Phase IV, single-center, randomized, crossover clinical trial to validate the use of gadopiclenol versus gadobutrol in the evaluation of magnetic resonance imaging (MRI) diagnosis of perianal fistula associated with Crohn's disease

开始日期2025-12-01

申办/合作机构-

CTIS2025-521810-24-00

/ Active, not recruiting临床4期

Pilot study to explore the diagnostic value of gadopiclenol in pathological and radiological insights with multiparametric MRI enhancement in breast cancer.

开始日期2025-09-22

申办/合作机构-

NCT07040865

/ Recruiting临床4期

Randomized, Single-Blind, Monocentric, Non-Inferiority Trial of Gadopiclenol (Vueway®) Contrast Agent Performance vs. Gadobutrol (Gadovist®) in the Workup of Incidental Renal and Adrenal Findings

The purpose of this study is to compare the effects of the contrast agent Gadopiclenol with those of the standard contrast agent Gadobutrol.
The main question of this study is :
Does gadopiclenol offer diagnostic properties that are equally effective as those of gadobutrol?
Participants will be:
* randomly assigned to one of two groups: the experimental group, which receives gadopiclenol, or the control group, which receives gadobutrol. Each participant is informed of their group allocation prior to the magnetic resonance imaging (MRI) scan.
* invited for a single MRI appointment lasting approximately 60 minutes

开始日期2025-08-18

申办/合作机构

Insel Gruppe AG

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）

2025-12-01·Japanese Journal of Radiology

Pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers

Article

作者: Pitrou, Camille ; Taoka, Toshiaki ; Eto, Takashi ; Felices, Mathieu

Abstract:

Purpose:

The aim of this study was to evaluate the pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers. A population-based pharmacokinetic approach was used to compare pharmacokinetic parameters with a non-Japanese adult population.

Materials and methods:

In this double-blind, placebo-controlled phase I study, Japanese healthy volunteers were randomized to receive gadopiclenol (at 0.025, 0.05, or 0.1 mmol/kg) or a placebo. Blood and urine samples were collected up to 24- and 48-h post-administration, respectively. The pharmacokinetic profile of gadopiclenol was evaluated using standard non-compartmental analysis. Adverse events (AEs) were collected during the whole study period.

Results:

Overall, 27 participants were randomized (median [range] age: 22 [20–43] years; 52% male): 18 received gadopiclenol (6 in each dose group), and 9 received the placebo. The mean systemic exposure of gadopiclenol increased proportionally with the injected dose (area under the curve [AUC]: 215–1034 μg/mL.h) and was comparable between the three dose groups when normalized to dose (AUC/dose: 182–189 μg/mL/g.h) and to non-Japanese (168–183 μg/mL.h). The mean terminal half-life (1.43–1.86 h), and the distribution volume (11.3–15.2 L) were also similar to those of non-Japanese healthy volunteers (1.50–1.73 h and 13.0–15.5 L, respectively). The mean fraction of gadopiclenol excreted in urine was between 87 and 95%, depending on the administered dose. Most of gadopiclenol (median of 95.7%) was excreted within 24 h after administration. The mean total clearance was comparable between the different administered doses (5.3–5.6 L/h) and similar to the mean renal clearance. No gadopiclenol-related AEs were reported.

Conclusions:

The pharmacokinetic profile of gadopiclenol is similar in Japanese and non-Japanese healthy volunteers. The population pharmacokinetic analysis showed no significant ethnic disparities between these two populations and suggested that no dose adjustment was required for Japanese patients. Gadopiclenol had a very good tolerability in Japanese healthy volunteers with no adverse reactions reported.

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.

2025-10-01·EUROPEAN JOURNAL OF RADIOLOGY

Gadolinium concentration dependent signal enhancement profiles using routine clinical sequences with gadopiclenol, gadoterate, gadobutrol, and gadoxetate at 1.5, 3 and 7 Tesla

Article

作者: Froehlich, Johannes M ; Nanz, Daniel ; Sutter, Reto ; Marth, Thomas

PURPOSE:

Gadopiclenol, a new gadolinium-(Gd) based contrast agent (GBCA), exhibits a higher longitudinal relaxivity (r₁) than current standard GBCAs, and, thus, has the potential to be used at lower dose or to generate a brighter T1-weighted (T1w) signal at equivalent dose. As the relationship between enhancement and contrast agent concentration is non-linear, the signal profiles should be experimentally explored and compared to those of current GBCAs.

MATERIALS AND METHODS:

Standardized aqueous dilution series (0.0 to 25 mmol/L) of gadopiclenol, and current standard GBCAs gadoterate, gadobutrol, and gadoxetate were imaged with nine clinical sequences at 1.5, 3, and 7 Tesla(T). Signal intensities(SIs) were measured for each concentration and set in relation to the SI of water(rSI). Additionally, T1 relaxation times were measured at 3 T and r₁ was calculated.

RESULTS:

The maximum rSI in T1w fast-spin-echo images was observed at a lower Gd concentration (1.0 mmol/L) at all three field strengths in the gadopiclenol series than in the current standard GBCAs series (gadoterate and gadobutrol, 2.5 mmol/L, all field strengths, gadoxetate, 2.5 mmol/L at 1.5 and 3 T, 1.0 and 2.5 mmol/L at 7 T). The maximum rSI measured at 1.0 mmol/l gadopiclenol was comparable (±12 %rSI) to the rSI at 2.5 mmol/l of standard GBCAs. Molar gadopiclenol relaxivity, r₁, (13.5 ± 1.5 s^-1∙mM^-1) was three to four times higher than r₁ of gadoterate and gadobutrol (3.4 ± 0.4 and 4.1 ± 0.5 s^-1∙mM^-1, respectively), and 2.2 times higher than of that of gadoxetate (6.0 ± 0.7 s^-1∙mM^-1).

CONCLUSION:

Our results confirm the maximum signal intensity in clinical T1w images to be shifted to lower gadolinium concentrations of gadopiclenol compared to standard GBCAs at all field strengths.

项与 Gadopiclenol 相关的新闻（医药）

2025-04-09

·DrugAI

J. Med. Chem. | 机器学习遇上药物动力学，让候选药物“提前亮相”

DRUGAI今天为大家介绍的是来自美国剑桥赛诺菲定量药理学研究负责人Panteleimon D. Mavroudis与Nikhil Pillai团队的一篇论文。这项研究主要关注药物动力学(pharmacokinetic, PK)特征的预测工作。传统预测方法需要通过体外或体内测试获取参数，这些方法不仅耗时耗力，还会涉及伦理问题。为克服这些限制，研究团队开发了基于机器学习（Machine Learning, ML）的数据驱动模型。研究人员从公开数据源收集了大量小分子的物理化学和药物动力学特性数据，并从文献中提取了约800种化合物的人体血浆浓度-时间曲线数据。他们提出了两种创新性的预测框架：一种是将机器学习与生理药代动力学模型相结合的混合框架，另一种是通过两个学习阶段来直接预测药物动力学特征的机器学习框架。在对106种药物的测试中，这些框架展现出优秀的预测性能。在药物血浆浓度-时间曲线下面积（AUC）和最高血药浓度（Cmax）这两个关键指标上，40-60%的化合物预测误差在2倍以内，80-90%的化合物预测误差在5倍以内。这些方法有望提升早期药物筛选和设计效率，推动药物研发能力的进步。药物研发是一个复杂且耗时的过程，其中预测新药在人体内的暴露情况对评估药物的有效性和安全性至关重要。传统的预测方法主要依赖生理药代动力学（Physiological Based PK, PBPK）等数学模型，这些方法需要大量实验室测试和动物实验，不仅成本高昂，还面临效率和伦理问题。图 1为了解决这些挑战，研究团队开发了两种创新性的预测框架（如图1所示）：一种是混合模型框架，它将机器学习与生理药代动力学模型相结合；另一种是分层机器学习框架。这两种框架都采用两步建模策略：第一步都是使用机器学习从化学结构预测药物的物理化学和药代动力学参数。在第二步中，混合框架将这些参数输入PBPK模型进行模拟，而分层框架则将这些预测参数输入另一个机器学习模型，直接预测药物在人体内的浓度变化曲线。为支持这项研究，团队建立了迄今为止最大的人体静脉注射药物数据库，收录了约800种药物的动力学曲线数据。这个庞大的数据库为开发准确的预测模型提供了坚实的基础，有望在药物早期研发阶段就能快速、准确地预测药物在人体内的表现，从而大幅提高新药研发的效率。数据获取图 2研究团队首先通过数字化处理文献中的药物动力学曲线，获得了773种静脉注射药物的数据（如图2所示）。为确保评估的客观性，他们将106种具有完整观测数据的化合物作为测试集，其余667种作为训练集。根据表1显示，训练集包含667种化合物在不同时间点的8715个浓度值，测试集则包含106种化合物的1351个浓度值。研究发现药物动力学参数的原始分布较为不均匀，特别是清除率（CL）和稳态分布容积（VDss）。为了优化模型效果，研究人员将这些值转换为以10为底的对数值。如图3A-E所示，测试集中所有物理化学和药物动力学参数的分布都落在训练集的范围内，这保证了模型预测的可靠性。图 3在参数选择方面，研究团队使用了计算机模拟获得的酸碱解离常数（pKa）和辛醇-水分配系数（logP）值，而不是实验测定值。这是因为在773种药物中，仅有29种具有实验测定的pKa值，83种具有实验测定的logP值，数据覆盖率过低。相比之下，ChEMBL数据库中约570种化合物与这些药物重叠，提供了更全面的计算值数据。研究还发现，计算值与实验值具有良好的相关性，且使用实验测定的logP值并未显著改善预测效果。这种选择不仅提高了数据的可用性，也为未来整合更多实验数据预留了优化空间。构建QSAR模型预测PC/PK参数图 4研究团队开发了定量构效关系（Quantitative Structure-Activity Relationship, QSAR）模型来预测药物的各项参数。他们使用3种机器学习算法和5种分子特征描述方法，共构建了15个独立模型，并通过组合这些模型的预测结果建立了集成模型。图4的热图展示了所有模型在测试集上的预测准确度（R²值）。表 2图 5如表2和图5所示，不同参数的最佳预测模型各不相同：对于药物游离分数（Fu），支持向量机（Support Vector Machine, SVM）算法表现最佳，60%的测试化合物预测误差在2倍范围内；对于药物清除率（CL）和稳态分布容积（VDss），集成模型效果最好，分别有64%和62%的化合物预测误差在2倍范围内；对于酸性解离常数（pKa acidic），极限梯度提升（XGBoost）算法配合RDKit分子描述符的模型最优，98%的测试化合物预测误差在2倍内；对于碱性解离常数（pKa basic），集成模型表现最佳，91%的化合物预测误差在2倍内。研究发现，使用分子结构描述符（如RDKit、Mordred等）训练的模型普遍优于使用分子指纹特征的模型。集成模型通过整合多个单一模型的优势，能够提供更稳定和准确的预测。由于酸碱性参数涉及的机制相对简单，其预测准确度较高。而游离分数、清除率和分布容积的预测则更具挑战性，因为这些参数受到蛋白质相互作用、生物过程和个体差异等多重因素的影响。尽管如此，这些模型的预测误差平均在2倍以内，达到了业界公认的标准，且优于已发表的同类研究成果。混合建模研究研究团队使用生理药代动力学软件PK-Sim开展了混合建模研究。在这个框架中，他们将机器学习预测的药物参数输入到生理药代动力学（PBPK）模型进行模拟。为了评估效果，研究人员还进行了对照实验：使用实验观测到的参数进行PBPK模拟。图 6如图6A所示，在预测药物血浆浓度-时间曲线下面积（AUC）和最高血药浓度（Cmax）时，对照组在2倍误差范围内的准确率更高。但在3倍和5倍误差范围内，混合方法的表现与对照组相当或更优。图 7图7展示了几个典型案例：当物理化学和药代动力学参数的预测误差在2倍以内时，两种方法都能准确预测药物浓度变化曲线；预测效果不佳通常是因为游离分数（Fu）和清除率（CL）预测不准，例如化合物ID 240的清除率预测值比实际值低41倍，导致预测的药物浓度显著偏高；在某些情况下，混合方法反而比使用实验参数的预测更准确，如化合物ID 789和1325的案例。研究还比较了不同药物分布模型的效果。有些药物（如ID 31和72）在各种模型中预测结果相近，而其他药物（如ID 315和461）则因模型选择而差异显著。这是因为不同模型考虑的因素不同，例如有些模型会特别考虑药物的酸碱性与人体pH值的相互作用。考虑到新药机制往往不明确，难以预先确定最适合的分布模型，研究团队采用了多个模型预测结果的平均值。这种平均策略的效果优于单一模型：43%的AUC和39%的Cmax预测误差在2倍以内，80%的AUC和82%的Cmax预测误差在5倍以内。分层ML建模研究研究团队使用667种化合物的数据开发了分层机器学习模型，用于预测药物在不同时间点的浓度。最佳表现来自随机森林（Random Forest, RF）算法，该算法综合考虑了药物的酸碱解离常数、游离分数、清除率、分布容积和给药时间等特征。在106种测试化合物中，55%的浓度预测误差控制在2倍范围内。图 8如图8所示，这种方法在预测药物暴露水平方面表现出色：60%的血药浓度曲线下面积（AUC）和59%的最高血药浓度（Cmax）预测误差在2倍以内，超过90%的预测误差在5倍以内。特别是对于某些复杂案例，如图9中的化合物ID 219和315，分层方法的预测比传统方法更准确。这可能是因为分层方法能够从大量真实数据中学习复杂的药物-人体相互作用模式，而不受预设机制的限制。图 9研究还尝试通过定义模型的适用范围来提高预测准确度，即根据待测化合物与训练集化合物的结构相似度来判断预测的可靠性。但这种方法未能显著改善预测效果，这反映出药物结构与其在体内行为之间的关系十分复杂。当前框架的主要局限在于将每个时间点的浓度预测作为独立任务处理，忽略了浓度随时间变化的连续性。这可能导致预测结果出现不连贯的情况，例如在化合物ID 789、1167和1210的案例中，某些时间点的预测浓度低于后续时间点，这与药物在体内的实际表现不符。这种问题可能源于数据处理误差，也可能反映了模型在捕捉时间序列特征方面的不足。使用最近批准的药物进行外部验证图 10为了进一步验证模型的实用性，研究团队选择了7种FDA在2019-2023年间新批准的药物进行测试。如图10所示，分层机器学习模型展现出优秀的预测能力：所有药物的血药浓度曲线下面积（AUC）和最高血药浓度（Cmax）预测误差都控制在4倍以内，其中4种药物的误差更是在2倍范围内。相比之下，混合方法的表现较差，特别是在预测Abrocitinib和Gadopiclenol时。例如，模型低估了Abrocitinib的清除率（实测：0.722，预测：0.240 L/h/kg），导致预测的药物浓度偏高。这种误差可能源于基础PBPK模型未考虑主动转运体和其他代谢信息。在研究规模和数据质量方面，本研究建立了约800种化合物的人体药物动力学数据库，这是目前同类研究中最大的数据集之一。与其他研究相比，如Geci等人的工作（在5倍误差范围内达到71%的AUC和78%的Cmax预测准确率），本研究的混合建模框架展示了相当的性能。在方法选择上，研究采用了传统的机器学习算法而非复杂的深度学习模型。这是因为临床研究中的药物浓度数据通常采样时间不规则，而循环神经网络（Recurrent Neural Network, RNN）等深度学习模型往往需要均匀采样的数据。虽然神经常微分方程（Neural Ordinary Differential Equation, Neural-ODE）可以处理不规则数据，但这类深度学习方法计算复杂，且在小样本情况下容易过拟合。结论研究团队开发了两种药物动力学预测框架：一种结合机器学习和机制建模的混合框架，另一种直接从分子结构预测药物浓度的分层机器学习框架。在大量公开数据的支持下，两种方法都展现出良好的预测能力，其中分层方法表现更优。本研究利用大量公开的人体药物动力学研究数据，为药物开发提供了新的预测工具。这些模型为未来研究奠定了基础，通过引入更先进的机器学习算法，如科学机器学习方法，可以整合多源信息并从真实世界数据中识别系统特征，有望进一步提高预测准确度。研究的最终目标是帮助制药企业在药物开发早期就能预测候选化合物的药物动力学特征，从而更高效地筛选和优化潜在药物，加速新药研发进程。编译|于洲审稿|王梓旭参考资料Jia X, Teutonico D, Dhakal S, et al. Application of Machine Learning and Mechanistic Modeling to Predict Intravenous Pharmacokinetic Profiles in Humans[J]. Journal of Medicinal Chemistry, 2025.

疫苗

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

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	韩国	-	2026-01-12
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
血管畸形	申请上市	加拿大	Bracco Imaging SpA	2025-04-01
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

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临床结果

适应症

分期

评价

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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


NCT05590884 (CTgov)	临床2期	中枢神经系统疾病	36	Gadopiclenol (Age Group 1: Patients Aged 3 to 23 Months)	艱網願鑰襯壓鹹襯鬱鏇(窪廠鹹簾範餘築鏇遞鹽) = 選範鏇夢範鹽願願膚遞壓醖繭醖範壓簾積壓鹽 (鹽醖廠築獵簾淵範壓鏇, 27.6) 更多	-	2025-10-28
				Gadopiclenol (Age Group 2: Patients Aged 28 Days to Less Than 3 Months)	艱網願鑰襯壓鹹襯鬱鏇(窪廠鹹簾範餘築鏇遞鹽) = 鏇憲壓壓夢淵齋構壓顧壓醖繭醖範壓簾積壓鹽 (鹽醖廠築獵簾淵範壓鏇, 9.9) 更多
NCT03986138 (PROMISE, CTgov)	临床3期	-	324	Gadopiclenol (Patients With Gadopiclenol Paired Images)	鑰製衊顧網顧鹽艱艱築(醖膚廠膚壓選衊鹽簾獵) = 衊艱繭鹽壓鑰壓壓餘鹹襯願鬱齋鹹網顧選鹹廠 (鬱遞齋壓簾壓衊襯蓋窪, 0.03) 更多	-	2025-10-27
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	鑰製衊顧網顧鹽艱艱築(醖膚廠膚壓選衊鹽簾獵) = 製鏇繭窪餘製構蓋衊夢襯願鬱齋鹹網顧選鹹廠 (鬱遞齋壓簾壓衊襯蓋窪, 0.03) 更多
NCT03996447 (PICTURE, CTgov)	临床3期	血脑屏障缺陷	260	Gadopiclenol (Patients With Gadopiclenol Paired Images)	襯艱遞簾膚製鑰鑰壓願(鹹鹽窪鑰製範顧淵糧鏇) = 構醖觸憲廠構餘觸鹹鑰壓鏇顧網顧憲糧艱憲鑰 (顧遞簾鏇繭遞夢顧窪蓋, 0.02) 更多	-	2025-09-22
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	襯艱遞簾膚製鑰鑰壓願(鹹鹽窪鑰製範顧淵糧鏇) = 淵遞網構積糧餘顧構淵壓鏇顧網顧憲糧艱憲鑰 (顧遞簾鏇繭遞夢顧窪蓋, 0.02) 更多
phase IIb study (ASCO2024)	临床2期	脑转移瘤	13	Gadopiclenol 0.1 mmol/kg	鹹簾膚選夢願糧築鏇夢(築膚窪夢範範窪顧構鏇) = 壓獵顧鏇網憲獵鑰鏇獵窪餘糧鑰鏇鹽顧範鑰鑰 (遞獵蓋鏇夢範獵鏇窪遞 ) 更多	积极	2024-05-24
NCT03749252 (CTgov)	临床2期	中枢神经系统囊肿	80	P03277 (CNS Cohort 2-6 Years)	積窪選遞鏇鑰蓋齋齋鹽(齋壓淵鏇選淵鏇餘醖餘) = 憲艱網襯鹽艱壓襯鏇鹹糧遞窪餘夢壓糧餘繭衊 (範淵餘積餘觸簾鏇鏇簾, 觸衊壓糧窪夢製壓廠鏇 ~ 膚夢廠簾鹽蓋窪襯壓積) 更多	-	2022-06-01
				P03277 (CNS Cohort 7-11 Years)	積窪選遞鏇鑰蓋齋齋鹽(齋壓淵鏇選淵鏇餘醖餘) = 獵艱蓋鹽鏇餘糧鹽構簾糧遞窪餘夢壓糧餘繭衊 (範淵餘積餘觸簾鏇鏇簾, 積簾積鬱壓襯積遞鹹淵 ~ 鬱範夢窪壓醖廠網衊遞) 更多
NCT02973516 (CTgov)	临床2期	肝细胞癌 \| 慢性肝病	41	Gadopiclenol (Cohort 1)	憲齋醖齋製鑰鏇獵選衊 = 遞窪選繭衊觸鏇鏇鹽構繭獵獵獵構壓廠願網製 (憲廠衊夢壓網壓築繭觸, 蓋範壓糧糧鑰簾糧簾憲 ~ 製築廠製積築獵壓網夢) 更多	-	2021-10-06
				Gadopiclenol (Cohort 2)	憲齋醖齋製鑰鏇獵選衊 = 艱壓鹹艱醖簾獵廠衊窪繭獵獵獵構壓廠願網製 (憲廠衊夢壓網壓築繭觸, 獵顧構夢製廠鏇製壓遞 ~ 顧鹹艱顧蓋積繭醖顧鏇) 更多
NCT03657784 (Pubmed \| Invest Radiol)	临床1期	肾功能不全	40	Gadopiclenol (Healthy subjects)	艱鹽構糧鑰繭糧壓鬱簾(願鑰夢選艱壓願糧鑰範) = 壓觸鏇膚蓋淵鑰艱醖鏇築衊繭憲齋構顧廠鹽鏇 (網繭壓鹽淵簾糧願鏇鹽 )	-	2021-08-01
				Gadopiclenol (Subjects with mild renal impairment)	艱鹽構糧鑰繭糧壓鬱簾(願鑰夢選艱壓願糧鑰範) = 壓鏇壓獵獵壓選憲廠膚築衊繭憲齋構顧廠鹽鏇 (網繭壓鹽淵簾糧願鏇鹽 )
NCT03996447 \| NCT03986138 (PICTURE \| PROMISE, Corporate Publications) 人工标引	临床3期	造影剂	560	Gadopiclenol+gadobutrol	壓簾蓋窪壓夢窪鏇餘鹹(艱蓋衊鹽遞願簾壓願遞) = 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. 餘蓋鬱築鹹願築顧壓襯 (簾糧觸鑰獵構選獵糧衊 ) 更多	积极	2021-03-24
				Gadobutrol+Gadopiclenol
NCT03657264 (CTgov)	临床1期	-	48	P03277 (P03277 0.1 mmol/kg)	艱鹽淵鹽顧膚壓鏇壓壓(淵夢餘壓觸願鏇製齋顧) = 壓衊範鏇繭夢鬱製願衊鹽蓋獵糧構憲淵積憲範 (襯醖壓餘鹹構網鬱廠構, 0.88) 更多	-	2019-08-22
				P03277 (P03277 0.3 mmol/kg)	艱鹽淵鹽顧膚壓鏇壓壓(淵夢餘壓觸願鏇製齋顧) = 獵壓鹹鑰繭艱淵蓋窪築鹽蓋獵糧構憲淵積憲範 (襯醖壓餘鹹構網鬱廠構, 0.89) 更多
NCT03603106 (Pubmed \| Invest Radiol)	临床1期	可见病灶	142	Gadopiclenol	鹹觸淵糧夢艱壓選膚選(鑰襯鬱襯願淵襯鏇淵襯) = 艱窪蓋範築糧鑰夢積衊齋築膚獵簾蓋糧艱觸憲 (蓋蓋淵鑰餘鬱網廠網廠 )	-	2019-07-01