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

NCT05357833

/ Completed早期临床1期IIT

Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis

This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.

开始日期2022-06-01

申办/合作机构

University of Utah

100 项与钆特醇相关的临床结果

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100 项与钆特醇相关的转化医学

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100 项与钆特醇相关的专利（医药）

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512

项与钆特醇相关的文献（医药）

2026-01-02·Expert Opinion On Drug Safety

Anaphylactic risk associated with iodinated and gadolinium-based contrast media

Article

作者: Cui, Le ; Bian, Sainan ; Guan, Kai ; Xue, Huadan ; Wang, Zixi ; Zhao, Bin ; Li, Lisha ; Xu, Yingyang

BACKGROUND:

This study aimed to analyze the risk signals of iodinated and gadolinium-based contrast media associated with anaphylaxis.

RESEARCH DESIGN AND METHODS:

Data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) were retrospectively reviewed from January 2004 to September 2022. Disproportionality and Bayesian analyses were used in data mining to screen for suspected anaphylaxis using contrast media.

RESULTS:

A total of 1240 reports of anaphylaxis associated with contrast media were identified (464 men, 37.4%). The average age of anaphylaxis associated with iodinated contrast media (ICM) and gadolinium-based contrast media (GBCM) was 56.8 ± 17.2 and 50.9 ± 18.0 years old, respectively (p < .001). Among ICM, iopamidol showed the highest reporting odds ratio (ROR) (29.0), and amidotrizoate showed the lowest ROR (7.4). Among low-osmolality ICM, iopamidol had the highest ROR (29.0), and iopromide had the lowest ROR (8.8). Among the macrocyclic agents, gadoteridol had the highest ROR (37.3), while gadoterate meglumine had the lowest (10.4). Among the linear agents, gadobenate dimeglumine had the highest ROR (28.8), and gadodiamide had the lowest (1.4). The mortality rate in ICM was significantly higher than that in GBCM (p < 0.001).

CONCLUSIONS:

This study provides clinicians and pharmacists evidence for risk signals of anaphylactic reactions among contrast agents.

2025-10-01·ANALYTICA CHIMICA ACTA

Interaction study between gadolinium-based contrast agents and lysozyme using frontal analysis continuous capillary electrophoresis

Article

作者: Chamieh, Joseph ; Rousseaux, Olivier ; Somnin, Chutintorn ; Leclercq, Laurent ; Cottet, Hervé ; Medina, Christelle

BACKGROUND:

Gadolinium-based contrast agents (GBCA) are widely used in magnetic resonance imaging (MRI) to enhance image contrast. However, their interactions with biological macromolecules remain an important area of investigation due to potential safety concerns. Developing robust analytical methods to study these interactions is essential for improving safety assessments and guiding the design of next-generation contrast agents.

RESULTS:

In this study, we employed Frontal Analysis Continuous Capillary Electrophoresis (FACCE) to investigate the binding interactions between lysozyme, a model protein, and several GBCA, including Gd-DTPA (Gadopentetate, Magnevist®), Gd-BOPTA (Gadobenate, Multihance®), Gd-DOTA (Gadoterate, Dotarem®), Gd-PCTA D2 (Gadopiclenol, Elucirem™) and Gd-HP-DO3A (Gadoteridol, Prohance®). Our results demonstrate that GBCA exhibit varying degrees of cooperative binding to lysozyme, with stoichiometry (n) of 4 for Gd-DTPA, Gd-BOPTA, and Gd-DOTA. The strength of interactions followed the trend: Gd-BOPTA (Multihance®) > Gd-DTPA (Magnevist®) > Gd-DOTA (Dotarem®), while Gd-PCTA D2 (Elucirem™) showed no significant binding. However, FACCE was unable to resolve interactions for Gd-HP-DO3A (Prohance®) due to interference with lysozyme.

SIGNIFICANCE:

FACCE is a well-adapted method to investigate GBCA-protein interaction. It requires low sample volumes and allows determining the stoichiometry, binding constant, and cooperativity of the interaction. This work emphasizes the cooperative nature of the GBCA-lysozyme interactions and indicates that the Hill model is suitable for analysing the interactions within the tested concentration range of GBCAs.

2025-09-01·FOOD CHEMISTRY

The aroma evolution in lotus (Nelumbo nucifera Gaertn.) seed juice: A comprehensive analysis of processing and low-temperature storage effects

Article

作者: Jiang, Xiangfu ; Lu, Xu ; Zhou, Taoyi ; Mao, Sirui ; Lei, Qiuming ; Zheng, Baodong ; Huang, Zhanhong ; Zhou, Fuzhen ; Ma, Shuang

Lotus seed juice has significant potential in the plant-based beverage market owing to its distinctive flavor. However, its sensory quality is significantly influenced by processing and storage conditions. This study examined the effects and underlying mechanisms of fresh squeezing, sterilization, and refrigeration at 4 °C (for 1-6 months) on the aroma profile of lotus seed juice using an electronic nose, gas chromatography-ion mobility spectrometry (GC-IMS), and non-targeted metabolomics. Sterilization processes resulted in vanilla, mint, and ammonia-like flavors due to the accumulation of hexanal, pentanal, and pyrrolidine. One month of refrigeration enhanced fruity and minty flavors, attributed to increased acetone and 6-ethyl acetate-D from fatty acid oxidation and esterification, respectively. However, prolonged refrigeration (six months) introduced undesirable alcoholic and pungent off-flavors caused by slow oxidative degradation (such as 2-propanol and 1-hydroxy-2-propanone). These findings provide valuable insights for improving the preservation methods and quality control strategies for plant-based beverages.

115

项与钆特醇相关的新闻（医药）

2026-03-08

·信狐药迅

海思科1类创新化药HSK39297提交上市申请|新受理（3.2-3.8）

本周药品注册受理数据，分门别类呈现，一目了然。(3.1-3.8）新药上市申请药品名称企业注册分类受理号 HSK39297片四川海思科制药有限公司 1 CXHS2600039 甲磺酸阿美替尼片江苏豪森药业集团有限公司 2.4 CXHS2600038 新药临床申请药品名称企业注册分类受理号 SYH2095片杭州英创医药科技有限公司 1 CXHL2600281 SYH2095片杭州英创医药科技有限公司 1 CXHL2600280 HS-10541片江苏豪森药业集团有限公司 1 CXHL2600279 HS-10541片江苏豪森药业集团有限公司 1 CXHL2600278 D3S-003片德昇济医药(无锡)有限公司 1 CXHL2600276 GNTbm-38 2HCl 胶囊诺为泰医药科技(上海)有限公司 1 CXHL2600275 GNTbm-38 2HCl 胶囊诺为泰医药科技(上海)有限公司 1 CXHL2600274 Alpha-0261片上海阿尔法分子企业发展有限责任公司 1 CXHL2600272 Alpha-0261片上海阿尔法分子企业发展有限责任公司 1 CXHL2600271 注射用LY103 青岛海洋生物医药研究院股份有限公司 1 CXHL2600266 注射用LY103 青岛海洋生物医药研究院股份有限公司 1 CXHL2600265 QR055453D片武汉朗来科技发展有限公司 1 CXHL2600270 QR055453D片武汉朗来科技发展有限公司 1 CXHL2600269 QR055453D片武汉朗来科技发展有限公司 1 CXHL2600268 JYP0061片广州嘉越医药科技股份有限公司 1 CXHL2600261 JYP0061片广州嘉越医药科技股份有限公司 1 CXHL2600260 QLS1413片上海齐鲁制药研究中心有限公司 1 CXHL2600264 QLS1413片上海齐鲁制药研究中心有限公司 1 CXHL2600263 YKYY018雾化吸入剂北京悦康科创医药科技股份有限公司 1 CXHL2600254 注射用LPM5260558 山东全重生物医药科技有限公司 1 CXHL2600253 YKYY018雾化吸入剂北京悦康科创医药科技股份有限公司 1 CXHL2600252 JYP0061片广州嘉越医药科技股份有限公司 1 CXHL2600259 DSC158A片太极集团重庆涪陵制药厂有限公司 1 CXHL2600258 DSC158A片太极集团重庆涪陵制药厂有限公司 1 CXHL2600257 DSC158A片太极集团重庆涪陵制药厂有限公司 1 CXHL2600256 盐酸R-氯胺酮注射液宜昌人福药业有限责任公司 2.1 CXHL2600267 BCM993 上海云晟研新生物科技股份有限公司 2.2 CXHL2600277 玛硒洛沙韦干混悬剂征祥医药(南京)集团股份有限公司 2.2 CXHL2600262 阿莫西林伏诺拉生胃漂浮片南京三迭纪医药科技有限公司 2.2 CXHL2600255 TM001 哈尔滨田美药业股份有限公司 2.4 CXHL2600273 重组呼吸道合胞病毒疫苗(CHO细胞) 易康生物(苏州)有限公司 1.2 CXSL2600311 重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂) 易康生物(苏州)有限公司 1.2 CXSL2600309 冻干口服轮状减毒活疫苗(Vero细胞) 成都迈科康生物科技股份有限公司 2.2 CXSL2600315 三价流感病毒裂解疫苗(MDCK细胞) 北京科兴生物制品有限公司 2.2 CXSL2600289 注射用MK-1045 默沙东研发(中国)有限公司 1 CXSL2600312 GR1803注射液(皮下注射) 重庆智翔金泰生物制药股份有限公司 1 CXSL2600313 RLX-2505注射液苏州拓界医药有限公司 1 CXSL2600310 注射用MK-1045 默沙东研发(中国)有限公司 1 CXSL2600314 SYS6063注射液石药集团中奇制药技术(石家庄)有限公司 1 CXSL2600308 注射用SHR-A2102 苏州盛迪亚生物医药有限公司 1 CXSL2600306 注射用SHR-A2009 苏州盛迪亚生物医药有限公司 1 CXSL2600304 HS-20117注射液上海翰森生物医药科技有限公司 1 CXSL2600303 注射用AMT-116 普众发现医药科技(上海)股份有限公司 1 CXSL2600301 HS-20117-2注射液上海翰森生物医药科技有限公司 1 CXSL2600290 注射用BR111 杭州博之锐生物制药有限公司 1 CXSL2600295 GA002注射液健达九州(北京)生物科技有限公司 1 CXSL2600299 注射用BAT8013 百奥泰生物制药股份有限公司 1 CXSL2600298 注射用RC288 荣昌生物制药(烟台)股份有限公司 1 CXSL2600288 SKB118注射液四川科伦博泰生物医药股份有限公司 1 CXSL2600292 注射用BG-C0979 广州百济神州生物制药有限公司 1 CXSL2600291 伏欣奇拜单抗注射液长春金赛药业有限责任公司 2.1;2.2 CXSL2600285 伏欣奇拜单抗注射液长春金赛药业有限责任公司 2.1;2.2 CXSL2600284 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSL2600305 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSL2600296 SHR-8068注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2600300 贝伐珠单抗注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2600297 仿制药申请药品名称企业注册分类受理号磷苯妥英钠注射用浓溶液福安药业集团烟台只楚药业有限公司 3 CYHS2600629 磷苯妥英钠注射用浓溶液福安药业集团烟台只楚药业有限公司 3 CYHS2600628 盐酸西替利嗪口服溶液北京韩美生物科技有限公司 3 CYHS2600618 盐酸西替利嗪口服溶液北京韩美生物科技有限公司 3 CYHS2600617 盐酸西替利嗪口服溶液北京韩美生物科技有限公司 3 CYHS2600616 醋酸葡萄糖维持液成都赛诺联创生物科技有限公司 3 CYHS2600615 醋酸葡萄糖维持液成都赛诺联创生物科技有限公司 3 CYHS2600614 乙酰半胱氨酸片河北瑞森药业有限公司 3 CYHS2600621 加巴喷丁口服溶液上海上药中西制药有限公司 3 CYHS2600612 氨溴特罗口服溶液河北山姆士药业有限公司 3 CYHS2600611 铝碳酸镁混悬液安徽康融药业有限公司 3 CYHS2600606 马尿酸乌洛托品片成都恒瑞制药有限公司 3 CYHS2600602 氨磺必利口服溶液四川森科制药有限公司 3 CYHS2600599 洛度沙胺氨丁三醇滴眼液石家庄四药有限公司 3 CYHS2600598 乙酰半胱氨酸注射液湖北午时药业股份有限公司 4 CYHS2600625 注射用磷酸左奥硝唑酯二钠江西远超医药科技有限公司 4 CYHS2600624 聚乙烯醇滴眼液曼秀雷敦(中国)药业有限公司 4 CYHS2600623 二甲双胍恩格列净片(I) 广州仁恒医药科技股份有限公司 4 CYHS2600622 二甲双胍恩格列净片(V) 广州仁恒医药科技股份有限公司 4 CYHS2600620 二甲双胍恩格列净片(VI) 广州仁恒医药科技股份有限公司 4 CYHS2600619 复方托吡卡胺滴眼液珠海前列药业有限公司 4 CYHS2600613 钆特醇注射液北京北陆药业股份有限公司 4 CYHS2600609 非奈利酮片天津力生制药股份有限公司 4 CYHS2600608 非奈利酮片天津力生制药股份有限公司 4 CYHS2600607 钆特醇注射液北京北陆药业股份有限公司 4 CYHS2600610 盐酸阿莫罗芬乳膏江西众泽源医药科技有限公司 4 CYHS2600605 达格列净片华益药业科技(安徽)有限公司 4 CYHS2600601 达格列净片华益药业科技(安徽)有限公司 4 CYHS2600600 盐酸阿罗洛尔片浙江益汉制药有限公司 4 CYHS2600597 盐酸奥洛他定片海南万玮制药有限公司 4 CYHS2600595 盐酸氮䓬斯汀滴眼液石家庄凯赛医药科技有限公司 4 CYHS2600594 环硅酸锆钠散杭州仟源保灵药业有限公司 4 CYHS2600593 环硅酸锆钠散杭州仟源保灵药业有限公司 4 CYHS2600592 乙酰半胱氨酸注射液山东新华鲁抗医药有限公司 4 CYHS2600596 乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) 山东见微生物科技有限公司 2 CXSS2600033 德谷胰岛素注射液重庆宸安生物制药有限公司 3.3 CXSS2600034 静注人免疫球蛋白贵州泰邦生物制品有限公司 3.2 CXSL2600302 特立帕肽注射液亿帆医药(上海)有限公司 3.3 CXSL2600294 古塞奇尤单抗注射液正大天晴药业集团南京顺欣制药有限公司 3.3 CXSL2600293 人凝血因子IX 深圳市卫光生物制品股份有限公司 3.4 CXSL2600307 进口申请药品名称企业注册分类受理号贝组替凡片 MERCK SHARP & DOHME (UK) LIMITED 2.4 JXHS2600030 帕博利珠单抗注射液 MSD International Business GmbH 2.2 JXSS2600020 来瑞奇珠单抗注射液 Eli Lilly and Company 3.1 JXSS2600014 司美格鲁肽注射液 Novo Nordisk A/S 3.1 JXSS2600019 司美格鲁肽注射液 Novo Nordisk A/S 3.1 JXSS2600018 司美格鲁肽注射液 Novo Nordisk A/S 3.1 JXSS2600017 司美格鲁肽注射液 Novo Nordisk A/S 3.1 JXSS2600016 司美格鲁肽注射液 Novo Nordisk A/S 3.1 JXSS2600015 巴瑞替尼片 MSN LABORATORIES PRIVATE LIMITED 5.2 JYHS2600005 巴瑞替尼片 MSN LABORATORIES PRIVATE LIMITED 5.2 JYHS2600004 LY4395089片 Eli Lilly and Company 1 JXHL2600079 LY4395089片 Eli Lilly and Company 1 JXHL2600078 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600077 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600076 SNV1521片 Synnovation Therapeutics, Inc. 1 JXHL2600075 SNV1521片 Synnovation Therapeutics, Inc. 1 JXHL2600074 SNV1521片 Synnovation Therapeutics, Inc. 1 JXHL2600073 PF-08653944注射液 Pfizer Inc. 1 JXHL2600072 Pasritamig注射液 Janssen Research & Development, LLC 1 JXSL2600068 Pasritamig注射液 Janssen Research & Development, LLC 1 JXSL2600067 JNJ-87189401 注射液 Janssen Research & Development, LLC 1 JXSL2600066 JNJ-87189401 注射液 Janssen Research & Development, LLC 1 JXSL2600065 Mirikizumab注射液 Eli Lilly and Company 2.2 JXSL2600064 Mirikizumab注射液 Eli Lilly and Company 2.2 JXSL2600063 Mirikizumab注射液 Eli Lilly and Company 2.2 JXSL2600062 尘螨变应原舌下片(Actair) STALLERGENES 3.1 JXSL2600061 尘螨变应原舌下片(Actair) STALLERGENES 3.1 JXSL2600060 中药相关申请药品名称企业注册分类受理号桃红四物汤颗粒上海凯宝药业股份有限公司 3.1 CXZS2600016 小儿健脾消食颗粒山东汉方制药股份有限公司 1.1 CXZL2600026 灵草舒筋酊上海守正中医药研究有限公司 1.1 CXZL2600025 注：绿色字体部分为潜在首仿品种；咸达数据2026年1月每月药讯已出！关注“咸达数据”，微信关键词回复 ” 年+月，如202601” 获得最新药迅！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。

疫苗申请上市临床申请

2026-03-03

·普利制药

【招商】“双重检验”获官方认可——安徽普利药业收到钆布醇原料药《药品GMP符合性检查告知书》

安徽普利药业收到钆布醇原料药《药品GMP符合性检查告知书》 INVESTMENT PROMOTION 诚邀合作，共赢未来 ▸2026 近日，海南普利制药股份有限公司（以下简称“公司”）全资子公司安徽普利药业有限公司（以下简称“安徽普利”）收到安徽省药品监督管理局颁发的《药品GMP符合性检查告知书》，所涉产品为：原料药（钆布醇）。本次钆布醇现场检查于2025年12月进行，采用依申请与依职责合并模式——在钆布醇GMP符合性检查基础上，专家组同步对氢氧化镁、环磷酰胺、钆特酸葡胺三个品种开展了常规GMP符合性检查，合并检查的结论均为“符合要求”。本次《药品GMP符合性检查告知书》的获得，表明安徽普利钆布醇原料药产品及生产线满足GMP要求，这不仅是对12月那次高强度检查的官方认可，更是对公司质量管理体系的权威背书。 1 普利制药钆布醇原料药优势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。市场数据：全球钆布醇需求持续增长根据最新市场数据显示，截至2025年9月的12个月内，全球钆布醇原料API消耗量已达 81.65吨，同比增长 8.1%，市场需求持续扩大。从区域消耗分布看，美国、欧洲等市场是钆布醇的核心消耗区域。其中：美国：25.5吨（占比 31.2%）、其他欧洲地区（含土耳其等）：24.9吨（占比 30.5%）、欧盟五国：9.6吨（占比 11.7%）；至此，安徽普利钆布醇原料药已获得中国、美国、欧盟、土耳其等核心市场的准入资格，覆盖全球绝大多数主流市场。普利制药不仅实现了原料药的全球布局，其制剂产品同样在国际市场取得重大突破。钆布醇注射液属于普利制药的原料制剂一体化品种，其原料来自海南普利制药股份有限公司子公司安徽普利药业有限公司。普利制药的钆布醇注射液已于2023年3月成功获得美国食品药品监督管理局（FDA）的上市许可（ANDA号：217480）。安徽普利钆布醇原料药在中美欧等市场的原料药备案/登记情况： ①US DMF号为039149（状态：A ；已收到正式批准信）; ②CN登记号为Y20240000083，(状态: A ；已批准在上市制剂使用）； ③CEP证书号：CEP 2024-082- Rev 00； ④获得出口欧盟原料药证明文件（WC证书），获得土耳其市场的入场资格。 2 关于安徽普利安徽普利药业有限公司，成立于2018年，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。安徽普利药业拥有强大高效的研发和生产团队、配备现代化生产设施、建立严格地欧美高端原料药cGMP质量体系和高标准EHS体系，为客户提供高品质原料药和中间体的同时，也提供CDMO、工艺技改等。公司目前拥有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、依克多因、红景天苷）、抗肿瘤（环磷酰胺）、其他原料药（氢氧化镁、阿普斯特、克立硼罗、伏立康唑、盐酸美金刚）、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）等系列产品的商业化研发与生产。欢迎垂询，欢迎合作！业务联系：lisubin@hnpoly.com <<< END >>>

上市批准申请上市引进/卖出

2026-03-02

·普利制药

擂响“开春战鼓” 筑牢安全基石——安徽普利药业有限公司启动2026年复工复产工作

擂响“开春战鼓” 筑牢“安全基石” 安徽普利药业有限公司启动2026年复工复产工作人勤春来早，奋进正当时。2026年2月26日新春开工当天，为确保全年生产任务“开门稳、开门红”，安徽普利迅速从“假期模式”切换至“战斗模式”，组织了节后复工复产专题培训，拉开了新一年高质量发展的序幕。收心归位，紧绷“安全弦” 复工复产的第一要务即是安全生产。在培训动员大会上，强调全体员工要迅速收心归位，坚决杜绝“节后综合症”，以“时时放心不下”的责任感，把安全规程落实到每一个操作细节中。精准培训，上好“第一课” 在培训环节，公司EHS部重点重温了《职业健康管理规程》、《特殊作业管理制度》、《安全生产法解读》、《环保法律法规》以及各类消防的应急处置措施、方案等。并通过近期行业典型事故案例分析，让员工直观感受违规操作带来的严重后果，提升员工安全意识和知识技能，确保员工思想返岗、状态在岗、能力适岗。设备体检，排查“零死角” 培训结束后，公司组织开展了全覆盖式的复工复产安全隐患大排查。由公司高层领导带队，对生产车间、综合仓库、污水站等区域以及相关消防设备设施进行了“地毯式”排查,坚决做到“隐患不消除不复产，措施不落实不复产”。蓄势待发，奋战“新篇章” 2026年是公司转型的关键之年。通过此次扎实的复工复产培训和准备工作，不仅强化了全体员工的安全红线意识，更为新一年的高效生产、精益制造奠定了坚实基础。全体安徽普利人正以昂扬的斗志，擂响奋进的战鼓，全力冲刺第一季度“开门红”，为全年目标的实现开好局、起好步。关于安徽普利药业安徽普利药业有限公司，成立于2018年，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。安徽普利药业拥有强大高效的研发和生产团队、配备现代化生产设施、建立严格地欧美高端原料药cGMP质量体系和高标准EHS体系，为客户提供高品质原料药和中间体的同时，也提供CDMO、工艺技改等。公司目前拥有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、依克多因、红景天苷）、抗肿瘤（环磷酰胺）、其他原料药（氢氧化镁、阿普斯特、克立硼罗、伏立康唑、盐酸美金刚）、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）等系列产品的商业化研发与生产。欢迎垂询，欢迎合作！业务联系：lisubin@hnpoly.com = END =

100 项与钆特醇相关的药物交易

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