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拜耳将通过收购Attralus的创新性泛淀粉样蛋白放射性示踪剂,进军分子影像领域

Bayer to expand into molecular imaging with acquisition of innovative pan-amyloid radiotracers from Attralus

拜耳 等信源发布 2026-01-12 21:05

可切换为仅中文


12

12

January

一月

2026

2026

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13:59 PM

13:59 PM

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer to expand into molecular imaging with acquisition of innovative pan-amyloid radiotracers from Attralus

拜耳将通过收购 Attralus 的创新型泛淀粉样蛋白放射性示踪剂,进军分子影像领域。

Not intended for UK Media

不适用于英国媒体

Summary

摘要

Bayer bolsters development portfolio by acquisition of two investigational imaging agents (AT-01 and AT-05) from Attralus, Inc. to advance diagnosis for cardiac amyloidosis / PET tracer AT-01 in Phase III and SPECT tracer AT-05 in Phase I of clinical development specifically designed for the diagnosis of cardiac as well as other types of systemic amyloidosis / Potential to address the growing need for earlier and accurate diagnosis of these often underdiagnosed conditions / AT-01 (124-Iodine-evuzamitide) is first pan-amyloid imaging agent with U.S.

拜耳通过收购Attralus公司的两种在研影像剂(AT-01和AT-05)来加强其开发组合,以推进心脏淀粉样变性的诊断。/ PET示踪剂AT-01处于III期临床开发阶段,SPECT示踪剂AT-05处于I期临床开发阶段,专门设计用于诊断心脏及其他类型的系统性淀粉样变性。/ 具有满足这些常被低估的疾病对更早期和更准确诊断需求的潜力。/ AT-01(124-碘-evuzamitide)是美国首个泛淀粉样蛋白成像剂。

FDA Breakthrough Therapy Designation for cardiac amyloidosis; AT-01 also holds Orphan Drug Designation in U.S. and EU / Building on its comprehensive radiology portfolio including advanced fluid delivery devices in molecular imaging, Bayer reinforces its ambition to expand in this rapidly growing field by entering the area of diagnostic tracers, while bolstering its position in cardiovascular precision medicine / Attralus will now focus on advancing its innovative pan-amyloid removal therapeutics, with AT-02 in Phase II and next generation candidates in preclinical development.

FDA授予治疗心脏淀粉样变性的突破性疗法认定;AT-01还获得了美国和欧盟的孤儿药认定 / 拜耳基于其包括分子影像学中先进的流体输送装置在内的综合放射学产品组合,通过进入诊断示踪剂领域,强化了其在这一快速增长领域的扩展雄心,同时巩固了其在心血管精准医疗中的地位 / Attralus将专注于推进其创新的泛淀粉样蛋白清除疗法,其中AT-02处于II期临床,下一代候选药物正在临床前开发中。

Berlin, Germany and Naples (FL), US, January 12, 2026

德国柏林,美国佛罗里达州那不勒斯,2026年1月12日

– Bayer, a leading company in key areas of radiology and cardiology, and Attralus, Inc. (Attralus), a clinical stage biopharmaceutical company focused on developing medicines and diagnostics for systemic amyloidosis, today announced that the companies have entered into definitive agreements for Bayer to acquire AT-01 (124-Iodine-evuzamitide) and AT-05 (PAR-Peptide + technetium-99m), two investigational molecular imaging agents for the diagnosis of cardiac amyloidosis, from Attralus.

– 拜耳,作为放射学和心脏病学关键领域的领先公司,与专注于开发治疗全身性淀粉样变性的药物和诊断工具的临床阶段生物制药公司Attralus, Inc.(Attralus)今天宣布,双方已达成最终协议,拜耳将从Attralus收购两种用于诊断心脏淀粉样变性的研究性分子影像剂AT-01(124-碘-evuzamitide)和AT-05(PAR-肽+锝-99m)。

This strategic acquisition reinforces Bayer’s ambition to expand in the rapidly growing field of molecular imaging and supports the company’s broader precision cardiology strategy..

这一战略性收购加强了拜耳在快速增长的分子影像领域扩张的雄心,并支持了公司更广泛的精准心脏病学战略。

“With this strategic acquisition and the integration of novel molecular tracers into our development portfolio, we are advancing Bayer’s innovation strategy,” said Stefan Oelrich, Member of the Board of Management of Bayer AG and President of Bayer’s Pharmaceuticals Division. “AT-01 and AT-05 are precisely engineered to detect cardiac amyloidosis with high accuracy, enabling timely intervention and improved patient outcomes – a clear extension of our commitment to tackling cardiovascular disease and addressing significant unmet needs.”.

“通过这一战略性收购并将新型分子示踪剂整合到我们的开发组合中,我们正在推进拜耳的创新战略,”拜耳股份公司管理委员会成员兼拜耳制药部门总裁斯特凡·奥尔里希表示。“AT-01 和 AT-05 精准设计用于高精度检测心脏淀粉样变性,从而实现及时干预并改善患者预后——这是我们致力于解决心血管疾病和满足重大未满足需求的明确延伸。”

The acquired molecular imaging portfolio consists of AT-01 (124-Iodine-evuzamitide, a tracer for Positron Emission Tomography; PET) in Phase III of clinical development and AT-05 (PAR-Peptide + technetium-99m, a tracer for Single Photon Emission Computed Tomography; SPECT) in Phase I of clinical development, focused on the diagnosis of cardiac amyloidosis.

收购的分子影像产品组合包括处于临床开发第三阶段的AT-01(124碘-evuzamitide,用于正电子发射断层扫描;PET示踪剂)和处于临床开发第一阶段的AT-05(PAR肽+锝-99m,用于单光子发射计算机断层扫描;SPECT示踪剂),专注于心肌淀粉样变性的诊断。

The development of these tracers has the potential to address the urgent need for earlier and accurate diagnosis of systemic and specifically cardiac amyloidosis, a rarely diagnosed and often fatal heart disease that affects an estimated 400,000 people globally. With current methods, these conditions are often underdiagnosed and difficult to detect..

这些示踪剂的发展有可能满足对系统性淀粉样变性和特别是心脏淀粉样变性早期和准确诊断的迫切需求,这是一种很少被诊断但常常致命的心脏病,全球约有40万人受到影响。使用当前的方法,这些病症往往被漏诊且难以检测。

“With new therapies emerging for often insufficiently treated conditions such as cardiac amyloidosis, it becomes increasingly relevant to precisely detect and monitor diseases on the molecular level,” said Nelson Ambrogio, President Radiology at Bayer. “This acquisition marks our entry into diagnostic tracers.

“随着针对常常治疗不足的疾病(如心脏淀粉样变性)的新疗法不断涌现,在分子层面上精准检测和监测疾病变得越来越重要,”拜耳公司放射学总裁纳尔逊·安布罗吉奥表示。“此次收购标志着我们进入诊断示踪剂领域。”

Leveraging our expertise in medical imaging – including our pipeline and portfolio in advanced fluid delivery devices for nuclear medicine – it supports our ambition to expand in the growing field of molecular imaging. Building on Attralus’ research and development expertise, we will further advance scientific progress with the aim to broaden diagnostic options and make a meaningful difference for people living with cardiac amyloidosis.”.

利用我们在医学影像方面的专业知识——包括我们在核医学先进流体输送装置的管线和产品组合——这将支持我们扩大在不断增长的分子影像领域的雄心。基于Attralus的研发专长,我们将进一步推动科学进步,旨在拓宽诊断选择,为患有心脏淀粉样变性的人们带来有意义的改变。

The global market for radio-diagnostic tracers was valued at approximately 3 billion USD in 2024 and is projected to grow significantly in the coming years. With its comprehensive portfolio in Radiology, its expertise in medical imaging and clinical development and global commercial infrastructure, Bayer is uniquely positioned to accelerate innovation and deliver integrated offerings that address evolving clinical needs and have the potential to improve patient outcomes worldwide..

2024年,放射诊断示踪剂的全球市场价值约为30亿美元,并预计在未来几年将显著增长。拜耳凭借其在放射学领域的全面产品组合、医学影像和临床开发的专业知识,以及全球商业基础设施,占据了独特地位,能够加速创新并提供满足不断变化的临床需求的综合解决方案,有望改善全球患者的治疗效果。

“We are excited to finalize this agreement with Bayer, whose expertise and global footprint in radiology will help to accelerate the development and launch of AT-01 and AT-05, our two novel diagnostic imaging agents for systemic amyloidosis,” said Glen Firestone, President of Attralus. “Despite recent progress in systemic amyloidosis, most patients continue to remain undiagnosed or are diagnosed too late in their disease progression.

“我们很高兴与拜耳达成这项最终协议,拜耳在放射学领域的专业能力和全球影响力将有助于加速我们两款新型全身性淀粉样变诊断成像剂AT-01和AT-05的开发和上市,”Attralus公司总裁格伦·费尔斯通表示。“尽管全身性淀粉样变领域最近取得了一些进展,但大多数患者仍然未能得到诊断,或是在疾病进展过晚时才被确诊。”

Consistent with Attralus’ mission, we believe that these pan-amyloid imaging agents will enable earlier diagnosis and treatment, leading to improved patient outcomes. Bayer’s commitment to scientific rigor and patient impact makes them well-suited to bring these agents to clinicians and patients worldwide.

与Attralus的使命一致,我们相信这些泛淀粉样蛋白成像剂将能够实现更早的诊断和治疗,从而改善患者的预后。拜耳对科学严谨性和患者影响的承诺使他们非常适合将这些药物带给全球的临床医生和患者。

Attralus will now focus on advancing its innovative pan-amyloid removal therapeutics, with AT-02 in Phase II and next generation candidates in preclinical development.”.

Attralus现在将专注于推进其创新的泛淀粉样蛋白清除疗法,其中AT-02处于二期临床阶段,下一代候选药物正在临床前开发中。

The financial details of the acquisition were not disclosed.

收购的财务细节未被披露。

About AT-01 and AT-05

关于AT-01和AT-05

AT-01 (124-Iodine-evuzamitide) is a non-invasive pan-amyloid PET (Positron Emission Tomography) imaging agent specifically designed for accurate diagnosis of amyloid disease, including in the heart. AT-01 utilizes a proprietary pan-amyloid binding peptide labeled with iodine-124 as an amyloid-specific radiotracer to detect all types of systemic amyloidosis using PET imaging.

AT-01(124碘标记的evuzamitide)是一种非侵入性的泛淀粉样蛋白PET(正电子发射断层扫描)显像剂,专门设计用于准确诊断包括心脏在内的淀粉样蛋白疾病。AT-01利用一种专有的泛淀粉样蛋白结合肽,并用碘-124标记作为淀粉样蛋白特异性放射性示踪剂,通过PET成像检测所有类型的系统性淀粉样变病。

In clinical trials, AT-01 has been observed to detect multiple types of amyloid deposits with high sensitivity and specificity, including ATTR (transthyretin amyloid cardiomyopathy) and AL (light chain amyloidosis), in major organs such as the heart, kidney, liver, and spleen. AT-01 is one of the first investigational diagnostic imaging agents to receive Breakthrough Therapy Designation (BTD) from the U.S.

在临床试验中,AT-01 被观察到能够以高灵敏度和高特异性检测多种类型的淀粉样蛋白沉积,包括心脏、肾脏、肝脏和脾脏等主要器官中的 ATTR(转甲状腺素蛋白淀粉样变心肌病)和 AL(轻链淀粉样变性)。AT-01 是首批获得美国突破性疗法认定(BTD)的在研诊断成像剂之一。

Food and Drug Administration, and the only diagnostic imaging agent that has received BTD for cardiac amyloidosis. The compound has received orphan drug designation as a diagnostic for the management of ATTR and AL amyloidosis in the U.S. and the EU. The Phase III study REVEAL with AT-01 in patients with suspected cardiac amyloidosis is ongoing and has completed dosing as of the time of this release..

食品和药物管理局,也是唯一获得BTD认证的心脏淀粉样变诊断成像剂。该化合物在美国和欧盟已被授予孤儿药资格,用于ATTR和AL淀粉样变的诊断管理。正在进行的使用AT-01针对疑似心脏淀粉样变患者的III期研究REVEAL在本发布时已完成给药。

AT-05 (PAR-Peptide + technetium-99m) is a Single Photon Emission Computed Tomography (SPECT) tracer currently in Phase I development. It represents an additional diagnostic option using SPECT technology, which could broaden patient access.

AT-05(PAR-肽 + 锝-99m)是一种目前处于一期开发阶段的单光子发射计算机断层扫描(SPECT)示踪剂。它代表了使用SPECT技术的另一种诊断选择,可能会扩大患者的应用范围。

About Cardiac Amyloidosis

关于心脏淀粉样变性

Cardiac amyloidosis is a spectrum of diseases caused by the abnormal build-up of a protein, called amyloid, in the heart tissue. These deposits accumulate between the heart cells, making the heart muscle thick and stiff, preventing it from pumping blood effectively and leading to heart failure and heart rhythm problems.

心肌淀粉样变性是一组由心脏组织中一种叫做淀粉样蛋白的异常堆积引起的疾病。这些沉积物在心肌细胞之间积累,使心肌变得厚实和僵硬,导致心脏无法有效泵血,进而引发心力衰竭和心律问题。

Advanced stages of cardiac amyloidosis can result in cardiomyopathy. Cardiac amyloidosis may be an underlying condition in a relevant portion of patients with heart failure..

心脏淀粉样变性的晚期可能导致心肌病。心脏淀粉样变性可能是相当一部分心力衰竭患者的基础疾病。

Clinical recognition of cardiac amyloidosis at an early stage of the disease is important for adequate and effective patient management with existing therapeutic options. The disease is often diagnosed late, when the accumulation of amyloid has already occurred, and patients have irreversible loss of heart function and diminished quality of life..

早期临床识别心脏淀粉样变性对于利用现有治疗方案进行充分有效的患者管理非常重要。该病常在淀粉样蛋白已经积累、患者心脏功能出现不可逆丧失以及生活质量下降时才被诊断出来。

As a leader in cardiology, Bayer is advancing a portfolio of innovative treatments in cardiovascular diseases of high unmet medical need. The company is accelerating its shift towards precision cardiology to advance patient outcomes. Bayer’s portfolio already includes several innovative products – from diagnosis to care – including Beyonttra™ (acoramidis) for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), and compounds in various stages of preclinical and clinical development..

作为心脏病学领域的领导者,拜耳正在推进一系列针对高未满足医疗需求的心血管疾病创新治疗方案。公司正在加速向精准心脏病学的转变,以改善患者的治疗效果。拜耳的产品组合已经包括多种创新产品——从诊断到治疗——其中包括用于治疗成年心肌病患者的野生型或变异型转甲状腺素蛋白淀粉样变性(ATTR-CM)的Beyonttra™(acoramidis),以及处于不同临床前和临床开发阶段的化合物。

About Molecular Imaging

关于分子影像学

Molecular imaging allows clinicians to visualize and quantify biological processes at the molecular and cellular level in real time, enabling earlier disease detection and personalized treatment planning. Bayer is committed to advancing this field through innovative technologies and strategic collaborations..

分子影像技术使临床医生能够实时可视化并量化分子和细胞层面的生物过程,从而实现更早的疾病检测和个性化的治疗规划。拜耳致力于通过创新技术和战略合作伙伴关系推动这一领域的发展。

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. As a leader in key areas of radiology, the company’s 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。作为放射学关键领域的领导者,该公司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 in molecular imaging..

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,包括分子影像领域。

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具有核心竞争力的生命科学领域企业,专注于医疗保健和营养。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,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 。

www.bayer.com

www.bayer.com

.

About Attralus

关于Attralus

Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines and diagnostics to improve the lives of patients with systemic amyloidosis. The company’s proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues.

Attralus是一家处于临床阶段的生物制药公司,专注于开发变革性药物和诊断工具,以改善全身性淀粉样变性患者的生活。该公司专有的泛淀粉样蛋白清除(PAR)疗法旨在直接结合并去除器官和组织中的毒性淀粉样蛋白。

By targeting the disease-causing pathology in systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and the company is headquartered in Naples, FL..

通过针对系统性淀粉样变性疾病中的致病病理,PAR 治疗药物有潜力治疗和逆转所有类型和阶段的系统性淀粉样变性患者的疾病。Attralus 由淀粉样变性领域的科学专家创立,公司总部位于佛罗里达州那不勒斯。

Find more information at

更多信息请访问

https://pharma.bayer.com

https://pharma.bayer.com

Follow us on Facebook:

在Facebook上关注我们:

http://www.facebook.com/bayer

http://www.facebook.com/bayer

Follow us on Twitter:

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实际的未来结果、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

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:

Anna Koch, phone +49 1605873010

安娜·科赫,电话 +49 1605873010

Email:

电子邮件:

anna.koch@bayer.com

安娜.科赫@拜耳.com

US contact for media inquiries:

媒体查询的美国联系人:

Elaine Colon, phone +1 732 236 1587

伊莱恩·科隆,电话 +1 732 236 1587

Email:

电子邮件:

elaine.colon@bayer.com

elaine.colon@bayer.com

Attralus contact for media inquiries:

Attralus 媒体咨询联系方式:

Krishna Gorti, M.D. FRCS, phone +1 415 231 7338

克里希纳·戈尔蒂,医学博士,FRCS,电话 +1 415 231 7338

Corporate Development

企业发展

Email:

电子邮件:

kgorti@attralus.com

kgorti@attralus.com

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2026-0015e.pdf

2026-0015e.rtf

2026-0015e.rtf

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