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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451

项与钆特醇相关的文献（医药）

2024-12-01·Journal of Neurosurgery

Preclinical evaluation of transaxial intraputaminal trajectory for enhanced distribution of grafted cells in Parkinson’s disease

Article

作者: Tran, Ha ; Bratt-Leal, Andres M. ; Mancinelli, Anthony ; Emborg, Marina E. ; Simmons, Heather A. ; Bondarenko, Viktoriya ; Coonen, Jennifer ; Fitz, Casey ; Hurley, Sam ; Larson, Paul ; Menna, Viktorie ; Olsen, Miles ; Metzger, Jeanette M. ; Zinnen, Alexandra D. ; Schultz-Darken, Nancy ; Pape, Bruce ; Wirth, Edward ; Brunner, Kevin ; Colwell, Julia C. ; Fuchs, Kerri

OBJECTIVEThe objective of this study was to develop and evaluate the feasibility and safety of a novel transaxial surgical approach for the delivery of human induced pluripotent stem cell–derived dopaminergic neuroprogenitor cells (DANPCs) into the putamen nucleus using nonhuman primates and surgical techniques and tools relevant to human clinical translation.METHODSNine immunosuppressed, unlesioned adult cynomolgus macaques (4 females, 5 males) received intraputaminal injections of vehicle or DANPCs (0.9 × 105 to 1.1 × 105 cells/µL) under real-time intraoperative MRI guidance. The infusates were combined with 1-mM gadoteridol (for intraoperative MRI visualization) and delivered via two tracks per hemisphere (ventral and dorsal) using a transaxial approach. The total volumes of infusion were 25 µL and 50 µL for the right and left putamen, respectively (infusion rate 2.5 µL/min). Animals were evaluated with a battery of clinical and behavioral outcome measures and euthanized 7 or 30 days postsurgery; full necropsies were performed by a board-certified veterinary pathologist. Brain tissues were collected and processed for immunohistochemistry, including against the human-specific marker STEM121.RESULTSThe optimized surgical technique and tools produced successful targeting of the putamen via the transaxial approach. Intraoperative MR images confirmed on-target intraputaminal injections in all animals. All animals survived to scheduled termination without clinical evidence of neurological deficits. The first 4 animals to undergo surgery had mild brain swelling noted at the end of surgery, of which 3 had transient reduced vision; administration of mannitol therapy and reduced intravenous fluid during the surgical procedure addressed these complications. Immunostaining against STEM121 confirmed the presence of grafted cells along the injection track within the targeted putamen area of DANPC-treated animals. All adverse histological findings were limited in scope and consistent with surgical manipulation, injection procedure, and postsurgical inflammatory response to the mechanical disruption caused by the cannula insertion.CONCLUSIONSThe delivery system, injection procedure, and DANPCs were well tolerated in all animals. Prevention of mild brain swelling by mannitol dosing and reduction of intravenous fluids during surgery allowed visual effects to be avoided. The results of the study established that this novel transaxial approach can be used to correctly and safely target cell injections to the postcommissural putamen and support clinical investigation.

2024-08-01·Journal of Magnetic Resonance Imaging

Efficacy of Whole‐Blood Model of Gadolinium‐Based Contrast Agent Relaxivity in Predicting Vascular MR Signal Intensity In Vivo

Article

作者: Wilson, Gregory J. ; Clark, Toshimasa J. ; Kirchin, Miles A. ; Schneider, Guenther ; Maki, Jeffrey H. ; Norris, Evan C.

BackgroundPrevious in vitro studies have described sub‐linear longitudinal and heightened transverse H2O relaxivities of gadolinium‐based contrast agents (GBCAs) in blood due to their extracellular nature. However, in vivo validation is lacking.PurposeValidate theory describing blood behavior of R1 and R2* in an animal model.Study TypeProspective, animal.Animal ModelSeven swine (54–65 kg).Field Strength/Sequence1.5 T; time‐resolved 3D spoiled gradient‐recalled echo (SPGR) and quantitative Look‐Locker and multi‐echo fast field echo sequences.AssessmentSeven swine were each injected three times with 0.1 mmol/kg intravenous doses of one of three GBCAs: gadoteridol, gadobutrol, and gadobenate dimeglumine. Injections were randomized for rate (1, 2, and 3 mL/s) and order, during which time‐resolved aortic 3D SPGR imaging was performed concurrently with aortic blood sampling via an indwelling catheter. Time‐varying [GBCA] was measured by mass spectrometry of sampled blood. Predicted signal intensity (SI) was determined from a model incorporating sub‐linear R1 and R2* effects (whole‐blood model) and simpler models incorporating linear R1, with and without R2* effects. Predicted SIs were compared to measured aortic SI.Statistical TestsLinear correlation (coefficient of determination, R2) and mean errors were compared across the SI prediction models.ResultsThere was an excellent correlation between predicted and measured SI across all injections and swine when accounting for the non‐linear dependence of R1 and high blood R2* (regression slopes 0.91–1.04, R2 ≥ 0.91). Simplified models (linear R1 with and without R2* effects) showed poorer correlation (slopes 0.67–0.85 and 0.54–0.64 respectively, both R2 ≥ 0.89) and higher averaged mean absolute and mean square errors (128.4 and 177.4 vs. 42.0, respectively, and 5506 and 11,419 vs. 699, respectively).Data ConclusionIncorporating sub‐linear R1 and high first‐pass R2* effects in arterial blood models allows accurate SPGR SI prediction in an in vivo animal model, and might be utilized when modeling MR blood SI.Level of Evidence1Technical EfficacyStage 1

2024-07-01·European Journal of Radiology

Assessment of first-time and repeated acute adverse reactions to gadolinium-based contrast agents in MRI: A retrospective study

Article

作者: Suto, Takayuki ; Ozaki, Daisuke ; Fukushima, Yasuhiro ; Hirasawa, Hiromi ; Tsushima, Yoshito ; Ujita, Koichi ; Taketomi-Takahashi, Ayako

PURPOSETo identify gadolinium-based contrast agents (GBCAs)-related and patient-related risk factors for acute adverse reactions (AARs), and to examine the incidence and severity of repeated AARs.METHODSThis study retrospectively evaluated all intravenous GBCA injections in MRI studies at a single institution from January 2012 to September 2019. First-time AARs in patients without a past history of AARs and risk factors were assessed using multivariable regression models with generalized estimating equations. For patients with a past history of AAR(s), we evaluated the incidence of repeated AARs using the Fisher's exact test, as well as the severity of these repeated AARs.RESULTSFirst-time AARs occurred in 129 of 41,827 GBCA injections (0.31 %; 0.70 % of 18,431 patients). With gadoterate meglumine as the reference, the odds ratio (OR) for allergic-like reactions to three GBCAs ranged from 3.27 to 8.03 (p = 0.012 to <0.001). For chemotoxic reactions, the OR was 3.75 (p = 0.001) for gadoteridol. Outpatients had a lower OR for chemotoxic reactions, while higher ORs were observed in head/neck and breast MRI (p < 0.05). The OR for age was 0.99 (p < 0.05). Patients with a past history of AAR(s) had a 3.6 % incidence of mild repeated AARs for all GBCA, significantly higher than the 0.31 % in first-time AARs (p < 0.001). No effectiveness was found for steroid premedication.CONCLUSIONThe occurrence of first-time AARs was related to the GBCA used and other factors. The incidence of repeated AARs was higher than first-time AARs, though all were mild in severity.

项与钆特醇相关的新闻（医药）

2025-01-20

·普利制药300630

普利制药斩获阿根廷碘帕醇多规格产品亿元人民币合作协议

普利制药斩获阿根廷碘帕醇多规格产品亿元人民币合作协议 2025年1月14日，普利制药迎来了开门红，成功签署阿根廷碘帕醇多规格产品亿元人民币合作协议，不仅为普利制药拓展了阿根廷市场，也标志着其在造影剂领域的国际化战略又迈出了坚实的一步。本次合作标志着普利制药首次在拉美市场取得成果。此前，普利制药的碘帕醇注射液在美国市场已成功签订价值逾亿元的订单。凭借产品的卓越品质与供应的稳定性，普利制药赢得了美国客户的信任，并在国际上树立了良好的声誉。此次阿根廷合作协议的签署，进一步证实了普利制药在国际造影剂市场的竞争力与影响力。 1 阿根廷医药市场阿根廷是拉丁美洲第三经济大经济体，仅次于巴西和墨西哥，在阿根廷，卫生支出约占国内生产总值的9%-10%，属于该地区最高水平之一。霍普金斯大学健康安全中心、核威胁组织和经济学人智库2021年制作的一份对全球195个国家的卫生安全能力的评估报告中指出，阿根廷等拉美国家和世界平均水平相比，其卫生系统更加健全充沛。这也将有利于生物医药产业的发展。 2021年拉美主要国家卫生安全保障指数（数据来源：霍普金斯大学健康安全中心、核威胁组织和经济学人智库，2022）我国连续10年保持拉美第二大贸易伙伴地位，目前也是是阿根廷第二大贸易伙伴（次于巴西），是阿根廷最大的进口来源国。2022年2月阿根廷正式加入“一带一路”倡议。中国与阿根廷签有1300亿元人民币的货币互换协议。2024年4月以来，阿根廷被允许使用人民币进行同中国的进口贸易结算。此前，普利制药在拉美区域的市场布局较为薄弱，此次与央企携手合作，积极拓展阿根廷国际市场，不仅响应了“一带一路”高质量发展的号召，也是普利制药国际化战略部署的重要一步。普利制药期望以此为契机，以阿根廷为起点，全面发力拉丁美洲医药市场，实现更广泛的市场覆盖和更深层次的发展。 2 欧美GMP，规格全面，原料制剂一体化碘帕醇注射液作为一种在医学影像领域广泛应用的造影剂，主要用于CT扫描和血管造影等诊断程序。凭借其生产线符合欧美GMP标准以及11种规格的碘帕醇注射液产品设计和原料制剂一体化的供应链优势，普利制药成功赢得了阿根廷客户的青睐。阿根廷药监部门认可美国GMP或欧洲GMP，普利制药的生产线符合美国、欧盟、中国GMP要求，能够完全满足合作要求。普利制药共研发了11种规格的碘帕醇注射液，与原研企业博莱科公司美国规格一致，使用无需稀释，满足全方位的临床检查需求，在国际规模化订单上具有优势。普利制药全资子公司安徽普利药业同步开发了碘帕醇原料，原料制剂一体化不受上游原料药供应的限制，具有较强的市场竞争力。普利制药的碘帕醇注射液共有11个规格 3 普利制药普利制药拥有包含钆特酸葡胺、钆特醇、钆布醇、碘美普尔、碘普罗胺、碘佛醇、碘帕醇、碘克沙醇等多个的造影剂产品，并且均贯彻原料制剂一体化策略，品种相继上市美国、欧洲、中国市场。已经实现碘帕醇注射液、钆特酸葡胺注射液的中国获批；碘帕醇注射液、钆特酸葡胺注射液、钆布醇注射液的美国获批和钆布醇注射液的荷兰获批。未来，普利制药将一如既往地实施“先进高端制造, 立足国内，面向国际”的战略，持续不断地开发更多更好的药物供应全球，为民族医药工业的壮大持续作出贡献。欢迎国内外朋友、客户洽谈 CRO+CDMO/CMO+CSO业务，共赢发展。业务联系人：周先生邮箱：zm@hnpoly.com

医药出海

2025-01-06

·米内网

【聚焦】16亿注射剂，科伦获批了

精彩内容日前，国家药监局官网显示，科伦药业2款仿制药同日获批生产并视同过评，其中氯维地平乳状注射液为国内第2家获批，碘普罗胺注射液2023年在中国公立医疗机构终端的销售额超过16亿元。氯维地平乳状注射液是阿斯利康开发的一款超短效钙通道阻滞剂，原研产品暂未进入国内市场。南京优科制药的产品于2024年6月获批生产，为国内首家；科伦药业紧接在后，国内第2家获批。此外，扬子江、石药、齐鲁、上海医药的产品报产在审。在心脑血管系统领域，科伦药业已有多个产品获批，其中己酮可可碱注射液、沙库巴曲缬沙坦钠片、盐酸乌拉地尔注射液、丁酸氯维地平脂肪乳注射液等产品视同过评。碘普罗胺注射液是一款造影剂，可用于CT增强，动脉造影和静脉造影，静脉尿路造影，内窥镜逆行胰胆管造影(ERCP)，关节腔造影和其他体腔检查等，不能在鞘内使用。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）终端碘普罗胺注射液销售额超过16亿元，2024上半年有所回落，原研厂家拜耳主导市场。近年来中国公立医疗机构终端碘普罗胺注射液销售情况（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碘普罗胺注射液是科伦药业获批生产并视同过评的第5款造影剂，此前获批的产品分别为碘帕醇注射液、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，2024年科伦药业（含联营公司）有2款1类新药首次获批上市，分别为TROP2 ADC药物注射用芦康沙妥珠单抗、抗PD-L1单抗塔戈利单抗注射液；有42个品种过评或视同过评，其中27个品种以新注册分类报产获批而视同过评，15个品种以补充申请方式过评。27个品种中，ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液、注射用美罗培南/氯化钠注射液、ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液、艾曲泊帕乙醇胺片等为国内首仿（含剂型首仿）。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2025年1月6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 【分享、点赞、在看】点一点不失联哦

上市批准抗体药物偶联物

2025-01-01

·普利制药300630

【普惠天下利泽健康】普利制药2024年度回顾

往昔已展千重锦明朝更进百尺竿 ——普利制药2024满载嘉绩岁末之际，回望不平凡的2024，普利制药犹如一棵坚韧的大树，在风雨中扎根向上！这一路，我们化危机、闯难关，面对医药政策变革背景下带来的改变，荆棘和硕果并存，挑战与机遇并进。这一年，普利上下坚韧不拔、砥砺前行，在挑战中寻找机遇，于困境中谋求发展。每一次创新突破，都是对健康的执着追求；每一次团队协作，都汇聚成前行的强大力量。让我们一同回顾这一年，铭记坚韧向上的每一步，携手迈向更加辉煌的未来！ 1 新品篇 2024年，普利制药在全球范围内取得了显著的制剂及原辅料批件成果，在制剂方面，中国新增27个批件，美国新增14个批件，欧洲新增17个批件，中东及其他国家新增11个批件；在原辅料方面，中国新增6张证书，美国新增4张证书，欧洲新增4张证书，沙特阿拉伯、南非、马来西亚各新增1张证书。这些批件的获得不仅展示了普利制药强大的研发和生产能力，也标志着公司在全球医药市场上的影响力进一步扩大！详见文章如下：【2024年普利制药新增国内批件27个】【新年又一喜报】普利制药尼康普达®尼莫地平注射液获得中国一致性评价批准！【瞩目】中美共线的磷酸奥司他韦胶囊国内获批上市！【喜讯】中外共线的注射用盐酸万古霉素国内获批上市！首家过评：普利制药马来酸曲美布汀片首个通过一致性评价且唯一出口【普利制药第二个国内造影剂】普利制药钆特酸葡胺注射液获得中国注册批件！中美共线生产，原料制剂一体化【喜讯】中美双报的泊沙康唑注射液获国家药品监督管理局NMPA批准上市！【喜讯】可精准给药的磷酸奥司他韦干混悬剂（瓶装）获国家药品监督管理局NMPA批准上市！【新品招商】普利制药别嘌醇片（痛风一线治疗药物）获国家药品监督管理局NMPA批准上市！【普利制药招商】中美双报的注射用替加环素国内获批上市！该药已在多国申报注册，欢迎垂询合作！【新品上市】普利抗过敏赛道新增重磅产品-普利制药富马酸卢帕他定片获国家药品监督管理局批准上市！【首家获批】左亚叶酸钙注射液首家获国家药品监督管理局批准上市，开创普利制药国内抗肿瘤药领域新局面！【普利新品上市】抗心律失常TOP1品种-普利制药胺碘酮注射液获国家药品监督管理局批准上市！【普利新品上市】泌尿赛道新增重磅产品-普利制药赛洛多辛胶囊获国家药品监督管理局批准上市【普利新品上市】中美双报品种，抗支原体感染经典用药-普利制药注射用盐酸多西环素获国家药品监督管理局批准上市【2024年普利制药新增美国批件14个】【普利开门红】2024年第一张ANDA来了——普利舒伏®伏立康唑干混悬剂获得美国FDA上市许可！【喜报】新年第二张美国ANDA批件：普利制药阿昔洛韦钠注射液获美国FDA上市许可！【龙年头筹，今年第3张ANDA】普利制药拉考沙胺注射液获得美国上市许可！【2024年第4张美国ANDA】普利制药布立西坦注射液获得美国暂时性批准！【2024年第5张美国ANDA】普利制药苯磺顺阿曲库铵注射液获得美国上市许可！【2024年第6张美国ANDA】普利制药盐酸去氧肾上腺素注射液获得美国上市许可【喜讯】普利制药碘帕醇注射液7个新品规再获美国FDA上市批准！11个规格全覆盖，全面满足美国临床需求，带来巨大市场机会！【普利制药2024年第8个美国ANDA】规格全覆盖！原料制剂一体化！造影剂钆特酸葡胺注射液获得美国上市许可【普利制药2024年第9个美国ANDA】注射用盐酸多西环素获得美国上市许可，同时已收获第一笔订单! 【招商·美国第十一张ANDA】普利制药布立西坦片获得美国暂时性批准！【招商·美国第十二张ANDA】普利制药新规格苯磺顺阿曲库铵注射液获得美国上市许可【招商·2024年美国第十三张ANDA】普利制药盐酸胺碘酮注射液美国上市招商【招商·2024年美国第14张ANDA】普利制药-注射用环磷酰胺获美国食品药品监督管理局（FDA）上市许可【2024年普利制药新增欧洲批件17个】普利制药2024年第18张国际批件，改良新药伏立康唑注射液获丹麦上市许可！普利制药伏立康唑注射剂型已获批国家市场份额超全球65% 【改良型新药招商：普利制药的伏立康唑注射液欧洲多国获批】诚邀共识之士共同开拓欧洲与全球市场【喜报】普利制药硝普钠注射液获得德国上市许可！【喜讯】普利制药注射用盐酸万古霉素获得英国药品和健康产品管理局上市许可，至此普利制药已获得该品种全球66%以上市场的准入资格【战略合作招商】普利制药注射用盐酸万古霉素获奥地利、德国批准通知，进一步扩大万古霉素国际市场准入资格！【国际招商】喜讯连连！普利制药特利加压素注射液同时获英国、澳大利亚上市许可！【普利制药招商】普利制药多国获批的注射用泮托拉唑钠获波斯尼亚和黑塞哥维那上市许可！【2024年普利制药新增中东及其他国家批件11个】瞩目：普利制药多国获批的注射用泮托拉唑钠获以色列上市许可！【普利制药招商】普利制药多国获批的注射用泮托拉唑钠获阿联酋上市许可！【2024开年第三张海外批件】海外市场再增一国：普利制药注射用伏立康唑获得加拿大批准上市！【国际招商】普利制药注射用更昔洛韦沙特阿拉伯获批上市! 【喜获沙特第二张批文】普利制药注射用比伐芦定在沙特阿拉伯获批上市! 【国际招商】普利制药注射用亚叶酸钙获得哥斯达黎加卫生部上市许可！【国际招商】喜讯连连！普利制药特利加压素注射液同时获英国、澳大利亚上市许可！【2024年普利制药新增原辅料证书】安徽普利药业钆特酸葡胺原料药DMF通过美国FDA技术审评安徽普利原料药钆特酸葡胺原料药获批上市，年产能可达20吨！【喜讯】安徽普利原料药钆布醇荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！【招商】安徽普利原料药钆特醇国内获批上市，期待与您合作，共赢未来安徽普利抗肿瘤原料药环磷酰胺原料药获批上市，年产能可达10吨！【战略合作招商】安徽普利原料药环磷酰胺喜获CEP证书，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！【喜讯】安徽普利原料药硝普钠荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！【招商】安徽普利原料药盐酸美金刚国内获批上市，期待与您合作，共赢未来安徽普利药用辅料磺丁基倍他环糊精钠喜获CEP证书安徽普利药用辅料磺丁基倍他环糊精钠通过国内关联审评 2 业务篇 2024年，普利制药通过一系列的产品中标、首发出口、战略合作与市场拓展及参与国际国内重要展会，不仅提升了自身的品牌影响力，也为全球健康事业做出了积极贡献。特别是在欧美和非洲等市场的成功布局，体现了公司“先进高端制造，面向国内国际”的全球战略正在稳步推进！在集采中标方面，普利制药的钆特酸葡胺注射液和泊沙康唑注射液在第十批国家集采中双双中标，进一步巩固了公司在国内市场的地位。此外，高品质国际化注射用盐酸万古霉素在重庆联盟接续采购中中标，展现了公司在抗生素领域的技术实力。产品首发出口成为普利制药2024年的亮点之一。浙江普利（海南普利全资子公司）生产的阿奇霉素干混悬剂、氟康唑干混悬剂、伏立康唑干混悬剂首次出口美国，标志着公司在国际高端市场上的突破。磷酸奥司他韦胶囊和盐酸胺碘酮注射液也分别在美国实现了首次出口，后者更是实现了浙江普利针剂出口美国零的突破。地氯雷他定片在德国市场表现优异，稳居市占率第二，为国际业绩增长注入新动力。马来酸曲美布汀片首次出口加拿大，拓展了公司在北美的市场布局。碘帕醇注射液在美国市场斩获亿元大单，进一步提升了公司在影像诊断领域的市场份额。在战略合作与市场拓展方面，普利制药与美国主要GPO自有品牌就注射用更昔洛韦达成了长达7年的战略合作，进一步拓宽了美国市场，增强了公司的长期竞争力。同时，普利制药的多国获批产品如注射用泮托拉唑钠已斩获700万支订单并持续接单中，显示了公司在国际市场上的强劲需求。普利制药积极参与国内外重要展会和学术会议，提升了品牌影响力。公司参加了第88届全国药品交易会、第二十二届世界制药原料中国展（CPHI）、PDI'2024注射剂工业大会以及2024年CPhi Milan展会，展示了最新的产品和技术，吸引了众多业内关注。特别是PDI'2024注射剂工业大会上，普利制药的美国获批成绩备受瞩目，彰显了公司在注射剂领域的国际领先水平。详见文章如下：【瞩目】Atome 携手普利制药产品中标比尔&梅琳达·盖茨基金项目，为非洲多国供应精准给药的（瓶装）阿奇霉素干混悬剂！【瞩目】浙江普利（海南普利（300630）全资子公司）制造的阿奇霉素和氟康唑干混悬剂，首发美国【普利“质”造，出口好药】中标比尔&梅琳达·盖茨基金项目，普利舒奇®阿奇霉素干混悬剂（瓶装）首发出口非洲！【瞩目】普利制药地氯雷他定片在德国市场杀出重围，稳居市占率第二，为国际业绩增长注入新动力！【深耕】普利制药多国获批的注射用泮托拉唑钠已斩获700万支订单并持续接单中！【重磅】普利制药碘帕醇注射液美国市场近日斩获亿元大单【喜讯】普利制药马来酸曲美布汀片首次出口加拿大！【瞩目】浙江普利（海南普利（300630）全资子公司）生产的伏立康唑干混悬剂首发美国！【瞩目】普利制药与美国主要GPO自有品牌就注射用更昔洛韦达成长达7年战略合作，将进一步拓宽美国市场【瞩目】浙江普利（海南普利（300630）全资子公司）制造的阿奇霉素和氟康唑干混悬剂，首发美国【出口好药，普利“质”造】普利奥维®磷酸奥司他韦胶囊首发出口美国！【普利新品首发美国】盐酸胺碘酮注射液首发出口美国，浙江普利实现针剂出口美国零的突破！【十批双双中标】普利制药的钆特酸葡胺注射液、泊沙康唑注射液第十批国家集采双双中标！持续亮相！普利舒伏®伏立康唑干混悬剂参展药学、血液、呼吸等多领域学术会议【战略合作招商】高品质国际化注射用盐酸万古霉素重庆联盟接续采购中标！普利制药API展会之旅：创新引领，品质见证｜安徽普利闪耀亮相API China 西安安徽普利2024·上海API China圆满落幕【行业盛会】普利制药第88届全国药品交易会圆满收官，期待下次再聚！普利制药亮相PDI'2024注射剂工业大会，美国获批成绩备受瞩目【行业盛会】安徽普利第二十二届世界制药原料中国展CPHI圆满收官，期待下次再聚！品质铸就国际信任，海外征程-普利一直在路上｜普利制药闪耀亮相2024 CPhi Milan 3 创新药篇 2024年，普利制药通过自主研发和战略合作，在创新药领域取得了多项重要突破。从胰腺癌纳米创新药的核心专利获奖，到获得国内首张造影剂创新药临床批件，再到多个创新药项目的顺利推进，普利制药不仅展示了在药物研发上的创新能力，还通过CDMO服务和国际合作，进一步巩固了公司在全球医药市场中的地位。抗肿瘤纳米创新药：普利制药与浙江大学合作创制的抗肿瘤纳米创新药PLAT001核心专利荣获海南省专利优秀奖。已于今年7月获得中国药物临床试验批准通知书，这一成果体现了公司在肿瘤治疗领域的重大进展，并于今年1月获得美国FDA临床试验批件，标志着我国自主研发的首个在美国获批临床试验的纳米药物，为癌症的治疗带来了新的希望。造影剂创新药：普利制药获得了国内首张造影剂创新药临床批件，注射用PL002获中国药物临床试验批准。这款双模态造影剂旨在弥补现有荧光染料的短板，提升手术精确性，降低手术风险，是全球首个获批临床试验的荧光/磁共振双模态造影剂。抗肿瘤硼中子创新药：普利制药的505(b)(2)抗肿瘤硼中子创新药——注射用硼[10B]法仑的国内临床试验申请获得受理。这一项目与国家重点项目紧密挂钩，旨在推动硼中子俘获疗法（BNCT）的发展，为恶性晚期肿瘤的治疗提供新的选择。 CDMO服务：普利制药与美国一家领先的创新药企Imunon,Inc.,展开了一项深入的合作，助力CDMO的一种新型免疫疗法药物，用于卵巢癌的治疗，并且在Ⅱ期临床试验中取得了令人鼓舞的成果。公司通过提供高质量的合同开发和生产组织（CDMO）服务，帮助合作伙伴加速药物研发进程，展示了公司在CDMO领域的卓越能力。同时，普利制药与宁丹新药签署了创新药临床研究阶段CMO合作协议、与诺宇生物签署创新药CDMO合作协议，与奥赛瑞达成签署铁纳米磁共振造影剂IND阶段的研发合作，进一步拓展了公司在CDMO业务中的合作网络。详见文章如下：普利制药与浙江大学合作创制的胰腺癌纳米创新药PLAT001核心专利荣获海南省专利优秀奖【普利第一张国内造影剂创新药临床批件】普利制药创新药注射用PL002获得中国药物临床试验批准【喜报】普利制药纳米创新药PLAT001获得中国药物临床试验批准通知书【喜讯】普利制药505(b)(2) 抗肿瘤硼中子创新药——注射用硼[10B]法仑国内临床试验申请获得受理【喜讯】普利制药助力CDMO的免疫疗法创新药取得可喜成果，离全面商业化更进一步！普利制药-宁丹新药签署创新药临床研究阶段CMO合作协议普利制药-诺宇生物签署创新药CDMO合作协议【重磅】普利制药与美国知名新药公司合作的创新药械组合项目进展顺利，并已被FDA授予突破性疗法认证普利制药-奥赛瑞签署铁纳米磁共振造影剂IND阶段的研发合作 4 荣誉篇 2024年，普利制药在研发创新、环保责任和公益贡献方面取得了卓越成就，彰显了公司在医药行业的领导地位和社会责任感。在研发创新方面，普利制药荣登“2024中国药品研发综合实力100强”和“2024中国化药研发实力50强”，并在2023年入选“中国医药工业百强榜”。公司与浙江大学合作创制的胰腺癌纳米创新药PLAT001核心专利荣获海南省专利优秀奖，展示了普利制药在前沿药物研发上的突破。地氯雷他定品牌——芙必叮®连续七次荣列“中国医药•品牌榜”，巩固了芙必叮品牌在抗过敏药物市场的领先地位。在公益贡献方面，普利制药积极履行社会责任，展现了企业的公益精神。公司董事长范敏华携企业向美国药典捐赠钆特酸葡胺原料药标准，为全球医药标准的制定做出了贡献。普利制药还荣膺全国生物医药企业平台理事单位，积极参与行业交流和合作，推动医药行业的健康发展。此外，“POLY”商标入选国家首批“千企百城”商标品牌价值提升行动名单，提升了公司的品牌影响力和社会认可度。在环保责任方面，浙江普利药业有限公司荣获2023年临平区“健康企业”称号，并荣膺“清洁生产”和“节水企业”双荣誉称号，体现了公司在环境保护和资源节约方面的努力。安徽普利被列入2023年（第32批）安徽省企业技术中心名单和2024年安徽省绿色工厂名单，展示了公司在技术创新和绿色制造方面的领先水平。海南普利入选第二批“一线放开、二线管住”试点企业名单，标志着公司在进出口管理和环保合规方面的卓越表现。详见文章如下：【荣膺双榜】普利制药，荣登“2024中国药品研发综合实力100强”和“2024中国化药研发实力50强”！【荣耀时刻】普利制药，荣登“2023年度中国医药工业百强榜”！喜讯！地氯雷他定领导品牌——芙必叮® 连续七次荣列【中国医药•品牌榜】！普利制药与浙江大学合作创制的胰腺癌纳米创新药PLAT001核心专利荣获海南省专利优秀奖【前20强】普利制药荣获CPHI China 医药国际化领军企业奖【喜讯】普利制药荣膺全国生物医药企业平台理事单位! 普利制药董事长范敏华携企业向美国药典捐赠钆特酸葡胺原料药标准！浙江普利药业有限公司荣获2023年临平区“健康企业”称号！喜报| 安徽普利被列入2023年（第32批）安徽省企业技术中心名单安徽普利被列入安徽省绿色工厂（2024年）名单【喜讯】海南普利入选第二批“一线放开、二线管住”试点企业名单普利制药“POLY”商标入选国家首批“千企百城”商标品牌价值提升行动名单【荣膺双榜】浙江普利药业荣获“清洁生产”、“节水企业”双荣誉称号！

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