更新于：2024-12-09

Gadobutrol

钆布醇

更新于：2024-12-09

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

+ [1]

非在研机构

Bayer Schering Pharma AGBayer Vital GmbH

拜耳医药保健有限公司

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)批准上市

特殊审评-

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结构

分子式C18H31GdN4O9

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CAS号770691-21-9

关联

项与钆布醇相关的临床试验

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

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

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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750

项与钆布醇相关的文献（医药）

2024-12-01·NMR IN BIOMEDICINE

Characterizing diffusion‐controlled release of small‐molecules using quantitative MRI in view of applications to orthopedic infection

Article

作者: Drangova, Maria ; Khazaee, Tina ; Holdsworth, David W. ; Liu, Junmin ; Hong, Greg ; Cobos, Santiago F. ; Christiansen, Spencer D.

Abstract:

Calcium sulfate is an established carrier for localized drug delivery, but a means to non‐invasively measure drug release, which would improve our understanding of localized delivery, remains an unmet need. We aim to quantitatively estimate the diffusion‐controlled release of small molecules loaded into a calcium sulfate carrier through a gadobutrol‐based contrast agent, which acts as a surrogate small molecule. A central cylindrical core made of calcium sulfate, either alone or within a metal scaffold, is loaded with contrast agents that release into agar. Multi‐echo scans are acquired at multiple time points over 4 weeks and processed into R2* and quantitative susceptibility mapping (QSM) maps. Mean R2* values are fit to a known drug delivery model, which are then compared with the decrease in core QSM. Fitting R2* measurements of calcium sulfate core while constraining constants to a drug release model results in an R2‐value of 0.991, yielding a diffusion constant of 4.59 × 10−11 m2 s−1. Incorporating the carrier within a metal scaffold results in a slower release. QSM shows the resulting loss of susceptibility in the non‐metal core but is unreliable around metal. R2* characterizes the released gadobutrol, and QSM detects the resulting decrease in core susceptibility. The addition of a porous metal scaffold slows the release of gadobutrol, as expected.

2024-12-01·INVESTIGATIVE RADIOLOGY

Relationship of Dose and Signal Enhancement Properties of Gadoquatrane, a New Tetrameric, Macrocyclic Gadolinium-Based Contrast Agent, Compared With Gadobutrol

Article

作者: Riecke, Kai ; Palkowitsch, Petra ; Klein, Stefan ; Posch, Helena ; Klemens, Mark A ; Ebert, Wolfgang ; Kahn, Johannes F ; Berse, Matthias ; Hofmann, Birte M

Objectives:

To investigate the signal-enhancement properties of the tetrameric gadolinium-based contrast agent (GBCA) gadoquatrane in relation to the administered dose and compare its properties to those of a standard dose of gadobutrol, as a representative of the currently established macrocyclic GBCAs for magnetic resonance imaging.

Materials and Methods:

In this randomized, single-blind, 4 × 4 crossover study, 43 healthy adults (19–50 years of age) received 3 single IV injections of gadoquatrane (0.01, 0.03, and 0.06 mmol gadolinium/kg body weight) and 1 injection of gadobutrol (0.1 mmol gadolinium/kg body weight) in randomized sequence with 1-week washout periods between administrations. The relative signal enhancement (RSE) was determined in predefined areas of interest in magnetic resonance image sets of the head-neck region. RSE-vs-dose curves (dose-response curves) were established by linear regression, and comparator-equivalent doses were determined by Bayesian inverse regression analysis. Further, 3 blood samples were taken after each injection for pharmacokinetic analyses, and safety data were assessed.

Results:

The RSE increased with gadoquatrane dose. A linear function adequately fitted this relationship. In line with the more than 2-fold higher r1 relaxivity of gadoquatrane per gadolinium ion, gadobutrol-equivalent RSE was achieved with gadoquatrane at less than half the gadolinium dose and less than one eighth of the molecule dose.Administration of gadoquatrane and gadobutrol resulted in very similar dose-normalized gadolinium concentrations in plasma, indicating that the pharmacokinetic profiles are essentially the same. Both contrast agents were well tolerated. Adverse events were rare and not dependent on the dose administered.

Conclusions:

Gadoquatrane has the potential to be an effective GBCA that can be used at substantially lower doses in clinical routine than the currently established macrocyclic GBCAs.

2024-12-01·ACADEMIC RADIOLOGY

Prospective Deployment of Deep Learning Reconstruction Facilitates Highly Accelerated Upper Abdominal MRI

Article

作者: Werner, Sebastian ; Brendlin, Andreas S ; Fritz, Victor ; Almansour, Haidara ; Herrmann, Judith ; Brendel, Jan M ; Afat, Saif ; Nickel, Dominik ; Nikolaou, Konstantin ; Schick, Fritz ; Jacoby, Johann ; Gassenmaier, Sebastian ; Dehdab, Reza ; Ursprung, Stephan

RATIONALE AND OBJECTIVES:

To compare a conventional T1 volumetric interpolated breath-hold examination (VIBE) with SPectral Attenuated Inversion Recovery (SPAIR) fat saturation and a deep learning (DL)-reconstructed accelerated VIBE sequence with SPAIR fat saturation achieving a 50 % reduction in breath-hold duration (hereafter, VIBE-SPAIR_DL) in terms of image quality and diagnostic confidence.

MATERIALS AND METHODS:

This prospective study enrolled consecutive patients referred for upper abdominal MRI from November 2023 to December 2023 at a single tertiary center. Patients underwent upper abdominal MRI with acquisition of non-contrast and gadobutrol-enhanced conventional VIBE-SPAIR (fourfold acceleration, acquisition time 16 s) and VIBE-SPAIR_DL (sixfold acceleration, acquisition time 8 s) on a 1.5 T scanner. Image analysis was performed by four readers, evaluating homogeneity of fat suppression, perceived signal-to-noise ratio (SNR), edge sharpness, artifact level, lesion detectability and diagnostic confidence. A statistical power analysis for patient sample size estimation was performed. Image quality parameters were compared by a repeated measures analysis of variance, and interreader agreement was assessed using Fleiss' κ.

RESULTS:

Among 450 consecutive patients, 45 patients were evaluated (mean age, 60 years ± 15 [SD]; 27 men, 18 women). VIBE-SPAIR_DL acquisition demonstrated superior SNR (P < 0.001), edge sharpness (P < 0.001), and reduced artifacts (P < 0.001) with substantial to almost perfect interreader agreement for non-contrast (κ: 0.70-0.91) and gadobutrol-enhanced MRI (κ: 0.68-0.87). No evidence of a difference was found between conventional VIBE-SPAIR and VIBE-SPAIR_DL regarding homogeneity of fat suppression, lesion detectability, or diagnostic confidence (all P > 0.05).

CONCLUSION:

Deep learning reconstruction of VIBE-SPAIR facilitated a reduction of breath-hold duration by half, while reducing artifacts and improving image quality.

SUMMARY:

Deep learning reconstruction of prospectively accelerated T1 volumetric interpolated breath-hold examination for upper abdominal MRI enabled a 50 % reduction in breath-hold time with superior image quality.

KEY RESULTS:

1) In a prospective analysis of 45 patients referred for upper abdominal MRI, accelerated deep learning (DL)-reconstructed VIBE images with spectral fat saturation (SPAIR) showed better overall image quality, with better perceived signal-to-noise ratio and less artifacts (all P < 0.001), despite a 50 % reduction in acquisition time compared to conventional VIBE. 2) No evidence of a difference was found between conventional VIBE-SPAIR and accelerated VIBE-SPAIR_DL regarding lesion detectability or diagnostic confidence.

132

项与钆布醇相关的新闻（医药）

2024-12-03

·摩熵医药

倍特药业拿下29亿+注射剂，4大品种同日获批！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 12月02日，据NMPA官网公示，倍特药业有4款注射剂同日获批生产并视同过评，包含碘佛醇注射液、尼莫地平注射液、卡络磺钠注射液和子公司海南倍特药业的注射用盐酸罗沙替丁醋酸酯。其中碘佛醇注射液是造影剂TOP1产品，成为公司第9款造影剂，该品种在2023年全国院内市场的销售额超29亿元。截图来源：NMPA 29亿造影剂，国内仅3家药企迎来过评碘佛醇注射液是临床广泛应用的造影剂之一，属于非离子型、低渗、水溶性且X线不透射的造影剂，主要通过血管内给药。其作用原理在于，造影剂注入血管后，能使流经的血管区域呈现不透光性，从而在X光照射下清晰显影。该产品于1988年率先获得美国FDA批准上市，1999年成功引入中国市场，2000年被纳入国家医保乙类目录，2009年更进一步升级至医保甲类目录。据摩熵医药数据库显示，碘佛醇注射液在2023年全国院内市场的销售额超29亿元，同比增长达10.69%，同时碘佛醇注射液是2023年造影剂院内TOP1品种。截图来源：摩熵医药（原药融云）全国医院销售数据库截至目前，已有5家药企获得了碘佛醇注射液的生产批文，其中包括2家进口药企及3家国内药企。在过评方面，碘佛醇注射液在国内仅江苏恒瑞医药、成都倍特药业以及上海司太立制药这3家迎来过评。截图来源：摩熵医药（原药融云）过评药品汇总数据库倍特药业在造影剂领域的产品线不断壮大，目前已有9款品种获批，2022年成都倍特药业的首款造影剂碘普罗胺注射液获批，2023年成都倍特药业拿下了碘帕醇注射液和碘克沙醇注射液。今年以来，倍特药业（含子公司）有碘佛醇注射液、钆塞酸二钠注射液、钆布醇注射液、钆特酸葡胺注射液、钆特醇注射液、钆贝葡胺注射液6个品种陆续上市，倍特药业（含子公司）的造影剂已累计有9款。截图来源：摩熵医药（原药融云）中国药品审评数据库其中钆特酸葡胺注射液、碘克沙醇注射液、碘帕醇注射液和碘普罗胺注射液4个品种均已登上2023年全国医院内销售造影剂的TOP10榜单。截图来源：摩熵医药（原药融云）全国医院销售数据库 37款品种扎堆过评，两款产品压线进入十批集采倍特药业此番成功获批的注射用盐酸罗沙替丁醋酸酯与尼莫地平注射液，均被列为第十批国家集采药品，可谓是“压线”入场。其中盐酸罗沙替丁醋酸酯是一款组胺H2受体拮抗剂，主要是治疗与胃酸分泌相关疾病的药物，临床上用于上消化道出血（由消化性溃疡，急性应激性溃疡，出血性胃炎等引起）的低危患者。近年来，注射用盐酸罗沙替丁醋酸酯销售规模持续上涨，据摩熵医药数据库显示，注射用盐酸罗沙替丁醋酸酯在2023年全国院内市场的销售额逼近10亿元。截图来源：摩熵医药（原药融云）全国医院销售数据库截至目前，国内已有四川汇宇制药、扬子江药业、海南倍特药业、瑞阳制药、江苏奥赛康药业等17家企业的注射用盐酸罗沙替丁醋酸酯过评或视同过评。截图来源：摩熵医药（原药融云）过评药品汇总数据库此外，尼莫地平注射液目前有超40家药企拥有生产批文，该品种可用于预防和治疗动脉瘤性蛛网膜下腔出血后脑血管痉挛引起的缺血性神经损伤。在仿制药布局方面，该品种还有四川科伦药业、四川美大康佳乐药业、山东华铂凯盛生物科技等5家药企提交了4类注册仿制申请。截图来源：摩熵医药（原药融云）中国药品审评数据库 2024年至今，倍特药业（含子公司）有37款品种迎来过评，其中注射用头孢唑肟钠、呋塞米口服溶液、钆贝葡胺注射液3款品种为首家过评。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准医药出海申请上市核酸药物

2024-12-03

·米内网

【重磅】倍特药业大丰收！4款注射剂同日获批

精彩内容近日，国家药监局官网显示，倍特药业4款注射剂同日获批生产并视同过评，分别为卡络磺钠注射液、注射用盐酸罗沙替丁醋酸酯、碘佛醇注射液及尼莫地平注射液，其中碘佛醇注射液2023年在中国公立医疗机构终端的销售额超过30亿元，注射用盐酸罗沙替丁醋酸酯、尼莫地平注射液均为第十批集采品种。今年以来，倍特药业有31个品种获批生产并视同过评。注射用盐酸罗沙替丁醋酸酯、尼莫地平注射液均为第十批集采品种，倍特药业“压线”获得入场券。罗沙替丁是一种组胺H2受体拮抗剂，适用于上消化道出血（由消化性溃疡、急性应激性溃疡、出血性胃炎等引起）的低危患者。国内已上市的罗沙替丁制剂仅注射用盐酸罗沙替丁醋酸酯一种，该产品2022年在中国城市公立医院、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）终端的销售额超过14亿元，2023年回落至接近12亿元，2024上半年有所回升。从最新厂家竞争格局看，北京轩升制药（已过评）以约66%的市场份额领跑，哈药生物（已过评）以约23%的市场份额紧接在后，瑞阳制药（已过评）以约11%的市场份额排位第三。近年来中国公立医疗机构终端注射用盐酸罗沙替丁醋酸酯销售情况（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国内已有17家企业的注射用盐酸罗沙替丁醋酸酯过评或视同过评，包括重庆药友制药、四川汇宇制药、扬子江药业、江苏奥赛康药业、海南倍特药业等。在第十批集采中，该产品最高采购额（首年约定采购量*最高有效申报价，下同）超过7000万元。碘佛醇注射液是一款经血管用药的非离子、低渗透、水溶性、不透射线造影剂，目前已被纳入国家医保甲类目录。含倍特药业在内，有3家国内企业的碘佛醇注射液视同过评，该产品2023年在中国公立医疗机构终端的销售额突破30亿元，2024上半年有所回落。近年来中国公立医疗机构终端碘佛醇注射液销售情况（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在造影剂领域，倍特药业已拥有9款产品的生产批文，分别为碘普罗胺注射液、碘帕醇注射液、碘克沙醇注射液、钆贝葡胺注射液、钆特酸葡胺注射液、碘佛醇注射液、钆塞酸二钠注射液、钆特醇注射液、钆布醇注射液。米内网数据显示，今年以来，倍特药业（含子公司）有1款2.2类改良型新药获批上市，为盐酸右美托咪定鼻喷雾剂，公司为国内第2家获批；此外，31个品种获批生产并视同过评，包括6个造影剂、4个心脏病治疗用药、3个高血压用药、3个糖尿病用药、2个全身用抗细菌药、2个止血药等。今年以来倍特药业获批上市的品种来源：米内网中国申报进度（MED）数据库 31个仿制药中，多个品种为国内首批上市。其中，呋塞米口服溶液为国内首仿+首家过评，钆特酸葡胺注射液、罗沙司他胶囊、钆贝葡胺注射液为第2家仿制，钆特醇注射液、酮咯酸氨丁三醇片、碘佛醇注射液、马来酸氟伏沙明片、钆塞酸二钠注射液、马来酸阿伐曲泊帕片为国产第3家等。资料来源：米内网数据库、国家药监局官网等注：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。数据统计截至12月3日，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 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

带量采购上市批准申请上市一致性评价医药出海

2024-11-28

·摩熵医药

35款新药IND获批！79个品种过评，涉及康弘药业、丹红制药等药企……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 PART 01 周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵数据统计，新药申请与审批活动频繁，显示出医药创新领域的活跃态势。本文将深入分析11月18日至11月24日期间，国内外新药申请、临床试验批准、仿制药一致性评价以及医药投融资等多个方面的最新进展，为用户提供全面的行业资讯。 PART 02 国内35款新药IND获批根据摩熵数据统计，11月18日至11月24日期间，共有67个创新药/改良型新药临床申请/上市申请获CDE承办（按受理号统计，不含补充申请）。其中，国产药品受理号53个，进口药品受理号14个。本周共计35款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药19款，生物药15款，中药1款。本周获批临床创新药/改良型新药（部分）信息速览(不含补充申请) 注：完整数据可识别“文末”二维码下载查看 PART 03 本周全球TOP10创新药研发进展在全球创新药研发领域，11月18日，三生国健宣布该公司递交的重组抗 IL-17A 人源化单克隆抗体注射液（SSGJ-608）上市申请已获得中国国家药品监督管理局受理，用于治疗成人中重度斑块状银屑病。次日，美国 FDA 已受理Aldeyra Therapeutics所重新提交用于治疗干眼症的创新眼用药物reproxalap的新药申请（NDA），该申请的PDUFA日期为2025年4月2日。此外，华东医药、百济神州、和黄医药/武田等药企取得新进展。本周全球 TOP10 创新药研发进展截图来源：摩熵咨询周报 PART 04 79个品种过评，涉及康弘药业、丹红制药等药企根据摩熵数据统计，11月18日至11月24日期间，共有100项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号92项（包括化药3类，4类，5.2类），新注册分类临床申请受理号7项（包括化药3类，4类），一致性评价申请1项；共10个品种通过一致性评价（按受理号计18项），本周69个品种视同通过一致性评价（按受理号计112项）。本周有3项生物类似物注册申报动态，分别是华兰基因工程有限公司的利妥昔单抗注射液（按受理号计有2项）和齐鲁制药有限公司的注射用重组人促卵泡激素。本周过评/视同过评品种主要为神经系统药物，过评/视同过评产品剂型主要为注射剂；本周利伐沙班片、米诺地尔搽剂和甲硫酸新斯的明注射液过评/视同过评受理号数量最多有4个，硫酸镁钠钾口服用浓溶液是本周过评/视同过评企业数最多的品种有3家。截图来源：摩熵咨询周报在企业层面，本周山东丹红制药有限公司、北大医药股份有限公司和成都康弘药业集团股份有限公司等多家企业过评/视同过评品种数最多有2种，其余各企业过评/视同过评品种数紧随其后，本周过评/视同过评企业共包括山东丹红制药有限公司、北大医药股份有限公司和成都康弘药业集团股份有限公司等83家企业。截图来源：摩熵咨询周报本周有酒石酸托特罗定缓释胶囊、硫酸异帕米星注射液、磷酸芦可替尼片等5个品种首次过评/视同过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报本周有注射用利福平、钆布醇注射液、盐酸氮卓斯汀滴眼液、硫酸镁钠钾口服用浓溶液4个品种过评/视同过评达5家企业。截图来源：摩熵咨询周报根据摩熵数据统计，11月18日至11月24日期间，全球医药大健康行业共发生投融资事件74起，较上次数量增加了15起，其中创新药类融资共31起，医疗/医药技术投资热度也较高，本周占比为31%，为23起。截图来源：摩熵咨询周报国内医药大健康行业共发生投融资事件20起，较上周数量增加了2起，其中医疗/医药技术、医疗器械耗材融资事件分别发生2起、6起；其中邦耀生物、百明信康、领泰生物、通瑞生物融资金额在1亿元人民币以上。截图来源：摩熵咨询周报本周国内创新药大类，抗肿瘤药物研发为热点。如需获取更多行业信息，请订阅摩熵咨询周报。摩熵咨询本期完整周报识别二维码领取下载往期周报回顾 # 37款新药IND获批！68个品种过评，涉及山东新时代药业…… # 26款新药IND获批！63个品种过评，涉及石家庄四药等多家药企…… # 53款新药IND获批！43个品种过评，涉及石药集团…… # 33款新药IND获批！58个品种过评，涉及齐鲁制药晴…… END 本文为原创文章，转载请留言获取授权更多详细报告获取方式后台回复关键词“周报1”，获取2月26日-3月3日周报PDF。后台回复关键词“周报2”，获取3月4日-3月10日周报PDF。后台回复关键词“周报3”，获取3月11日-3月17日周报PDF。后台回复关键词“周报4”，获取3月18日-3月24日周报PDF。后台回复关键词“周报5”，获取3月25日-03月31日周报PDF。后台回复关键词“周报6”，获取4月1日-4月7日周报PDF版。后台回复关键词“周报7”，获取4月8日-4月14日周报PDF版。后台回复关键词“周报8”，获取4月15日-4月21日周报PDF版。近期最新周报识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，了解更多品牌升级详情！

一致性评价临床申请生物类似药

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)	築願糧鑰齋壓齋構憲醖(壓簾鑰醖夢膚憲廠廠積) = 蓋衊構齋選蓋簾餘襯積選鏇膚窪鏇範製膚網膚 (築築廠網繭獵齋廠壓襯, 構壓積構顧鹹獵願憲範 ~ 簾積廠鹽醖鬱憲願窪廠) 更多	-	2021-04-28
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	築願糧鑰齋壓齋構憲醖(壓簾鑰醖夢膚憲廠廠積) = 齋鹹願觸憲鏇鑰鏇鬱壓選鏇膚窪鏇範製膚網膚 (築築廠網繭獵齋廠壓襯, 憲糧鏇蓋齋醖築構鹽築 ~ 壓製鹽繭憲醖範艱鏇壓) 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	獵夢膚築淵艱選鹽鑰糧(淵糧鹹遞顧夢襯觸願衊) = 窪廠蓋蓋獵憲積願積構醖糧構壓蓋餘鑰蓋鹽淵 (憲鏇壓艱憲觸鹽網淵鬱, 夢糧淵鹽壓顧憲夢積窪 ~ 廠選壓鹹鹽願範壓簾憲) 更多	-	2021-02-08
NCT01890421 (GadaCAD 1, CTgov)	临床3期	冠心病	426	Gadobutrol (Gadovist, Gadavist, BAY86-4875)	鬱襯鏇繭網齋構窪鑰範(鑰觸蓋淵構範鹽齋觸鹹) = 鑰願範鏇壓鬱鑰積餘鏇醖製積選餘繭獵顧選範 (窪糧艱構醖鹹鹹遞蓋積, 繭廠鏇餘鹽夢鹹夢襯網 ~ 蓋鏇構選壓願遞簾鹹齋) 更多	-	2018-05-16
NCT01890434 (GadaCAD 2, CTgov)	临床3期	冠心病	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	壓範淵選鏇鹽夢壓範簾(淵壓鏇窪鬱願積鏇顧鏇) = 糧鬱獵選餘餘醖窪窪醖齋遞遞觸鹽壓膚網鹹廠 (憲選製蓋壓築鹹鹽遞築, 憲壓願簾壓窪鑰淵壓繭 ~ 遞襯壓夢鑰齋選醖築鏇) 更多	-	2018-05-16
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) 人工标引	N/A	造影剂	23,708	gadobutrol	遞憲鑰網繭夢獵觸顧願(積願網廠膚壓願醖構蓋) = 齋餘蓋餘構範願糧願製遞鑰餘窪鏇網築範鏇廠 (衊鏇願醖鏇願廠膚構製 ) 更多	积极	2017-01-01
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) 人工标引	临床3期	肿瘤	906	Gadobutrol	製鬱壓壓襯製憲繭網積(膚壓夢窪製構製選獵築) = 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. 憲夢鏇餘鏇簾願窪齋壓 (齋壓壓繭網鬱艱糧網顧 )	积极	2016-07-01
NCT01344460 (GRAMS, Biospace) 人工标引	临床3期	血管疾病	292	Gadobutrol	製築製築觸鬱廠築餘夢(觸觸選醖築醖遞糧廠廠) = 範襯鹽製鬱齋鹽繭顧壓網遞襯繭範齋窪蓋簾襯 (繭壓鏇網膚觸觸製窪壓 ) 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))	壓築觸選製淵憲觸餘簾(遞遞製蓋壓夢鏇遞簾齋) = 齋鏇顧壓構繭願窪窪積糧衊廠鬱糧鏇糧餘齋構 (鑰餘觸繭夢醖積觸簾積, 蓋繭憲艱淵簾積餘觸餘 ~ 願憲獵獵壓襯醖範繭製) 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))	壓築觸選製淵憲觸餘簾(遞遞製蓋壓夢鏇遞簾齋) = 觸鬱廠窪選糧選淵衊積糧衊廠鬱糧鏇糧餘齋構 (鑰餘觸繭夢醖積觸簾積, 糧鏇醖齋鏇餘憲廠鑰衊 ~ 蓋製鹹壓願網觸構築網) 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	觸願積鏇鑰選顧構構廠(簾夢艱積衊壓窪鬱齋鏇) = 壓鏇範蓋艱積襯願製選壓簾築網願窪憲鹽壓艱 (壓膚夢糧襯繭窪憲網簾, 構衊繭鑰廠膚糧範獵遞 ~ 願醖餘淵鑰艱遞遞願憲) 更多	-	2011-11-01