最多，有8个品种过评，其次是北陆药业有7个，上海司太立制药有6个，恒瑞医药和正大制药各有5个。集采冲击，明星药跌出TOP10！恒瑞、扬子江、南京正大天晴“突围” 米内网数据显示，造影剂在2024年上半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）终端销售额同比增长1.65%。从集团TOP10格局来看，恒瑞医药、通用电气、拜耳、博莱科、扬子江药业位居前五；康臣药业增速最快，其次是上海司太立制药、博莱科、通用电气均超过10%。 2024年上半年中国公立医疗机构终端造影剂产品TOP10来源：米内网中国公立医疗机构药品终端竞争格局 2024年上半年有16个造影剂销售额超过1亿元，碘佛醇注射液、碘克沙醇注射液、碘海醇注射液位居前三。产品TOP10中，注射用六氟化硫微泡、碘美普尔注射液和碘海醇注射液增速均超过10%。 3个集采品种近年中国公立医院终端市场份额情况来源：米内网中国公立医疗机构药品终端竞争格局目前，造影剂有3个产品被纳入集采，第五批集采品种碘克沙醇注射液和碘海醇注射液市场份额均有所回升，分别排第二、三位；而第七批集采品种碘帕醇注射液在2023年销售额“腰斩”，2024年上半年已跌出造影剂TOP10产品之列。钆特酸葡胺注射液批文情况来源：米内网中国上市药品（MID）数据库近日，钆特酸葡胺注射液现身第十批集采网传报量名单，该产品在2024年上半年中国公立医疗机构终端是造影剂TOP8产品。目前有7家企业拥有生产批文，6家过评，山东新时代药业、华润双鹤药业3家报产在审。未来市场格局将会有何变化？米内网将持续关注。 2024年上半年中国公立医疗机构终端造影剂品牌TOP10来源：米内网中国公立医疗机构药品终端竞争格局品牌TOP10中，恒瑞医药的碘佛醇注射液和钆特酸葡胺注射液、扬子江药业集团的碘克沙醇注射液、南京正大天晴制药的碘克沙醇注射液4个国产品牌上榜。从数量来看，通用电气和博莱科各有3个，恒瑞医药和博莱科有2个上榜。 5个品牌增速亮眼，通用电气的碘海醇注射液和博莱科的注射用六氟化硫微泡均超过20%，博莱科的碘美普尔注射液、通用电气的碘克沙醇注射液、南京正大天晴制药的碘克沙醇注射液均超过10%。新品蜂拥而至，重庆药友制药、葫芦娃……发起冲击今年以来造影剂报产在审产品来源：米内网中国申报进度（MED）数据库近日，海南普利制药的钆布醇注射液有4个受理号以仿制4类报产在审。今年以来，造影剂已有24个受理号报产在审，涉及10个品种，其中，倍特药业的碘比醇注射液冲击首仿，海南葫芦娃药业集团的钆布醇注射液有望成为公司首款造影剂产品。截至目前，造影剂有近60个受理号报产在审，涉及14个品种。钆布醇注射液最为火热，有7家；碘普罗胺注射液，有5家，碘佛醇注射液和碘美普尔注射液均有4家。从企业报产在审品种数量来看，倍特药业最多（4个），其次是重庆圣华曦药业（3个）。资料来源：国家药监局官网、米内网数据库等注：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！本文为原创稿件，转载请注明来源和作者，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

一致性评价上市批准带量采购医药出海

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,

后查看更多信息

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 \| LEADER 75, CTgov)	临床4期	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	網簾膚廠憲醖繭衊積繭(鏇窪醖糧顧鹽鏇衊蓋壓) = 範繭獵淵鹹範鑰願蓋醖遞鹹齋膚積夢積範蓋醖 (夢淵襯網鹹壓鏇鹽艱窪, 簾夢願鏇鑰遞夢遞廠壓 ~ 鬱淵襯鹹淵壓壓窪憲簾) 更多	-	2021-04-28
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	網簾膚廠憲醖繭衊積繭(鏇窪醖糧顧鹽鏇衊蓋壓) = 選獵淵選鹽顧齋夢齋網遞鹹齋膚積夢積範蓋醖 (夢淵襯網鹹壓鏇鹽艱窪, 願憲夢窪膚衊鑰網夢築 ~ 鹽簾網築繭夢繭願蓋廠) 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	製衊廠齋膚窪願顧構簾(艱鏇糧觸鏇齋鏇醖觸網) = 襯襯範願顧齋淵膚獵夢窪鑰範顧夢醖蓋鬱願範 (構構蓋廠願選範鏇製選, 繭獵願範簾糧鑰鏇積鹹 ~ 構淵鏇夢積襯選衊鑰膚) 更多	-	2021-02-08
NCT01890434 (GadaCAD 2, CTgov)	临床3期	冠心病	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	糧構選憲積淵範願糧範(選糧艱鏇夢淵獵繭繭觸) = 觸鑰鬱壓膚蓋製網積壓膚餘鏇糧築獵壓淵夢觸 (願襯蓋餘膚齋窪選構餘, 糧憲鑰構鹽窪餘齋蓋遞 ~ 顧夢衊範膚觸壓鹽衊鬱) 更多	-	2018-05-16
NCT01890421 (GadaCAD 1, CTgov)	临床3期	冠心病	426	Gadobutrol (Gadovist, Gadavist, BAY86-4875)	鏇鹹範蓋鏇鹹醖顧醖範(淵築網範構廠鬱願構遞) = 淵壓夢鬱構鹹憲糧窪衊鬱選鏇鹹積鬱簾選鏇艱 (衊窪衊遞餘遞鬱築憲膚, 積蓋鬱膚遞鹽齋積簾壓 ~ 鹽範顧願鹹選壓選網衊) 更多	-	2018-05-16
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) 人工标引	N/A	造影剂	23,708	gadobutrol	齋鑰繭糧選鹹製鹹獵鑰(鹽淵遞齋衊簾簾壓製糧) = 範製遞築積製範衊窪願構鹹蓋鬱構選衊壓艱膚 (顧餘鏇淵鹹獵遞窪齋築 ) 更多	积极	2017-01-01
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) 人工标引	临床3期	肿瘤	906	Gadobutrol	網壓鏇醖製夢構選獵積(憲簾膚選鹹蓋襯選壓鑰) = 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. 築觸鏇積膚簾繭獵網餘 (餘蓋鏇願築憲簾衊壓築 )	积极	2016-07-01
NCT01344460 (GRAMS, Biospace) 人工标引	临床3期	血管疾病	292	Gadobutrol	壓觸獵襯壓構壓醖鹹鹹(鬱壓遞築鏇齋襯繭廠衊) = 鏇願觸衊廠願觸網鬱鬱選窪蓋壓衊鬱鬱蓋醖顧 (壓膚遞鑰鏇鹹壓衊蓋憲 ) 更多	积极	2016-04-29
NCT01490294 (CTgov)	临床2期	心肌缺血	232	Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))	艱顧構淵鬱壓鹽鹽網獵(鑰遞鹹製襯蓋壓鹽選蓋) = 鏇憲蓋遞鏇獵鏇鏇夢餘齋壓醖壓夢廠網窪餘網 (窪鹹獵鑰壓齋鑰範鬱淵, 膚膚壓憲淵選願廠繭鏇 ~ 憲衊獵衊餘簾膚艱壓顧) 更多	-	2012-06-28
NCT01490294 (CTgov)	临床2期	心肌缺血	232	Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))	艱顧構淵鬱壓鹽鹽網獵(鑰遞鹹製襯蓋壓鹽選蓋) = 構觸製鹹夢鑰憲製膚糧齋壓醖壓夢廠網窪餘網 (窪鹹獵鑰壓齋鑰範鬱淵, 鏇艱膚願獵廠衊構遞鹽 ~ 選願壓夢願鏇製築膚鬱) 更多	-	2012-06-28
NCT00395460 (CTgov)	临床3期	脊柱疾病 \| 中枢神经系统疾病	147	Magnevist	壓齋顧窪廠鏇壓製鏇淵(壓膚願鏇餘憲顧鏇構構) = 窪淵網夢顧蓋餘簾繭餘觸齋簾製鹽憲齋淵網繭 (鬱獵觸網淵鹽構鬱積齋, 蓋夢糧觸選糧鏇糧選襯 ~ 鹽簾積艱鹽淵積鬱鬱艱) 更多	-	2011-11-01