2025年RSNA会议上展示了拜耳公司用于儿科研究的实验性MRI造影剂的数据-动脉网

Data from Pediatric Study for Bayer's Investigational MRI Contrast Agent presented at RSNA 2025

拜耳等信源发布 2025-12-03 23:01

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December

十二月

2025

16:00 PM

Europe/Amsterdam

欧洲/阿姆斯特丹

Data from Pediatric Study for Bayer's Investigational MRI Contrast Agent presented at RSNA 2025

拜耳实验性MRI造影剂的儿科研究数据在RSNA 2025上公布

Not intended for U.S. and UK Media – Late-breaking data from QUANTI Pediatric presented at RSNA 2025:

不适用于美国和英国媒体——QUANTI儿科在RSNA 2025上展示的最新数据：

Summary

摘要

Bayer revealed first results of the pediatric study from the pivotal clinical development program QUANTI for its low-dose MRI contrast agent / QUANTI Pediatric evaluated the pharmacokinetics and safety of gadoquatrane in children (birth to <18) at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight / Data are part of submissions to health authorities worldwide to secure marketing authorization for gadoquatrane.

拜耳公布了其低剂量MRI对比剂的关键临床开发项目QUANTI的儿科研究的初步结果 / QUANTI Pediatric评估了钆喹曲兰在儿童（出生至<18岁）中的药代动力学和安全性，钆剂量为0.04 mmol Gd/kg体重，相较于以0.1 mmol Gd/kg体重给药的环状GBCAs减少了60%的剂量 / 数据已提交给全球卫生监管机构，以确保钆喹曲兰的上市许可。

Berlin, December 3, 2025

柏林，2025年12月3日

– Bayer, a global leader in radiology, today revealed results from the QUANTI Pediatric study, adding to the safety and efficacy data of the investigational low-dose MRI gadolinium-based contrast agent (GBCA) gadoquatrane. QUANTI Pediatric evaluated gadoquatrane in children with known or suspected disease undergoing contrast-enhanced magnetic resonance imaging (MRI) at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.

– 拜耳，作为全球放射学领域的领导者，今天公布了QUANTI儿科研究的结果，为研究中的低剂量MRI钆基对比剂（GBCA）加多夸特兰增添了安全性和有效性数据。QUANTI儿科研究在已知或疑似疾病并接受增强磁共振成像（MRI）的儿童中评估了加多夸特兰，钆剂量为0.04 mmol Gd/kg体重，相较于以0.1 mmol Gd/kg体重给药的环状GBCA，剂量减少了60%。

The study met the primary and secondary endpoints, assessing the pharmacokinetic and safety profile of gadoquatrane. Similar pharmacokinetic behavior was observed in the pediatric population, indicating that diagnostic performance of gadoquatrane in adults can also be applied to children. Details of QUANTI Pediatric were presented as late-breaking clinical trial data at this year’s annual congress of the Radiological Society of North America (RSNA) taking place in Chicago, USA, from November 30 to December 4, 2025..

该研究达到了主要和次要终点，评估了钆喹酸的药代动力学和安全性。在儿科人群中观察到相似的药代动力学行为，表明钆喹酸在成人中的诊断性能也可应用于儿童。QUANTI Pediatric 的详细信息作为最新突破性临床试验数据在今年的北美放射学会 (RSNA) 年会上发布，会议于 2025 年 11 月 30 日至 12 月 4 日在美国芝加哥举行。

QUANTI Pediatric is part of Bayer’s pivotal QUANTI clinical development program, which also encompassed two multinational Phase III studies in adults. Based on positive QUANTI data, including the pediatric study, Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, such as Japan, the U.S., the EU, and China, with further markets to follow in the next months.

QUANTI儿科研究是拜耳关键的QUANTI临床开发项目的一部分，该项目还包括两项针对成人的多国III期研究。基于包括儿科研究在内的积极的QUANTI数据，拜耳已向日本、美国、欧盟和中国等全球市场提交了gadoquatrane的上市许可申请，并计划在未来几个月内覆盖更多市场。

If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent available in the respective markets..

如果获得批准，钆喹特酸将成为各自市场上可用的最低剂量的环状钆基对比剂。

“Contrast-enhanced MRI is increasingly used to assist in diagnosis and monitoring of certain conditions, from newborns to adulthood,” said Talissa Altes, MD, Professor and Chair of Radiology at the University of Missouri, USA. “MRI is particularly valuable in pediatric care due to its non-invasive nature: it supports for example the diagnosis and follow-up of potential tumors as well as various neurological diseases such as multiple sclerosis in children.

“增强对比度的核磁共振成像在从新生儿到成人的某些疾病的诊断和监测中使用越来越广泛，”美国密苏里大学放射学教授兼主任塔丽莎·阿尔特博士说道。“核磁共振在儿科护理中特别有价值，因为它具有非侵入性：它支持例如潜在肿瘤的诊断和随访，以及儿童多发性硬化症等各种神经系统疾病的监测。”

As MRI contrast agents commonly contain gadolinium, it can be especially relevant for patient groups that require multiple MRI exams over their lifetime, like pediatric patients, to have a low-dose contrast agent option to reduce lifetime exposure.”.

由于核磁共振成像（MRI）造影剂通常含有钆，对于那些一生中需要多次进行核磁共振检查的患者群体（如儿科患者）来说，拥有一个低剂量造影剂的选择以减少终生暴露量尤其重要。

An estimated 1.5 million contrast-enhanced MRIs are performed in children annually around the world – and this number is rising by 5% per year.

据估计，全世界每年进行约150万次儿童增强对比磁共振成像 (MRI) 检查——而且这个数字正以每年5%的速度增长。

“Contrast-enhanced MRI serves as a crucial tool for disease detection and the ongoing condition management, including in children, and Bayer is committed to driving innovation in this important area,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division.

“增强对比的核磁共振成像在疾病检测和持续病情管理中起着至关重要的作用，包括在儿童中的应用，拜耳致力于推动这一重要领域的创新，” 拜耳制药部门放射学研发主管康斯坦策·迪芬巴赫博士表示。

“The QUANTI Pediatric results highlight gadoquatrane's potential as a low-dose MRI contrast agent for children. A low dose is also in line with health authorities and scientific bodies which advise using the lowest dose required to obtain the needed clinical information. We look forward to ongoing collaborations with regulatory authorities around the world to make gadoquatrane accessible to patients and their healthcare providers as swiftly as possible.”.

“QUANTI儿科研究结果突显了钆喹特兰作为低剂量MRI对比剂在儿童中的潜力。低剂量也符合卫生当局和科学机构的建议，即使用获得所需临床信息的最低剂量。我们期待与全球监管机构持续合作，尽快使钆喹特兰惠及患者及其医疗服务提供者。”

About QUANTI Pediatric and the Phase III development program QUANTI

关于QUANTI儿科和III期开发计划QUANTI

QUANTI Pediatric was a multicenter, prospective, open-label study to evaluate the pharmacokinetics, safety and tolerability of gadoquatrane in children from birth to under 18 years old. The observed pharmacokinetic behaviour of gadoquatrane in children was similar to that in adults. The safety profile was in line with previous findings on gadoquatrane and other macrocyclic GBCAs.

QUANTI儿科研究是一项多中心、前瞻性、开放标签的研究，旨在评估钆喹酸盐在出生至18岁以下儿童中的药代动力学、安全性和耐受性。观察到的钆喹酸盐在儿童中的药代动力学行为与成人相似。其安全性特征与之前关于钆喹酸盐和其他大环状GBCAs的研究结果一致。

Additionally, the study assessed diagnostic performance in the pediatric population. Results show that gadoquatrane improved visualization and other key parameters when compared to pre-contrast MRI scans..

此外，该研究还评估了在儿科人群中的诊断性能。结果显示，与增强前的磁共振成像扫描相比，钆喹特林提高了可视化效果及其他关键参数。

The pivotal QUANTI clinical development program for gadoquatrane consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies – QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) – as well as the QUANTI Pediatric study. In total, 808 patients – including 93 children – in 15 countries participated in the program.

加多夸特兰的关键QUANTI临床开发项目包括两项大型多国、随机、前瞻性双盲、交叉III期研究——QUANTI CNS（中枢神经系统）和QUANTI OBR（其他身体区域）——以及QUANTI儿科研究。总计有来自15个国家的808名患者参与了该项目，其中包括93名儿童。

The results of the QUANTI studies show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection, while reducing the gadolinium dose by 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. In all studies, the observed safety profile was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs.

QUANTI 研究的结果表明，钆喹曲兰达到了评估可视化参数和病灶检测的研究的主要和次要疗效终点，同时与以 0.1 mmol Gd/kg 体重给药的环状 GBCA 相比，钆剂量减少了 60%。在所有研究中，观察到的安全性特征通常与之前关于钆喹曲兰和其他大环 GBCA 的数据一致。

No new safety signals were observed..

未观察到新的安全信号。

Further study data are planned to be presented at upcoming scientific meetings.

计划在即将召开的科学会议上展示进一步的研究数据。

About gadoquatrane

关于加多夸特兰

Gadoquatrane is Bayer’s investigational extracellular macrocyclic contrast agent for contrast enhancement in MRI. This low-dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity.

Gadoquatrane 是拜耳公司研发的用于磁共振成像（MRI）增强的细胞外大环状对比剂。这种低剂量的钆基对比剂具有独特的四聚体结构，具备高稳定性和高弛豫率。

About MRI

关于MRI

MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. Approximately 12-18 million contrast-enhanced MRI scans are performed annually in the United States.

MRI是一种无创、无辐射的成像方法，能够提供身体的详细图像，有助于识别和区分器官和组织中的潜在异常。这帮助医生回答与疾病检测和监测相关的关键医学问题。在美国，每年大约进行1200万到1800万次增强对比的MRI扫描。

Since their introduction in 1988, more than 800 million GBCA doses have been administered worldwide, with an estimated 63 million doses in 2023..

自1988年推出以来，全球已施用超过8亿剂GBCA，估计2023年达到6300万剂。

About Radiology at Bayer

拜耳放射学相关

Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET).

基于一个世纪的专业知识，拜耳致力于在诊断成像领域提供创新产品和高质量服务，以提升患者护理水平。其领先的放射学产品组合包括用于各种成像模式的对比剂和精密给药装置，涵盖计算机断层扫描（CT）、X射线、磁共振成像（MRI）以及正电子发射断层扫描（PET）。

Bayer’s comprehensive offerings also include informatics solutions. In 2024, Bayer’s radiology products generated €2.1 billion in sales. Bayer continues to advance research and innovation in medical imaging, including the integration of AI..

拜耳的综合产品还包括信息学解决方案。2024年，拜耳的放射学产品销售额达到21亿欧元。拜耳继续推进医学影像领域的研究与创新，包括人工智能的整合。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在全球范围内拥有医疗保健和营养等生命科学领域核心竞争力的企业。秉承“人人健康，无人饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，该集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用达62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

在Facebook上关注我们：

http://www.facebook.com/bayer

在 Twitter 上关注我们：

@BayerPharma

@拜耳制药

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司的实际未来结果、财务状况、发展或业绩与这里提供的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，该报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担更新这些前瞻性声明或使其符合的任何责任 whatsoever

them to future events or developments.

将它们应用于未来的事件或发展。

Global contacts for media inquiries:

全球媒体咨询联系方式：

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