– Bayer today announced that the Center of Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application for gadoquatrane. The investigational contrast agent is intended for contrast enhancement in MRI to detect and visualize known or suspected pathologies in all body regions and the central nervous system in adults and pediatric patients including neonates.

– 拜耳今天宣布，中国国家药品监督管理局药品审评中心已受理钆喹酸的新型药物申请。这种研究中的对比剂旨在用于磁共振成像（MRI）的对比增强，以检测和可视化成人及包括新生儿在内的儿童患者全身各区域及中枢神经系统的已知或疑似病变。

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

如果获得批准，钆喹酸将成为中国市场上可用的最低剂量的环型GBCA。提交的剂量为每公斤体重0.04毫摩尔钆，与目前标准治疗中环型对比剂每公斤体重0.1毫摩尔钆的剂量相比，钆剂量减少了60%。

“Magnetic resonance imaging is essential for informing and guiding treatment decisions, as evidenced by the increasing number of MRI procedures globally, including China,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. “With this submission, we seek to advance gadoquatrane as a potential low dose contrast agent option for MRI.

“磁共振成像是指导和告知治疗决策的重要手段，这一点从全球范围内越来越多的核磁共振成像检查程序中可以看出，其中也包括中国，” 拜耳制药部门放射学研发负责人康斯坦泽·迪芬巴赫博士说道。“通过此次申报，我们希望推动钆喹酸作为磁共振成像潜在的低剂量造影剂的选择。

This commitment aligns with recommendations from radiological societies in addition to European health authority guidance to use the minimum dose necessary to acquire the needed clinical information.”.

这项承诺符合放射学会的建议，同时也符合欧洲卫生当局关于使用获取所需临床信息的最低剂量的指导。

Patients, particularly those with chronic conditions who need multiple contrast-enhanced MRI scans over their lifetime, can benefit from a reduction in dosage. In China, approximately 16 million contrast-enhanced MRI scans are performed annually, with a growth rate of 15% in recent years.

患者，尤其是那些终生需要多次进行增强核磁共振扫描的慢性病患者，能够从减少钆造影剂的用量中受益。在中国，每年大约要进行1600万次增强核磁共振扫描，并且近年来以15%的速度增长。

The submission of gadoquatrane in China is based on positive data from the global pivotal Phase III QUANTI studies, which also included Chinese patients, evaluating the efficacy and safety across a broad range of indications in adult and pediatric patients. Additionally, the healthcare authorities in Japan, the U.S., the European Union and other countries are currently reviewing applications for marketing authorization for gadoquatrane.

加多曲酸在中国的提交基于全球关键的III期QUANTI研究的积极数据，该研究也包括了中国患者，评估了成人和儿童患者在广泛适应症中的疗效和安全性。此外，日本、美国、欧盟及其他国家的卫生监管机构目前正在审评加多曲酸的上市许可申请。

Further regulatory applications to health authorities worldwide are planned for the coming months..

未来几个月计划向全球各地的卫生当局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. 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钆喹酸盐在0.04 mmol Gd/kg体重剂量下的效果。QUANTI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（其他身体部位）——以及QUANTI儿科研究。

In total, 808 patients in 15 countries participated in the program. In China, 14 sites were included..

共有来自15个国家的808名患者参与了该项目，中国共纳入14个研究中心。

In QUANTI CNS and QUANTI OBR, researchers investigated the ability to visualize and detect known or suspected disease on MRI scans using gadoquatrane compared to scans without contrast injection and compared to scans using macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. The study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection.

在QUANTI CNS和QUANTI OBR研究中，研究人员评估了使用钆喹特兰（gadoquatrane）与未注射对比剂的扫描以及与使用剂量为0.1 mmol Gd/kg体重的环状GBCAs进行对比，在MRI扫描中可视化和检测已知或疑似病变的能力。研究结果显示，钆喹特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。

Results of QUANTI Pediatric demonstrated that the pharmacokinetic and safety profile of gadoquatrane in children is similar to that in adults. The safety events observed with gadoquatrane in the program were similar to those for the comparator macrocyclic gadolinium-based contrast agents with a low incidence of intervention related treatment emergent adverse events and generally consistent with previous data on gadoquatrane and other macrocyclic gadolinium-based contrast agents.

QUANTI儿科研究结果表明，钆喹酸在儿童中的药代动力学和安全性特征与成人相似。在该计划中观察到的钆喹酸安全事件与其他大环状钆基对比剂的安全事件相似，干预相关治疗出现的不良事件发生率较低，且总体上与之前关于钆喹酸和其他大环状钆基对比剂的数据一致。

No new safety signals were observed..

未观察到新的安全信号。

With first results from the Phase III QUANTI CNS study revealed at the European Congress of Radiology (ECR) in February of this year, further results are planned to be presented at upcoming scientific meetings.

今年2月在欧洲放射学大会（ECR）上公布了QUANTI CNS三期研究的初步结果，更多结果计划在接下来的科学会议上展示。

About gadoquatrane

关于加多曲坦

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研究性细胞外大环状对比剂，用于MRI的对比增强。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.

据统计，全球每年约进行6500万次增强核磁共振成像检查，核磁共振在医疗体系中发挥着关键作用。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, characterization, and monitoring of diseases..

这有助于医生回答与疾病检测、特征描述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).

拜耳在一个世纪的专业知识基础上，致力于提供创新产品和高品质服务在诊断成像领域以提高患者护理水平。其领先的放射学产品组合包括用于各种成像模式的造影剂和精密给药装置，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 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具有数字及人工智能（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 .

研发费用共计62亿欧元。欲了解更多信息，请访问 。