Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated.
The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.

开始日期2025-04-15

申办/合作机构

The Johns Hopkins University

[+1]

NCT06846853

/ Not yet recruiting临床4期IIT

Gadopiclenol Vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI: a Pilot Study

This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. The study is double-blinded, so neither the participants nor the researchers know which contrast agent is being used during each scan to avoid the bias of results.

开始日期2025-03-01

申办/合作机构

University of Connecticut Health Center

NCT06127810

/ WithdrawnN/A

A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)

The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.
Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection

开始日期2024-12-30

申办/合作机构

Medical University of South Carolina

[+1]

100 项与 Gadopiclenol 相关的临床结果

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100 项与 Gadopiclenol 相关的转化医学

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100 项与 Gadopiclenol 相关的专利（医药）

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项与 Gadopiclenol 相关的文献（医药）

2025-03-01·INVESTIGATIVE RADIOLOGY

Gadopiclenol: A q = 2 Gadolinium-Based MRI Contrast Agent Combining High Stability and Efficacy

Article

作者: Medina, Christelle ; Kattenbeck, Christina ; Boubeguira, Yamina ; Decout, Nathalie ; Factor, Cecile ; Mayer, Jean-Francois ; Strzeminska, Izabela ; Maimouni, Ilham ; Maas, Torben J. ; Dehimi, Anissa ; Laurent, Sophie ; Rousseaux, Olivier ; Henoumont, Celine ; Karst, Uwe ; De Goltstein, Marie-Christine ; Catoen, Sarah ; Bazin, Gwenaelle

Objectives:

Gadopiclenol is a q = 2 pyclen gadolinium-based contrast agent (GBCA) recently approved by the Food and Drug Administration, European Medicines Agency, and other European countries. The aim of this report is to demonstrate its stability in multiple stressed in vitro conditions and in vivo, in rat kidney, while maintaining its higher relaxivity compared with conventional GBCAs on the market.

Materials and Methods:

Both gadopiclenol and its chemical precursor Pi828-Gd were characterized and compared with q = 1 gadolinium (Gd) complexes. The number of water molecules coordinated to the Gd (the hydration number, q) was determined by luminescence. 17O NMR (Nuclear Magnetic Resonance) measurements gave access to the water residence time τM. These parameters were used for the fitting of the nuclear magnetic relaxation dispersion profiles in water. Proton relaxivities of the complexes were determined in different media at 60 MHz (1.4 T), at different pH and temperature. The kinetic inertness was investigated in human serum, acidic media, under zinc competition in the presence of phosphate, and under ligand competition. The in vivo stability was evaluated in rat kidneys 12 months after repeated injections.

Results:

The presence of 2 inner-sphere water molecules per Gd complex was confirmed for both pyclen derivatives. The high relaxivity of the complexes in water is maintained under physiological conditions, even under stressed conditions (ionic media, extreme pH, and temperature), which guarantees their efficiency in a large range of in vivo situations. Gd release from the q = 2 complexes was investigated in different potentially destabilizing conditions. Either no Gd release or a slower one than with “q = 1” stable macrocyclic GBCA (acidic conditions) was observed. Their kinetic inertness was demonstrated in physiological conditions, and the Gd release was below the lower limit of quantification of 0.1 μM after 12 days at 37°C in human serum. It was also demonstrated that gadopiclenol is stable in vivo in rat kidney 12 months after repeated injections.

Conclusions:

Thanks to its optimized structural design, gadopiclenol is a highly stable and effective macrocyclic q = 2 GBCA.

2025-02-01·INVESTIGATIVE RADIOLOGY

Impact of the Novel MRI Contrast Agent Gadopiclenol on Radiotherapy Decision Making in Patients With Brain Metastases

Article

作者: Schmeel, Leonard C. ; Eckl, Miriam ; Ruder, Arne ; Stieler, Florian ; Fleckenstein, Jens ; Giordano, Frank A. ; Koch, David ; Bendszus, Martin ; Feisst, Andreas ; Essig, Marco ; Wenz, Frederik ; Sarria, Gustavo R.

Purpose:

The aim of this study was to assess the effect of gadopiclenol versus gadobenate dimeglumine contrast-enhanced magnetic resonance imaging (MRI) on decision-making between whole-brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) for treatment of brain metastases (BMs).

Methods:

Patients with BMs underwent 2 separate MRI examinations in a double-blind crossover phase IIb comparative study between the MRI contrast agents gadopiclenol and gadobenate dimeglumine, both administered at 0.1 mmol/kg. The imaging data of a single site using identical MRI scanners and protocols were included in this post hoc analysis. Patients with 1 or more BMs in any of both MRIs were subjected to target volume delineation for treatment planning. Two radiation oncologists contoured all visible lesions and decided upon SRS or WBRT, according to the number of metastases. For each patient, SRS or WBRT treatment plans were calculated for both MRIs, considering the gross target volume (GTV) as the contrast-enhancing aspects of the tumor. Mean GTVs and volume of healthy brain exposed to 12 Gy (V12), as well as Dice similarity coefficient scores, were obtained. The Spearman rank (ρ) correlation was additionally calculated for assessing linear differences. Three different expert radiation oncologists blindly rated the contrast enhancement for contouring purposes.

Results:

Thirteen adult patients were included. Gadopiclenol depicted additional BM as compared with gadobenate dimeglumine in 7 patients (54%). Of a total of 63 identified metastatic lesions in both MRI sets, 3 subgroups could be defined: A, 48 (24 pairs) detected equal GTVs visible in both modalities; B, 13 GTVs only visible in the gadopiclenol set (mean ± SD, 0.16 ± 0.37 cm3); and C, 2 GTVs only visible in the gadobenate dimeglumine set (mean ± SD, 0.01 ± 0.01). Treatment indication was changed for 2 (15%) patients, 1 from no treatment to SRS and for 1 from SRS to WBRT. The mean GTVs and brain V12 were comparable between both agents (P = 0.694, P = 0.974). The mean Dice similarity coefficient was 0.70 ± 0.14 (ρ = 0.82). According to the readers, target volume definition was improved in 63.9% of cases (23 of 36 evaluations) with gadopiclenol and 22.2% with gadobenate dimeglumine (8 of 36), whereas equivalence was obtained in 13.9% (5 of 36).

Conclusions:

Gadopiclenol-enhanced MRI improved BM detection and characterization, with a direct impact on radiotherapy treatment decision between WBRT and SRS. Additionally, a more exact target delineation and planning could be performed with gadopiclenol. A prospective evaluation in a larger cohort of patients is required to confirm these findings.

2024-09-01·INVESTIGATIVE RADIOLOGY

Evaluation of the Contrast Enhancement Performance of Gadopiclenol for Magnetic Resonance Angiography in Healthy Rabbits and Pigs

Article

作者: Robert, Philippe ; Wintrebert, Mélody ; Arnould, Laurent ; Serfaty, Jean-Michel ; Adriaensen, Hans ; Hugon, Gaëlle

Objectives:

Unexpected accumulations of gadolinium in various organs were reported after the administration of gadolinium-based contrast agents, making desirable to reduce the dose while maintaining equivalent diagnostic performance. The aim of this study was to evaluate the contrast enhancement performance of high relaxivity gadopiclenol compared with gadoterate meglumine in abdominal contrast-enhanced magnetic resonance angiography (CE-MRA).

Materials and Methods:

In a first study in healthy rabbits, axial 3D gradient echo sequences were applied at 4.7 T to study arterial enhancement as a function of gadopiclenol dose (0.025, 0.05, 0.075, and 0.1 mmol Gd/kg) or gadoterate meglumine at 0.1 mmol Gd/kg (n = 5–6/group). The increase in signal-to-noise ratio (ΔSNR) in the aorta at the first pass was measured and compared. In a second, crossover study in 6 healthy pigs, abdominal CE-MRA sequences were acquired at 3 T with gadopiclenol at 0.05 mmol Gd/kg or gadoterate meglumine at 0.1 mmol Gd/kg at a 1-week interval. Quantitatively on the maximum intensity projection (MIP) images, the mean MIP SNR within the aorta of both groups was compared. Qualitatively, a blinded comparison of the angiograms was performed by an experienced radiologist to determine the preferred contrast agent.

Results:

In the rabbit, ∆SNR is linearly correlated with the gadopiclenol dose (P = 0.0010). Compared with gadoterate meglumine 0.1 mmol Gd/kg, an increase in the ∆SNR is observed after 0.05, 0.075, and 0.1 mmol Gd/kg of gadopiclenol (+63% P = 0.0731, +78% P = 0.0081, and +72% P = 0.0773, respectively), whereas at 0.025 mmol Gd/kg, ∆SNR is in the same range as with gadoterate meglumine 0.1 mmol Gd/kg (+15% P > 0.9999). In pigs, contrast enhancement after gadopiclenol at 0.05 mmol/kg is +22% superior to MIP SNR after gadoterate meglumine at 0.1 mmol Gd/kg (P = 0.3095). Qualitatively, a preference was shown for gadopiclenol images (3/6) over the gadoterate meglumine examinations (1/6), with no preference being shown for the remainder (2/6).

Conclusions:

First-pass CE-MRA is feasible with gadopiclenol at 0.05 mmol Gd/kg with at least the same arterial signal enhancement and image quality as gadoterate meglumine at 0.1 mmol Gd/kg.

项与 Gadopiclenol 相关的新闻（医药）

2024-07-25

·GlobeNewswire-Health Care

GUERBET : H1 2024 revenue.

H1 2024 revenue Half-yearly activity H1 revenue: €419.2m, up 11.8% at CER1, including an acceleration in Q2 (+14.5%)This acceleration was driven by continued catch-up in the Americas, the normalisation of orders in France and MRI sales Annual targets confirmed Revenue: expected growth of over 8% like-for-like and at CERProfitability: restated EBITDA margin rate2 higher than in 2021 (14.4%) Villepinte, 25 July 2024, 5.45 pm: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for first-half 2024. As of June 30th, 2024, the Group’s sales totalled €419.2m, up 10.7% compared with the same period in 2023 (€378.6m). Earnings reflected a negative forex effect of €4.1m. At constant exchange rates (CER1), Guerbet’s growth over the first six months was 11.8%. This trend includes an acceleration in the second quarter (+14.5% at CER), following what was already a highly positive momentum in the first quarter (+8.8%). Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 30 June 2024H1 2023*H1 2024% changeH1 2024At CER1% changeSales in EMEA178.5183.4+2.7%182.8+2.4%Sales in the Americas98.6127.3+29.2%127.2+29.1%Sales in Asia101.5108.5+6.8%113.2+11.5%Total378.6419.2+10.7%423.3+11.8% In the EMEA region, Group revenue amounted to €183.4m in the first half, up 2.4% at CER. The decline in the first quarter (-6.2% at CER) was fully offset in the second (+11.0% at CER) as business returned to normal in France after the disruptions linked to the March 1st 2024 reform of the supply circuit for contrast products. Guerbet revenue in the Americas caught up strongly for the third consecutive quarter, with growth of 37.4% in the second quarter at CER, reflecting record production levels at the Raleigh site in North Carolina. Total H1 revenue in the Americas came out at €127.3m, up 29.1% at CER. Asia posted growth of 6.8% over the period, at €108.5m, including a persistent negative currency effect. At CER, growth totalled 11.5% in the first half, despite a slowdown in the second quarter stemming from the contraction in sales in South Korea, where access to care has been paralysed since mid-February by an unprecedented doctor strike. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 30 June 2024H1 2023*H1 2024% changeH1 2024At CER1% changeDiagnostic Imaging 336.5368.8+9.6%372.3+10.7%MRI125.0131.1+4.8%131.5+5.2%X-ray211.4237.7+12.4%240.8+13.9%Interventional Imaging42.250.4+19.5%50.9+20.8%Total378.6419.2+10.7%423.3+11.8% Diagnostic Imaging revenue amounted to €368.8m in H1 2024, up 10.7% at CER. MRI sales increased 5.2% at CER in the first half of the year thanks to a solid performance in the second quarter (+13.5%). Over this period, business was driven by a strong performance by the MRI franchise, and particularly the development of EluciremTM in the United States, together with the initial sales in Germany. X-ray revenue grew 13.9% at CER in H1 2024 as part of a positive business dynamic fuelled by sales of Xenetix® and Optiray®. In Interventional Imaging, revenue at mid-year was up 20.8% at CER. This remarkable performance reflects a strong pick-up in the second quarter (+33.8% at CER) on continued positive momentum for Lipiodol®, in terms both of volumes and prices. Solid visibility for H2 - Confirmation of financial targets for 2024 Having achieved a sustained growth trajectory in the first half of the year, Guerbet enters the second half in full peace of mind. Beyond the catch-up in sales in the Americas, business continues to benefit from firmly established growth drivers firmly across the entire portfolio: in X-rays (Optiray® in particular), Interventional Imaging (strong momentum with Lipiodol®) and the MRI franchise. The latter is now reinforced by the expansion in Europe of EluciremTM, which, after receiving an extremely favourable reception in Germany in Q2 2024, will be launched in in the UK and France in the second half. Guerbet also remains confident in improving its operating profitability, driven by the adjustment of the product mix and price increases, and in its ability to bring cash generation into positive territory. Given these circumstances, the Group is confirming its forecast of sales growth of over 8% in 2024 like-for-like and at CER and expects its adjusted EBITDA margin rate to exceed that of 2021 (14.4%). Free cash flow is expected to be in positive territory for the full year. Next event: Publication of 1st half 2024 results 25 September 2024 after market close About GuerbetAt Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 97 years, with more than 2,920 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, the United States and Israel. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Forward-looking statementsCertain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control. These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.24-0224 on April 3, 2024, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Restated EBITDA margin rate: excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Contacts: Guerbet Jérôme Estampes, Chief Financial Officer +33 1 45 91 50 00 / jerome.estampes@guerbet.comChristine Allard, Head of Communications +33 6 30 11 57 82 / christine.allard@guerbet.com Actifin Marianne Py, Financial Communications +33 1 80 48 25 31 / marianne.py@seitosei-actifin.com Jennifer Jullia, Press +33.1.56.88.11.19 / jennifer.jullia@seitosei-actifin.com Attachment 24 07-25 CP Guerbet CA S1 2024 VDef EN

财报生物类似药

2024-07-08

·信狐药迅

6个潜在3类、4类首仿品种提交上市申请，看看谁家品种？|新受理（7.1-7.7）

本周药品注册受理数据，分门别类呈现，一目了然。(7.1-7.7）新药上市申请无新药临床申请药品名称企业注册分类受理号DX1002片广州安好医药科技有限公司1CXHL2400660DX1002片广州安好医药科技有限公司1CXHL2400659YL-13027片上海璎黎药业有限公司1CXHL2400657YL-13027片上海璎黎药业有限公司1CXHL2400656CB03-154片上海挚盟医药科技有限公司1CXHL2400658ABSK043胶囊上海和誉生物医药科技有限公司1CXHL240065550561片北京卓凯生物技术有限公司1CXHL2400654HRS-2129片山东盛迪医药有限公司1CXHL2400652HRS-2129片山东盛迪医药有限公司1CXHL2400651JRD-018片晶锐医药(苏州)有限公司1CXHL2400648JRD-018片晶锐医药(苏州)有限公司1CXHL2400647IN10018片应世生物科技(上海)有限公司1CXHL2400644IN10018片应世生物科技(上海)有限公司1CXHL2400643吸入用PRT-068四川普锐特药业有限公司2.2CXHL2400646优替德隆注射液成都华昊中天药业有限公司2.4CXHL2400653替比培南匹伏酯细粒剂石药集团中诺药业(石家庄)有限公司3CYHL2400135布洛芬盐酸去氧肾上腺素片北京阳光诺和药物研究股份有限公司3CYHL2400134LY09607南京绿叶制药有限公司2.2;2.3CXHL2400645磷酸氯喹凝胶广州凯普生物科技有限公司2.2;2.4CXHL2400650磷酸氯喹凝胶广州凯普生物科技有限公司2.2;2.4CXHL2400649三价流感病毒裂解疫苗(MDCK细胞)成都欧林生物科技股份有限公司2.2CXSL2400430冻干人用狂犬病疫苗(人二倍体细胞)复星雅立峰(大连)生物制药有限公司3.3CXSL2400431ZL-1218注射液再鼎医药(上海)有限公司1CXSL2400433SDTM001注射液赛德特生物制药有限公司1CXSL2400429重组抗NKG2A人源化单克隆抗体注射液上海怀越生物科技有限公司1CXSL2400427KL-A167注射液四川科伦博泰生物医药股份有限公司1CXSL2400426注射用SKB264四川科伦博泰生物医药股份有限公司1CXSL2400425RJK-RT2831注射液南京融捷康生物科技有限公司1CXSL2400424LTC004北京志道生物科技有限公司1CXSL2400422Obexelimab注射液上海泽纳仕生物科技有限公司1CXSL2400423KYS202004A注射液江苏康缘药业股份有限公司1CXSL2400420HX009注射液杭州翰思生物医药有限公司1CXSL2400419特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSL2400428注射用人生长激素长春生物制品研究所有限责任公司3.3CXSL2400432司美格鲁肽注射液山东新时代药业有限公司3.3CXSL2400421 仿制药申请药品名称企业注册分类受理号普瑞巴林口服溶液浙江赛默制药有限公司3CYHS2402049加替沙星滴眼液海南盈达润泽药业有限公司3CYHS2402038萘普生钠片浙江赛默制药有限公司3CYHS2402037萘普生钠片浙江赛默制药有限公司3CYHS2402036氟哌啶醇片江苏和晨药业有限公司3CYHS2402031阿莫西林克拉维酸钾片(8:1)昆明源瑞制药有限公司3CYHS2402042琥珀酸亚铁片浙江华海药业股份有限公司3CYHS2402039盐酸溴己新注射液河北汇德旭盛医药科技有限公司3CYHS2402018复方醋酸钠林格注射液辰欣药业股份有限公司3CYHS2402017复方醋酸钠林格注射液辰欣药业股份有限公司3CYHS2402016盐酸曲唑酮片重庆圣华曦药业股份有限公司3CYHS2402015乙酰半胱氨酸注射液江苏宝东医药科技有限公司3CYHS2402010地氯雷他定口服溶液北京四环科宝制药股份有限公司3CYHS2402009地氯雷他定口服溶液北京四环科宝制药股份有限公司3CYHS2402008地氯雷他定口服溶液北京四环科宝制药股份有限公司3CYHS2402007依帕司他片安徽省先锋制药有限公司3CYHS2402025己酮可可碱注射液江西泰吉立生物医药科技有限公司3CYHS2402024重酒石酸去甲肾上腺素注射液江西泰吉立生物医药科技有限公司3CYHS2402023维生素K滴剂海南葫芦娃药业集团股份有限公司3CYHS2402022注射用赖氨匹林贵州博林药业有限公司3CYHS2402019布比卡因脂质体注射液江苏恒瑞医药股份有限公司3CYHS2401989注射用塞替派黑龙江福和制药集团股份有限公司3CYHS2402000复合磷酸氢钾注射液亿药通(河北)生物科技有限公司3CYHS2401998枸橼酸托法替布口服液广西维威制药有限公司3CYHS2402004枸橼酸托法替布口服液广西维威制药有限公司3CYHS2402003复方聚乙二醇(3350)电解质口服溶液广西维威制药有限公司3CYHS2402002依帕司他片石家庄康力药业有限公司3CYHS2402001依帕司他片江苏诺泰澳赛诺生物制药股份有限公司3CYHS2401994碳酸氢钠血滤置换液(钾4mmol/L)上海峰林生物科技有限公司3CYHS2401981奥贝胆酸片南京正大天晴制药有限公司3CYHS2401974奥贝胆酸片南京正大天晴制药有限公司3CYHS2401973盐酸甲氧氯普胺注射液四川美大康华康药业有限公司3CYHS2401972维生素K1注射液海南华屹药业有限公司3CYHS2401970氯化钾颗粒涿州东乐制药有限公司3CYHS2401968氯化钾颗粒涿州东乐制药有限公司3CYHS2401967硫酸特布他林口服溶液浙江凯润药业股份有限公司3CYHS2401966舒必利注射液华夏生生药业(北京)有限公司3CYHS2401964别嘌醇片江苏德源药业股份有限公司3CYHS2401963二甲双胍维格列汀片(II)山东朗诺制药有限公司4CYHS2402057乙酰半胱氨酸颗粒郑州韩都药业集团有限公司4CYHS2402056乙酰半胱氨酸颗粒郑州韩都药业集团有限公司4CYHS2402055盐酸达泊西汀片武汉九珑人福药业有限责任公司4CYHS2402054盐酸达泊西汀片武汉九珑人福药业有限责任公司4CYHS2402053依巴斯汀片北京四环科宝制药股份有限公司4CYHS2402052富马酸依美斯汀滴眼液南京恒道医药科技股份有限公司4CYHS2402051富马酸福莫特罗吸入溶液浙江恒研医药科技有限公司4CYHS2402050左氧氟沙星滴眼液广东南国药业有限公司4CYHS2402048西格列汀二甲双胍片(I)北京双鹭药业股份有限公司4CYHS2402047西格列汀二甲双胍片(II)北京双鹭药业股份有限公司4CYHS2402046他达拉非片杭州元素医药有限公司4CYHS2402045他达拉非片杭州元素医药有限公司4CYHS2402044盐酸尼卡地平注射液四川汇宇制药股份有限公司4CYHS2402043地夸磷索钠滴眼液四川美大康华康药业有限公司4CYHS2402032乳果糖口服溶液江西海尔思药业股份有限公司4CYHS2402035乳果糖口服溶液江西海尔思药业股份有限公司4CYHS2402034注射用特利加压素山东如至生物医药科技有限公司4CYHS2402033盐酸达泊西汀片悦康药业集团股份有限公司4CYHS2402041盐酸达泊西汀片悦康药业集团股份有限公司4CYHS2402040头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2402029甲苯磺酸艾多沙班片浙江九洲生物医药有限公司4CYHS2402014甲苯磺酸艾多沙班片浙江九洲生物医药有限公司4CYHS2402013地屈孕酮片浙江赛默制药有限公司4CYHS2402012伏格列波糖片浙江震元制药有限公司4CYHS2402011美沙拉秦栓浙江高跖医药科技股份有限公司4CYHS2402028枸橼酸西地那非片乐普药业股份有限公司4CYHS2402006左卡尼汀注射液浙江北生药业汉生制药有限公司4CYHS2402027枸橼酸西地那非片乐普药业股份有限公司4CYHS2402005维生素B12滴眼液江苏广承药业有限公司4CYHS2402026盐酸尼卡地平注射液华夏生生药业(北京)有限公司4CYHS2402021氢溴酸伏硫西汀片海南倍康医药科技有限公司4CYHS2402030盐酸达泊西汀片杭州元素医药有限公司4CYHS2402020丙戊酸钠缓释片(I)四川科伦药业股份有限公司4CYHS2401997硝苯地平控释片复星医药(徐州)有限公司4CYHS2401999阿戈美拉汀片江苏诺泰澳赛诺生物制药股份有限公司4CYHS2401993盐酸帕洛诺司琼软胶囊昆明积大制药股份有限公司4CYHS2401992氢溴酸伏硫西汀片山西远扬医药科技有限公司4CYHS2401987注射用头孢唑肟钠浙江永宁药业股份有限公司4CYHS2401996注射用头孢唑肟钠浙江永宁药业股份有限公司4CYHS2401995美阿沙坦钾片仁合益康集团有限公司4CYHS2401991美阿沙坦钾片仁合益康集团有限公司4CYHS2401990托拉塞米片浙江诚意药业股份有限公司4CYHS2401988托拉塞米片浙江诚意药业股份有限公司4CYHS2401986亚叶酸钙注射液森淼(山东)药业有限公司4CYHS2401985艾拉莫德片浙江高跖医药科技股份有限公司4CYHS2401984盐酸莫西沙星氯化钠注射液宁波美舒医药科技有限公司4CYHS2401983丙泊酚乳状注射液南京健友生化制药股份有限公司4CYHS2401982吸入用异丙托溴铵溶液南京力成药业有限公司4CYHS2401980吸入用异丙托溴铵溶液南京力成药业有限公司4CYHS2401979维生素B12滴眼液浙江高跖医药科技股份有限公司4CYHS2401978地夸磷索钠滴眼液广州大光制药有限公司4CYHS2401977地夸磷索钠滴眼液广州大光制药有限公司4CYHS2401976盐酸阿莫罗芬搽剂呋欧医药科技(湖州)有限公司4CYHS2401975吗啉硝唑氯化钠注射液西安万隆制药股份有限公司4CYHS2401971莫匹罗星软膏海南海神同洲制药有限公司4CYHS2401969妥布霉素滴眼液山东如至生物医药科技有限公司4CYHS2401965甲苯磺酸索拉非尼片仁合熙德隆药业有限公司4CYHS2401962磷/碳酸氢钠血滤置换液山东齐都药业有限公司4CYHS2401961盐酸戊乙奎醚注射液广州瑞尔医药科技有限公司4CYHS2401960四价重组人乳头瘤病毒疫苗(6,11,16,18型)(汉逊酵母)成都生物制品研究所有限责任公司3.3CXSS2400063 进口申请药品名称企业注册分类受理号阿可替尼胶囊AstraZeneca Pty Ltd.5.1JXHS2400047氢溴酸他泽司他片Epizyme, Inc.5.1JXHS2400046维生素K1混合胶束注射液CHEPLAPHARM Arzneimittel GmbH5.1JXHS2400045二十碳五烯酸乙酯软胶囊Mochida Pharmaceutical CO.,LTD.5.1JXHS2400044古塞奇尤单抗注射液Janssen-Cilag International NV2.2JXSS2400053古塞奇尤单抗注射液Janssen-Cilag International NV2.2JXSS2400052古塞奇尤单抗注射液Janssen-Cilag International NV2.1;2.2JXSS2400054Bleximenib片Janssen Research & Development, LLC1JXHL2400164Bleximenib片Janssen Research & Development, LLC1JXHL2400163Bleximenib片Janssen Research & Development, LLC1JXHL2400162Bleximenib胶囊Janssen Research & Development, LLC1JXHL2400159Bleximenib胶囊Janssen Research & Development, LLC1JXHL2400158Bleximenib胶囊Janssen Research & Development, LLC1JXHL2400157Dexpramipexole片Areteia Therapeutics, Inc.1JXHL2400156Dexpramipexole片Areteia Therapeutics, Inc.1JXHL2400155AZD0780薄膜衣片AstraZeneca AB1JXHL2400151DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400161DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400160注射用68Ga-PSMA-11Telix Pharmaceuticals (US) Inc.2.4JXHL2400154Gadopiclenol注射液Bracco Imaging SPA5.1JXHL2400153Gadopiclenol注射液Bracco Imaging SPA5.1JXHL2400152VGX-3100Inovio Pharmaceuticals, Inc.1JXSL2400119AMG 451Amgen Inc.1JXSL2400118 中药相关申请药品名称企业注册分类受理号易黄颗粒海南葫芦娃药业集团股份有限公司3.1CXZS2400025艾康片安华恒泰(北京)医药科技有限公司1.1CXZL2400037 注：绿色字体部分为潜在首仿品种；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

2024-04-25

·GlobeNewswire-Health Care

Guerbet : Q1 2024 revenue.

Q1 2024 revenue Quarterly activity Revenue: €194.3m, up 8.8% at CER1Growth remains particularly strong in Asia (+26.8% at CER) and the Americas (+20.1% at CER); the EMEA region (-6.2% at CER) was temporarily impacted by the reform of the supply of contrast products in France Annual targets confirmed Revenue: expected growth of over 8% like-for-like and at CERProfitability: restated EBITDA margin rate2 higher than in 2021 (14.4%) Villepinte, 25 April 2024, 5.45 pm: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the first fiscal quarter. At 31 March 2024, the Group’s sales totalled €194.3m, up 7.6% compared with the same period in 2023. Given an unfavourable foreign exchange effect of €2.2m, largely linked to Asian currencies, revenue at CER1 was up 8.8% over the period. Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeSales in EMEA89.083.9-5.8%83.6-6.2%Sales in the Americas47.557.4+21%57.0+20.1%Sales in Asia44.152.9+20%55.9+26.8%Total180.6194.3+7.6%196.5+8.8% *Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. In the EMEA region, the Group generated revenue of €83.9m in the first quarter, down 5.8% (-6.2% at CER) mainly owing to the dip in sales volumes in France. This trend stems directly from the implementation on 1 March 2024 of the reform of the supply circuit for contrast products, which caused difficulties in order intakes with radiologists. The Group expects to largely catch up on the resulting delays in sales in the second quarter of 2024. In the Americas, sales totalled €57.4m, up 21.0% over the period (+20.1% at CER). Sales caught up strongly for the second consecutive quarter following the return to historic production levels at the Raleigh site in North Carolina. Group revenue in Asia was €52.9m, with continued strong growth momentum (+20%) driven by the performances of China, South Korea and Japan. The total includes a negative currency effect (-€3.0m) linked in particular to the further depreciation of the yen. At CER, sales in Asia rose 26.8% in first-quarter 2024, confirming the Group’s ambitions in this region. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeDiagnostic Imaging 160.8173.6+7.9%175.5+9.1%MRI60.758.2-4.1%58.4-3.7%X-ray100.2115.4+15.2%117.1+16.9%Interventional Imaging19.820.7+4.4%21.0+6.1%Total180.6194.3+7.6%196.5+8.8% 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.*Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. Diagnostic Imaging revenue increased 7.9% in Q1 2024 (+9.1% at CER) to €173.6m. MRI activity was down 3.7% at CER. This decline resulted from the postponement of several substantial orders in the MRI franchise (Dotarem® / EluciremTM) in France, all of which will be booked in the second quarter of 2024.X-ray revenue increased 16.9% at CER over the period, a remarkable increase driven by all the division’s products, particularly Xenetix®. In Interventional Imaging, revenue rose 6.1% at CER in Q1 2024 on continued favourable momentum for Lipiodol®, fuelled by volumes and prices alike. All financial targets confirmed for 2024 The highly positive trend overall at the start of the year boosts Guerbet’s confidence for the full year. In a buoyant contrast products market, Group business will be bolstered by the ramp-up of the MRI franchise, growth in Optiray® sales, and continued favourable momentum for Lipiodol®. At the same time, operating profitability will benefit from the change in the product mix and the continued rise in prices, while cash generation will improve considerably, particularly as inventory levels return to normal. Given these circumstances, Guerbet is confirming its forecast of sales growth of over 8% in 2024 like-for-like and at CER and expects its adjusted EBITDA margin rate to exceed that of 2021 (14.4%). Free cash flow is expected to be in positive territory for the full year. Next events : Annual Shareholders' Meeting for fiscal year 202324 May 2024 Publication of 1st half 2024 revenue 25 July 2024 after market close About GuerbetAt Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 97 years, with more than 2,920 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, the United States and Israel. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Forward-looking statementsCertain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control. These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.24-0224 on April 3, 2024, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Restated EBITDA margin rate : excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Attachment CP CA T1 2024_VFinale EN

财报

100 项与 Gadopiclenol 相关的药物交易

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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
造影剂	欧盟	Bracco Imaging SpA	2023-12-11
造影剂	冰岛	Bracco Imaging SpA	2023-12-11
造影剂	列支敦士登	Bracco Imaging SpA	2023-12-11
造影剂	挪威	Bracco Imaging SpA	2023-12-11
诊断试剂	欧盟	Guerbet SA	2023-12-07
诊断试剂	欧盟	Bracco Imaging SpA	2023-12-07
诊断试剂	冰岛	Guerbet SA	2023-12-07
诊断试剂	冰岛	Bracco Imaging SpA	2023-12-07
诊断试剂	列支敦士登	Bracco Imaging SpA	2023-12-07
诊断试剂	列支敦士登	Guerbet SA	2023-12-07
诊断试剂	挪威	Guerbet SA	2023-12-07
诊断试剂	挪威	Bracco Imaging SpA	2023-12-07
中枢神经系统疾病	美国	Guerbet LLC	2022-09-21
血管疾病	美国	Guerbet LLC	2022-09-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
先天性心脏缺损	临床3期	美国	Bracco Imaging SpA	2024-05-01
脑干胶质瘤	临床3期	匈牙利	Guerbet LLC	2023-09-07
脑干胶质瘤	临床3期	意大利	Guerbet LLC	2023-09-07
脑干胶质瘤	临床3期	波兰	Guerbet LLC	2023-09-07
胶质瘤	临床3期	匈牙利	Guerbet LLC	2023-09-07
胶质瘤	临床3期	意大利	Guerbet LLC	2023-09-07
胶质瘤	临床3期	波兰	Guerbet LLC	2023-09-07
血脑屏障缺陷	临床3期	美国	Guerbet LLC	2019-06-03
血脑屏障缺陷	临床3期	比利时	Guerbet LLC	2019-06-03
血脑屏障缺陷	临床3期	法国	Guerbet LLC	2019-06-03

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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


ASCO2024	临床2期	脑转移瘤	13	Gadopiclenol 0.1 mmol/kg	蓋構憲壓醖廠築範鑰壓(壓鏇鑰淵鑰餘齋願醖顧) = 淵壓壓蓋積鑰鏇繭鑰鹽鹹簾糧選衊範鬱鏇鏇網 (製積鹽積齋糧鏇糧鬱壓 ) 更多	积极	2024-05-24
NCT03749252 (CTgov)	临床2期	中枢神经系统疾病	80	P03277 (CNS Cohort 2-6 Years)	遞蓋夢廠網鏇膚壓範鏇(壓構襯鬱網顧鏇鬱襯繭) = 窪選夢鏇觸獵選選餘鏇醖淵齋鏇構鬱憲選壓鹹 (範膚鬱衊獵憲網醖鑰積, 鬱鏇壓構憲蓋淵膚淵簾 ~ 齋製淵鹽繭範積鏇遞簾) 更多	-	2022-06-01
				P03277 (CNS Cohort 7-11 Years)	遞蓋夢廠網鏇膚壓範鏇(壓構襯鬱網顧鏇鬱襯繭) = 鬱鬱築鬱繭窪膚齋鑰齋醖淵齋鏇構鬱憲選壓鹹 (範膚鬱衊獵憲網醖鑰積, 憲廠遞鑰鏇願範衊選範 ~ 願簾築憲壓構蓋築齋壓) 更多
NCT02973516 (CTgov)	临床2期	肝细胞癌 \| 慢性肝病	41	Gadopiclenol (Cohort 1)	鬱衊艱顧獵艱觸憲醖齋 = 膚願壓繭觸製餘鹽齋繭蓋鏇範遞簾鬱獵齋網範 (範齋鬱淵廠衊觸築鹹鏇, 構製齋窪糧顧範鹹積遞 ~ 積網襯遞窪簾襯艱遞醖) 更多	-	2021-10-06
				Gadopiclenol (Cohort 2)	鬱衊艱顧獵艱觸憲醖齋 = 觸膚蓋齋壓構淵齋鹽鏇蓋鏇範遞簾鬱獵齋網範 (範齋鬱淵廠衊觸築鹹鏇, 簾獵網選襯築鬱網壓構 ~ 襯構鹽觸構淵窪選膚糧) 更多
NCT03657784 (Pubmed \| Invest Radiol)	临床1期	肾功能不全	40	Gadopiclenol (Healthy subjects)	淵襯鑰獵範鏇餘夢鑰觸(齋齋鏇鹹築鹹衊窪壓壓) = 簾築窪範簾選範觸顧餘製醖築艱憲窪夢醖獵鏇 (網積選顧醖餘齋鏇窪遞 )	-	2021-08-01
				Gadopiclenol (Subjects with mild renal impairment)	淵襯鑰獵範鏇餘夢鑰觸(齋齋鏇鹹築鹹衊窪壓壓) = 醖廠膚憲襯醖積襯艱衊製醖築艱憲窪夢醖獵鏇 (網積選顧醖餘齋鏇窪遞 )
NCT03996447 \| NCT03986138 (PICTURE \| PROMISE, Corporate Publications) 人工标引	临床3期	造影剂	560	Gadopiclenol+gadobutrol	簾積艱糧窪齋齋簾艱淵(鏇鬱獵蓋範膚壓鑰顧網) = the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied. 構蓋顧鏇鬱窪顧衊鑰夢 (衊範構繭願餘製膚築襯 ) 更多	积极	2021-03-24
				Gadobutrol+Gadopiclenol
NCT03603106 (Pubmed \| Invest Radiol)	临床1期	可见病灶	142	Gadopiclenol	繭積構廠鬱糧觸構襯齋(顧糧築遞餘餘鬱鏇衊顧) = 糧膚獵獵憲齋艱醖選築艱鹹衊製製餘蓋積築鬱 (繭鬱觸憲蓋繭夢艱襯廠 )	-	2019-07-01