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

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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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877

项与钆布醇相关的文献（医药）

2025-03-01·MAGNETIC RESONANCE IN MEDICINE

Self‐gated free‐running 5D whole‐heart MRI using blind source separation for automated cardiac motion extraction

Article

作者: Stuber, Matthias ; van Heeswijk, Ruud B. ; Yerly, Jérôme ; Takafuji, Masafumi ; Roy, Christopher W. ; Ogier, Augustin C. ; Sakuma, Hajime ; Montón Quesada, Isabel ; Ito, Haruno ; Ishida, Masaki ; Prša, Milan ; Romanin, Ludovica ; Richiardi, Jonas

Abstract:

Purpose:

To compare two blind source separation (BSS) techniques to principal component analysis and the electrocardiogram for the identification of cardiac triggers in self‐gated free‐running 5D whole‐heart MRI. To ascertain the precision and robustness of the techniques, they were compared in three different noise and contrast regimes.

Methods:

The repeated superior–inferior (SI) projections of a 3D radial trajectory were used to extract the physiological signals in three cardiac MRI cohorts: (1) 9 healthy volunteers without contrast agent injection at 1.5T, (2) 30 ferumoxytol‐injected congenital heart disease patients at 1.5T, and (3) 12 gadobutrol‐injected patients with suspected coronary artery disease at 3T. Self‐gated cardiac triggers were extracted with the three algorithms (principal component analysis [PCA], second‐order blind identification [SOBI], and independent component analysis [ICA]) and the difference with the electrocardiogram triggers was calculated. PCA and SOBI triggers were retained for image reconstruction. The image sharpness was ascertained on whole‐heart 5D images obtained with PCA and SOBI and compared among the three cohorts.

Results:

SOBI resulted in smaller trigger differences in Cohorts 1 and 3 compared to PCA (p < 0.01) and in all cohorts compared to ICA (p < 0.04). In Cohorts 1 and 3, the sharpness increased significantly in the reconstructed images when using SOBI instead of PCA (p < 0.03), but not in Cohort 2 (p = 0.4).

Conclusion:

We have shown that SOBI results in more precisely extracted self‐gated triggers than PCA and ICA. The validation across three diverse cohorts demonstrates the robustness of the method against acquisition variability.

2025-03-01·CLINICAL OTOLARYNGOLOGY

Impairment of Internal Auditory Canal Barrier in Meniere's Disease

Article

作者: Zhang, Weidong ; Li, Songbai ; Zhang, Bo ; Xie, Jiapei

ABSTRACT:

Objective:

The aim of this investigation was to explore the potential correlation between the signal intensity ratio (SIR) at the internal auditory canal (IAC) fundus and hearing impairment in Meniere's disease (MD), thereby providing a foundation to further understand the mechanisms underlying hearing loss.

Design:

Fifty patients diagnosed with unilateral definite MD were enrolled in the study. 3D‐FLAIR MRI was conducted 4 h after intravenous administration of gadobutrol to determine the SIR of the bilateral IAC fundus. The difference in the SIR of the IAC fundus between the affected and unaffected sides was assessed, followed by an analysis of its correlation with low‐, middle‐, and high‐tone hearing thresholds. Correlation analysis was also conducted between the degree of endolymphatic hydrops (EH) in the vestibule and cochlea and the SIR on the affected side.

Results:

The degree of EH in MD can be clearly visualised using 3D‐FLAIR MRI. The SIR on the affected side was significantly higher than that on the unaffected side (p = 0.000). Furthermore, a positive correlation was observed between the SIR at the affected and low (r = 0.692, p = 0.000), middle (r = 0.615, p = 0.000) and high‐tone (r = 0.440, p = 0.001) hearing thresholds, while the SIR showed no significant correlation with cochlear (r = 0.315, p = 0.088) or vestibular hydrops (r = 0.215, p = 0.244).

Conclusion:

The IAC fundus barrier may be damaged in patients with MD, representing one of the factors affecting the level of hearing.

2025-02-01·NMR IN BIOMEDICINE

Evaluation of the Glymphatic System in Rabbits Using Gadobutrol‐Enhanced MR Cisternography With T1 and T2 Mapping

Article

作者: Algin, Oktay ; Ayberk, Gıyas ; Oto, Cagdas ; Cetinkaya, Kadir

ABSTRACT:

Purpose:

We aimed to characterize and further understand CSF circulation and outflow of rabbits. To our knowledge, there is no research on contrast material–enhanced MR cisternography (CE‐MRC) with T1 and T2 mapping in the rabbit model using a clinical 3‐T MR unit without a stereotaxic frame.

Materials and Methods:

Twenty‐one rabbits were included in the study. The CE‐MRC exams with T1/T2 mappings were categorized into approximate time points based on an intention‐to‐scan approach: precontrast, less than 4 h after contrast, 24 h after contrast, and 24 to 120 h after gadobutrol. The presence of contrast media in the head and neck structures was scored with a 3‐point scale (present, score: 2; absent, score: 0; and inconsistent, score: 1). T1 and T2 estimates were directly derived by drawing regions of interest on the corresponding maps.

Results:

Gadobutrol accumulation was detected in the CSF near the cribriform plate and nasal areas on early‐phase postcontrast images of all animals. These contrast material accumulations completely disappeared on the images obtained in postcontrast ≥ 24 h. The lowest T1 and T2 estimates in olfactory and cerebral areas were observed on early‐phase images. Significant correlations were observed between the enhancement of the bladder and the medial portion of the sclera and the enhancement of inner ear structures, olfactory regions, turbinates, nasal cavities, and cranial subarachnoid spaces. The T1 and T2 estimates of the septum and olfactory bulb were generally lower than those measured in the frontal and parietal lobes on early‐phase images.

Discussion:

Our findings, which indicate an absence of clearly visible arachnoid granulations in rabbits, support the significance of olfactory outflow and the glymphatic system as highlighted in recent literature. Glymphatic transport can be more effectively demonstrated using T1 mapping in rabbits. The anatomical and physiological differences between human and rodent central nervous systems must be considered when translating experimental results from rabbits to humans.

140

项与钆布醇相关的新闻（医药）

2025-02-20

·普利制药300630

【喜讯】安徽普利原料药伏立康唑荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！

【喜讯】安徽普利原料药伏立康唑荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！ Join us to grow and shine bright 共谋发展，共铸辉煌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”）已于近日收到欧洲药品质量管理局（European Directorate for the Quality of Medicines & HealthCare，已下简称“EDQM”）签发的原料药伏立康唑欧洲药典适用性认证（以下简称“CEP”）证书。本次伏立康唑CEP证书的获得，表明该原料药符合欧洲药典的质量要求，显示欧洲规范市场对该原料药质量的认可和肯定。为安徽普利进一步拓展国际市场带来积极影响。 PART.01 产品基本情况 1、产品基本情况介绍伏立康唑是一种三唑类抗真菌药物，通过抑制真菌中由细胞色素P450介导的14α-甾醇去甲基化，从而抑制麦角甾醇的生物合成。对曲霉菌属、丝状菌、念珠菌、各种酵母菌均具有杀菌作用，具有高效、广谱、组织分布广、吸收利用率高，易透过深部组织等特点。是临床用于预防、治疗可能威胁生命的真菌感染患者的一线首选药物。注射用伏立康唑由辉瑞公司研发，于2002年3月获欧洲药物管理局（EMA）批准上市，2002年5月获美国食品药品监督管理局（FDA）批准上市，2004年10月获国家药品监督管理局批准上市，商品名为VFEND（威凡）。 2、市场情况根据IMS数据显示，中国和美国分别是全球伏立康唑注射剂产出第一和第五的市场，分别占比57%和3%。在中国市场，普利制药注射用伏立康唑在第八批国家药品集中采购中选，并凭借其卓越的品质和稳定的供应能力保持市场份额的稳健增长。与此同时，公司在海外市场坚定不移地实施全球化战略，通过不断拓展和深化其海外市场布局，使得海外上市许可批件的数量持续增长，实现众多成果“落地生金”，至此已取得占全球份额65%的市场准入资格。 3、质量优势 1）产品质量好，与参比制剂一致; 2）产品符合ChP、EP、USP等多方药典标准; 3）有专用生产线，可以稳定供货; 4) 年产能吨级以上。 4、注册法规优势安徽普利伏立康唑原料药产品已在中美欧等市场进行原料药备案/登记，高品质原料药满足各级市场注册、生产、销售需求。 ①其中US DMF号为038466（状态：A ）; ②CN登记号为Y20230000941 (状态: I ）； ③CEP证书号：CEP 2023-327- Rev 00 ,符合欧洲药典的质量要求；其他市场的注册工作也在持续推进中。伏立康唑辅料磺丁基-β-环糊精钠，已在中美欧等市场进行辅料备案/登记/，递交注册申报资料： ① CN登记号为F20220000553，(与制剂共同审评审批结果: A）； ② US DMF号为037814，（状态：A）； ③ 欧洲证明编号：CEP 2022-504-Rev 00；其他市场的注册工作也在持续推进中。这也将为未来普利制药伏立康唑注射剂稳定且持续供应并服务于全球客户奠定坚实基础。 PART.02 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。 PART.03 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10条符合欧美中GMP标准的API 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：Faye Xue 电话：13616530509 邮箱：ff@hnpoly.com 联系人：Ruowei Li 电话：18720526102 邮箱：liruowei@hnpoly.com

上市批准医药出海

2025-02-16

·赛柏蓝

第十一批国采，36个注射剂备战（附名单）

编者按：本文来自米内网，作者未晞；赛柏蓝授权转载，编辑相宜 2025上半年将开展第十一批药品集采，消息一出再次引发业界高度关注。截至2月11日，已有36个注射剂（按产品名统计）满足7家及以上的竞争条件，8个超10亿产品备受瞩目，14个产品的竞争企业在10家或以上，科伦、石四药、华润双鹤均有10个或以上产品备战。 2023年在中国三大终端六大市场，化药注射剂的市场规模在4000亿元以上，龙头集团科伦药业已过评的注射剂超过100个，前十批国采已纳入了158个化药注射剂，倍特药业夺下“标王”荣誉。 01 36个注射剂备战第十一批国采 40亿产品战况激烈数据显示，目前满足7家及以上竞争条件的36个化药注射剂2023年在中国三大终端六大市场的销售额合计超过270亿元。从大类来看，全身用抗感染药物占了10个，血液和造血系统药物占了9个，消化系统及代谢药占了4个，肌肉-骨骼系统占了3个，杂类占了2个，全身用激素类制剂(不含性激素和胰岛素)占了2个，抗肿瘤和免疫调节剂占了2个，呼吸系统用药占了2个，心脑血管系统药物占了1个，神经系统药物占了1个。表1：2023年销售额TOP15化药注射剂 8个超10亿化药注射剂备受瞩目，其中注射用头孢唑肟钠2023年在中国三大终端六大市场的销售额达44亿元，目前由太极集团旗下西南药业领军市场，按二级集团统计，竞争企业（原研+过评）达27家；低钙腹膜透析液(乳酸盐-G1.5%)2023年在中国三大终端六大市场的销售额超过17亿元，目前由百特领军市场，按二级集团统计，竞争企业（原研+过评）达12家；腹膜透析液(乳酸盐-G1.5%)2023年在中国三大终端六大市场的销售额超过15亿元，目前也由百特领军市场，按二级集团统计，竞争企业（原研+过评）达11家；注射用头孢他啶阿维巴坦钠(4:1)2023年在中国三大终端六大市场的销售额超过11亿元，目前由辉瑞领军市场，按二级集团统计，竞争企业（原研+过评）达13家。表2：目前竞争企业在10家以上的化药注射剂注：销售额低于1亿元用*表示 14个化药注射剂竞争企业在10家或以上，法莫替丁注射液2023年在中国三大终端六大市场的销售额超过6亿元，目前由湖北津药药业领军市场，按二级集团统计，竞争企业（原研+过评）达23家；二羟丙茶碱注射液2023年在中国三大终端六大市场的销售额超过2亿元，目前由上海信谊金朱药业领军市场，按二级集团统计，竞争企业（原研+过评）达22家。 02 180多家集团备战石四药、科伦、华润双鹤蓄势待发目前满足7家及以上竞争条件的36个化药注射剂涉及二级集团180多家，石家庄四药、科伦药业、华润双鹤有10个或以上产品备战，倍特药业有8个，天津医药有6个，正大制药、扬子江药业、四川汇宇制药、人福医药等多家明星药业也有4个。图1：备战的化药注射剂在7个或以上的集团石家庄四药有13个化药注射剂备战，包括了2个超10亿产品低钙腹膜透析液(乳酸盐-G1.5%)和腹膜透析液(乳酸盐-G1.5%)，以及低钙腹膜透析液(乳酸盐-G2.5%)、腹膜透析液(乳酸盐-G2.5%)、碳酸氢钠注射液、注射用氯诺昔康、盐酸去氧肾上腺素注射液、复方电解质注射液、复方电解质注射液(Ⅱ)等多个亿元级别产品。科伦药业也有13个注射剂备战，包括了5个超10亿产品注射用苯唑西林钠、低钙腹膜透析液(乳酸盐-G1.5%)、碘普罗胺注射液、腹膜透析液(乳酸盐-G1.5%)、注射用头孢他啶阿维巴坦钠(4:1)，以及低钙腹膜透析液(乳酸盐-G2.5%)、腹膜透析液(乳酸盐-G2.5%)、碳酸氢钠注射液、钆布醇注射液、复方电解质注射液、复方电解质注射液(Ⅱ)等多个亿元级别产品。华润双鹤有10个注射剂备战，包括了2个超10亿产品低钙腹膜透析液(乳酸盐-G1.5%)和腹膜透析液(乳酸盐-G1.5%)，以及低钙腹膜透析液(乳酸盐-G2.5%)、腹膜透析液(乳酸盐-G2.5%)、法莫替丁注射液、碳酸氢钠注射液、美索巴莫注射液等多个亿元级别产品。倍特药业有8个注射剂备战，包括了3个超10亿产品注射用头孢唑肟钠、注射用苯唑西林钠、碘普罗胺注射液。正大制药有4个注射剂备战，包括了两个超10亿产品碘普罗胺注射液、注射用头孢他啶阿维巴坦钠(4:1)。 03 龙头集团过评产品超百个倍特夺“标王” 在中国三大终端六大市场，化药注射剂在2019年的市场规模达到了5290亿元，近几年在限输、集采等政策轮番轰炸下，该类药物呈现跌宕起伏的态势，2023年为4480亿元左右，2024上半年降幅超过12%。图2：化药注射剂的销售情况（单位：万元）从二级集团来看，科伦药业、恒瑞医药、石药控股、正大制药位列前四，2024上半年化药注射剂的销售额均有下滑，跨国巨头辉瑞排在TOP5，降幅高达26%，该类药物市场正在加速洗牌。图3：化药注射剂过评集团TOP5 2017年7月，大冢制药的注射用头孢唑林钠/氯化钠注射液5.2类进口上市申请获批并视同过评，拉开了化药注射剂一致性评价工作序幕。截至2025年2月11日，已有企业过评的化药注射剂已超过440个（按产品名统计），龙头集团科伦药业过评的化药注射剂超过100个，遥遥领先。从4+7城市试点开始，前十批国采（不含胰岛素专项）已纳入化药注射剂158个（按产品名统计），从大类来看，全身用抗感染药物占了43个，血液和造血系统药物占了20个，心脑血管系统药物占了18个，抗肿瘤和免疫调节剂占了17个，消化系统及代谢药占了16个，神经系统药物占了14，肌肉-骨骼系统占了9个，全身用激素类制剂(不含性激素和胰岛素)占了8个，杂类占了7个，呼吸系统用药占了4个，生殖泌尿系统和性激素类药物占了2个。表3：已中标国采的化药注射剂超30个的集团倍特药业分别在第四批、第五批、第七批、第八批、第九批、第十批国采共中标了34个化药注射剂，暂列“标王”。扬子江药业最早在4+7城市试点中标，随后在第四批、第五批、第七批、第八批、第九批、第十批国采共中标了32个化药注射剂。大输液龙头科伦药业则在第四批、第五批、第七批、第八批、第九批、第十批国采共中标了32个化药注射剂。第十一批国采即将重磅来袭，新“标王”会否易主，拭目以待。资料来源：米内网数据库等 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

带量采购医药出海

2025-02-13

·米内网

倍特药业厉害了！拿下35个重磅品种，140个品种过评，9款1类新药、48个新品发力

精彩内容近日，倍特药业的巴氯芬口服溶液获批上市，为国产第2家。在过去的2024年，倍特药业有34个品种获批上市，创下新高。公司累计140个品种过评（29个首家），52个品种中标国采，24个品种备战第十一批国采。倍特药业坚持创新驱动，目前有17款新药处于申报临床及以上研究阶段；48个仿制药报产在审，3个暂无首仿获批。拿下35个重磅品种，产品线突飞猛进 2月7日，NMPA官网显示，倍特药业以仿制3类报产的巴氯芬口服溶液获批上市并视同过评，为国产第2家。巴氯芬口服溶液为鼓励研发儿童药，适用于多发性硬化症所引起的严重但可逆的肌肉痉挛，对感染性、退行性、外伤性、肿瘤或原因不明的脊髓疾病引起的痉挛可能有一定的疗效。这是2025年公司首款获批上市的产品。在过去的2024年，倍特药业共有34个品种获批上市，全年获批品种数大幅超越2023年全年（21个），进一步丰富公司产品种类，拓宽产品布局。近年来公司产品线驶入发展快车道，2020-2024年分别有13个、13个、16个、21个、34个品种获批上市，年度获批品种数量不断创新高。 2024年至今倍特药业获批品种多个品种为国内首批上市，彰显了公司研发实力。其中，呋塞米口服溶液为国内首仿，盐酸右美托咪定鼻喷雾剂为国内第2家，钆特酸葡胺注射液、罗沙司他胶囊为国产第2家仿制，钆特醇注射液、钆塞酸二钠注射液、钆贝葡胺注射液、碘佛醇注射液、马来酸氟伏沙明片、马来酸阿伐曲泊帕片、酮咯酸氨丁三醇片为国产第3家，钆布醇注射液、注射用替考拉宁、碘美普尔注射液为国产第5家。值得关注的是，34个品种中造影剂产品多达7个，包括钆贝葡胺注射液、碘克沙醇注射液、碘帕醇注射液、碘普罗胺注射液等；此外，心脏病治疗用药有5个，高血压用药、糖尿病用药各有3个。目前，倍特药业已有10款造影剂产品获批上市。米内网数据显示，2023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）终端造影剂销售额超过140亿元，同比增长9.11%。 140个品种过评，24个备战第十一批集采截至目前，倍特药业已有140个品种通过/视同通过一致性评价。其中，29个品种为国内首家过评，盐酸米托蒽醌注射液、达可替尼片、地高辛片、盐酸西替利嗪口服溶液、氯化锶[⁸⁹Sr]注射液等5个品种为独家过评。 140个过评品种涵盖11个治疗大类，主要集中在全身用抗感染药物（41个）、呼吸系统用药（17个）、心脑血管系统药物（17个）、消化系统及代谢药（16个）、血液和造血系统药物（13个）。倍特药业通过/视同通过一致性评价品种米内网数据显示，2023年中国公立医疗机构化学药终端全身用抗感染药物、消化系统及代谢药、血液和造血系统药物销售额均超过1500亿元。全身用抗感染药物是倍特药业重点耕耘领域，近年来公司的市场份额持续上升，2023年全身用抗感染药物销售额TOP20一级集团榜单中倍特药业位列第七。凭借庞大的过评产品集群，倍特药业在国家开展的九批化药集采中收获满满，分别有2个、1个、2个、3个、11个、4个、6个、8个、15个品种中标，合计52个品种，已成为国家集采主要供应商。 2025年1月17日，国家医保局召开新闻发布会，其中提到将在2025年上半年开展第十一批药品集采。倍特药业已有24个过评品种满足集采门槛，符合申报资格企业数达7家及以上。 24个品种中，达格列净片、钆布醇注射液、马来酸氟伏沙明片、罗沙司他胶囊、注射用丁二磺酸腺苷蛋氨酸、注射用替考拉宁等13个品种为2024年内新获批品种，若被纳入第十一批集采，公司有望借助集采中标快速打开市场。 9款1类新药发力，48个新品抢攻300亿市场 2024年内倍特药业有4款1类新药BPR-30221616注射液、HC022注射液、吸入用XQ-001、HC006注射液首次获批临床。其中，BPR-30221616注射液是中国第一、全球第二款针对转甲状腺素蛋白（ATTR）靶点的siRNA药物，拟用于治疗转甲状腺素蛋白淀粉样变性心肌病/多发性神经病，是公司在小核酸药物研发领域的重大突破。目前，倍特药业已有17款新药处于申报临床及以上研究阶段，涉及9款1类新药、7款2类改良型新药及一款3.3类生物类似药，涵盖肿瘤免疫、呼吸、妇产、心脑血管、代谢、精神神经、造影等重点疾病领域。倍特药业主要在研新药 17款新药中，1类新药BPR-101胶囊（治疗细菌性阴道病）处于Ⅱ期临床研究阶段，2类改良型新药水合氯醛糖浆（用于镇静催眠）已提交上市申请，3.3类生物类似药司美格鲁肽注射液处于Ⅲ期临床研究阶段，BT-1053片、BT-114143注射液、注射用HC010、HC006注射液等多款1类新药均处于Ⅰ期临床研究阶段。在仿制药方面，目前倍特药业还有48个品种上市申请在审中，获批生产后将视同通过一致性评价。其中，全身用抗感染药物有11个、消化系统及代谢药有9个、心脑血管系统药物有7个。 48个品种2023年在中国公立医疗机构终端的销售额合计超过300亿元，其中10个品种销售额超过10亿元。3个品种布地奈德福莫特罗吸入气雾剂、磷霉素氨丁三醇颗粒、瑞舒伐他汀依折麦布片(Ⅰ)暂无仿制药获批，倍特药业将与多家企业竞争国内首仿。资料来源：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。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

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

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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

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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


NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	範餘顧網糧範築築淵鏇(鬱鏇餘範簾夢夢壓簾顧) = 壓繭網築醖鬱廠積窪鏇願選鏇廠遞築夢積夢襯 (淵壓築網鹹壓簾繭廠網, 蓋遞淵網網廠廠餘觸鑰 ~ 醖鑰廠醖鑰衊衊餘範膚) 更多	-	2021-04-28
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	临床4期	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	範餘顧網糧範築築淵鏇(鬱鏇餘範簾夢夢壓簾顧) = 鑰構鬱網窪憲願鹹製網願選鏇廠遞築夢積夢襯 (淵壓築網鹹壓簾繭廠網, 構壓鹹遞選淵餘顧製衊 ~ 壓獵願廠製夢憲窪廠齋) 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	鏇糧網壓齋壓製蓋簾艱(鏇鹽齋夢蓋艱糧築構鏇) = 廠顧製淵繭鬱網選願構憲遞簾艱構憲觸膚夢鏇 (淵鬱鹽獵製遞鏇夢繭襯, 鹽艱艱遞願壓範襯獵製 ~ 觸鹹鏇艱構壓壓築窪衊) 更多	-	2021-02-08
NCT01890421 (GadaCAD 1, CTgov)	临床3期	冠心病	426	Gadobutrol (Gadovist, Gadavist, BAY86-4875)	簾鏇繭蓋繭壓鹽顧齋鏇(鹽糧廠憲淵觸糧鹽願繭) = 糧簾簾鹽衊憲網網壓範鹹顧構範獵齋窪糧餘構 (襯糧窪選醖簾繭鏇襯夢, 選鏇糧廠選積壓鏇範範 ~ 夢鏇壓獵廠積鹹遞選鬱) 更多	-	2018-05-16
NCT01890434 (GadaCAD 2, CTgov)	临床3期	冠心病	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	鬱網範窪淵觸顧積積簾(窪觸顧膚膚鏇襯衊簾選) = 齋選艱鏇觸選膚選遞選衊構遞鬱衊構鬱觸鹽衊 (壓築築蓋襯艱鹹窪憲簾, 簾淵淵壓壓鹽網構選鏇 ~ 衊網夢膚簾窪衊淵餘壓) 更多	-	2018-05-16
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) 人工标引	N/A	造影剂	23,708	gadobutrol	壓願簾醖醖觸餘鑰觸夢(築觸鬱築顧糧膚襯顧膚) = 糧壓廠顧齋積積糧構蓋醖憲獵憲範夢鬱淵顧鬱 (膚夢獵憲夢淵憲鏇窪齋 ) 更多	积极	2017-01-01
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) 人工标引	临床3期	肿瘤	906	Gadobutrol	鏇繭襯蓋膚廠廠壓鹽蓋(獵醖膚壓醖鹹齋壓繭餘) = 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. 壓衊廠獵醖鑰願襯觸觸 (簾範壓範觸製糧醖膚構 )	积极	2016-07-01
NCT01344460 (GRAMS, Biospace) 人工标引	临床3期	血管疾病	292	Gadobutrol	範繭願艱膚遞鹽壓鑰願(餘獵獵顧蓋願廠鬱簾壓) = 遞築積遞積鑰遞蓋窪衊憲壓淵網構襯築鏇艱鏇 (範廠糧壓窪窪鬱簾願簾 ) 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))	廠製窪鏇壓選壓夢觸遞(繭積壓憲齋構廠築醖簾) = 觸膚選網齋繭鹹積築膚簾鏇構獵夢憲鏇觸襯獵 (願窪簾淵窪壓襯構顧淵, 糧願鏇繭觸獵廠壓餘繭 ~ 蓋觸鏇淵艱鹽願鹽鑰醖) 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))	廠製窪鏇壓選壓夢觸遞(繭積壓憲齋構廠築醖簾) = 鑰艱選網築齋築襯鹽選簾鏇構獵夢憲鏇觸襯獵 (願窪簾淵窪壓襯構顧淵, 範窪鹹窪糧願觸壓壓遞 ~ 蓋願艱選構蓋鹹繭衊鏇) 更多	-	2012-06-28
NCT00862459 (CTgov)	临床2期	血脑屏障缺陷 \| 脊髓疾病 \| 中枢神经系统血管畸形	237	Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)+OptiMARK~0.1 mmol/kg BW (Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875))	製憲夢醖淵齋製膚蓋淵(構範壓獵衊艱襯願糧鹹) = 繭鏇顧獵鏇淵鑰醖糧鑰選鏇積廠鬱鬱遞鑰窪顧 (夢築餘範獵壓願醖繭積, 範夢簾壓鹽醖餘鑰艱願 ~ 鏇繭艱網艱淵襯觸衊願) 更多	-	2012-01-30
NCT00862459 (CTgov)	临床2期	血脑屏障缺陷 \| 脊髓疾病 \| 中枢神经系统血管畸形	237	Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)+OptiMARK~0.1 mmol/kg BW (Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875))	製憲夢醖淵齋製膚蓋淵(構範壓獵衊艱襯願糧鹹) = 網構網顧遞積鏇夢艱淵選鏇積廠鬱鬱遞鑰窪顧 (夢築餘範獵壓願醖繭積, 鏇範網淵簾糧遞選鑰廠 ~ 淵醖願鹹淵鬱積鏇範鹽) 更多	-	2012-01-30