– Bayer today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates.

– 拜耳今天宣布已向美国食品药品监督管理局（FDA）提交其在研造影剂钆喹酸盐（gadoquatrane）的新药申请（NDA），用于成人及包括足月新生儿在内的儿科患者的中枢神经系统及其他身体部位的增强磁共振成像。

The submitted dose is 0.04 mmol gadolinium per kilogram body weight. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S., corresponding to a 60 percent reduction compared to standard of care macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight..

提交的剂量为每公斤体重0.04毫摩尔钆。如果获得批准，钆喹特兰将成为美国可用的最低剂量的环状GBCA，相比目前标准治疗中环状GBCA的每公斤体重0.1毫摩尔钆的剂量减少了60%。

The submission of gadoquatrane to the U.S. FDA is based on positive data from the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane in adult and pediatric patients globally. The first results from the Phase III QUANTI CNS study were presented at the European Congress of Radiology (ECR) in February of this year and further results are planned to be presented at upcoming scientific meetings..

加多曲酸钆提交美国FDA的申请基于关键的III期QUANTI研究的积极数据，这些研究评估了加多曲酸钆在成年和儿童患者中的有效性和安全性。III期QUANTI CNS研究的首批结果在今年二月的欧洲放射学大会（ECR）上公布，更多结果计划在即将举行的科学会议上展示。

Nearly 40 million MRI scans are performed each year in the United States. “There is a rising need for medical imaging, among others driven by the increasing incidence of chronic diseases such as cancer and cardiovascular diseases,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development, Bayer.

每年在美国进行的核磁共振扫描接近 4000 万次。“医疗成像的需求在不断增长，部分原因是由癌症和心血管疾病等慢性病发病率的增加所推动的，”拜耳公司放射学研发主管康斯坦策·迪芬巴赫博士说道。

“As a leader in radiology, we are committed to advancing innovation in this field, including options to reduce the gadolinium dose. Patients can benefit from a dose reduction, especially patients with chronic conditions who require multiple contrast-enhanced MRI examinations during their lifetime. This is in line with guidance from health authorities and guidelines from scientific bodies which recommend using the lowest dose required to obtain the needed clinical information.”.

“作为放射学领域的领导者，我们致力于推进该领域的创新，包括减少钆剂量的选择。患者可以从减少剂量中受益，特别是那些患有慢性疾病、在其一生中需要多次进行增强核磁共振检查的患者。这与卫生当局的指导和科学机构的指南相一致，它们建议使用获取所需临床信息所需的最低剂量。”

Bayer recently announced the submission of gadoquatrane to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, marking the first application for marketing authorization for the investigational contrast agent. Further regulatory applications to health authorities worldwide are planned for the coming months..

拜耳近日宣布已向日本厚生劳动省 (MHLW) 提交了钆喹酸的上市许可申请，这是该研究性造影剂的首次申请。未来几个月内计划向全球其他健康机构提交更多的监管申请。

About the Phase III development program QUANTI

关于III期开发计划QUANTI

The pivotal QUANTI clinical development program investigated gadoquatrane at a dose of 0.04 mmol Gd/kg body weight, which represents a 60 percent lower gadolinium dose compared to macrocyclic contrast agents dosed at 0.1 mmol Gd/kg body weight. QUANTI 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.

关键的QUANTI临床开发项目研究了以0.04毫摩尔钆/公斤体重剂量使用的加多喹特，这一剂量比以0.1毫摩尔钆/公斤体重给药的环型造影剂的钆剂量低60%。QUANTI包括两项大型多国、随机、前瞻性双盲、交叉的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。

In total, 808 patients in 15 countries participated in the program. The QUANTI study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection..

共有 15 个国家的 808 名患者参与了该计划。QUANTI 研究结果表明，钆喹酸在评估可视化参数和病灶检测的研究中达到了主要和次要疗效终点。

Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that in adults. The observed safety profile in adults as well as pediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs.

QUANTI儿科研究的结果表明，钆喹酸在儿童中的药代动力学行为与成人相似。在QUANTI研究中，从出生到未满18岁的成人及儿科患者中观察到的安全性特征与以往关于钆喹酸和其他大环状GBCAs的数据基本一致。

No new safety signals were observed..

未观察到新的安全信号。

About gadoquatrane

关于加多喹烷

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

Gadoquatrane 是拜耳公司正在临床开发中的新型细胞外大环状对比剂，用于增强MRI的对比度。这种低剂量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

With an estimated 65 million procedures performed annually worldwide, contrast-enhanced MRI plays a key role in the healthcare continuum. 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.

据估计，全球每年进行约6500万次增强核磁共振成像检查，核磁共振在医疗连续体中发挥着关键作用。核磁共振是一种无创、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。

This supports physicians in answering critical medical questions related to the detection and monitoring of diseases..

这有助于医生回答与疾病检测和监测相关的关键医学问题。

About Radiology at Bayer

关于拜耳的放射学

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，拜耳致力于提供创新产品和高品质的诊断成像服务，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（如计算机断层扫描（CT）、X射线、磁共振成像（MRI）以及正电子发射断层扫描（PET））的对比剂和精确施药装置。

Bayer’s comprehensive offerings also include informatics solutions and a medical imaging platform with digital and artificial intelligence (AI) powered applications. 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和一个包含数字及人工智能（AI）驱动应用的医学影像平台。2024年，拜耳的放射学产品销售额达到21亿欧元。拜耳持续推进医学影像领域的研究与创新，其中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.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对全球人口增长和老龄化带来的重大挑战，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。2024财年，集团拥有约93,000名员工，销售额达466亿欧元。