生命分子影像公司宣布Neuraceq®在PharmaLogic盐湖城可用-动脉网

Life Molecular Imaging announces Neuraceq® availability at PharmaLogic Salt Lake City

CISION 等信源发布 2025-04-25 01:43

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Enhanced the supply capabilities of Neuraceq® to increase patient access to beta-amyloid PET imaging

增强了Neuraceq®的供应能力，以增加患者获得β-淀粉样蛋白PET成像的机会。

BOSTON

波士顿

，

April 24, 2025

2025年4月24日

/PRNewswire/ -- Life Molecular Imaging (LMI) and PharmaLogic Holdings Corp. (PharmaLogic), a world-class contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announce the expansion of their strategic partnership and licensing agreement to produce and distribute Neuraceq® from PharmaLogic's PET radiopharmaceutical manufacturing facility located near .

/PRNewswire/ -- Life Molecular Imaging（LMI）与世界一流的合同开发和制造组织（CDMO）及放射药房解决方案提供商PharmaLogic Holdings Corp.（PharmaLogic）宣布扩大其战略合作伙伴关系和许可协议，将在PharmaLogic位于附近的PET放射性药物生产设施生产和分销Neuraceq®。

Salt Lake City, Utah

犹他州盐湖城

. The first commercial doses were made available on

第一批商业剂量于

April 23, 2025

2025年4月23日

。

继续阅读

Neuraceq® is an FDA-approved radioactive diagnostic agent for the detection of amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful diagnostic tool for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases..

Neuraceq® 是一种经 FDA 批准的放射性诊断剂，用于检测患有认知障碍的成年患者大脑中的淀粉样蛋白斑块，这些患者正在接受阿尔茨海默病及其他认知衰退病因的评估。Neuraceq® 用于临床常规检查，同时也是对评估治疗资格的患者进行适当特征分析的强大诊断工具，适用于新批准的抗淀粉样蛋白药物或用于神经退行性疾病药物开发的临床试验入组。

Enhanced the supply capabilities of Neuraceq® to increase patient access to beta-amyloid PET imaging.

增强了Neuraceq®的供应能力，以增加患者获取β-淀粉样蛋白PET成像的机会。

Post this

发布这个

'Life Molecular Imaging is pleased to expand the availability of Neuraceq® to

“Life Molecular Imaging 很高兴能够扩大 Neuraceq® 的可用性，

Salt Lake City

盐湖城

, enhancing access for patients and imaging centers in this key region. This expansion reflects LMI's commitment to ensuring broad accessibility to Neuraceq®, reinforcing our dedication to supporting a key step on the pathway to treatment,' said

“，增强了这一关键地区患者和影像中心的获取途径。此次扩展反映了LMI对确保Neuraceq®广泛可及性的承诺，进一步彰显了我们对支持治疗路径上关键一步的决心，”

Colleen Ruby

科琳·鲁比

, US Country Head and Chief Operating Officer, Americas and APAC.

，美国国家负责人兼美洲和亚太地区首席运营官。

About

关于

Neuraceq (florbetaben 18F)

Neuraceq（氟贝塔本 18F）

Indication

指征

Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD.

Neuraceq® 是一种放射性诊断剂，用于对大脑进行正电子发射断层扫描 (PET) 成像，以评估患有认知障碍的成年患者脑内 β-淀粉样蛋白神经炎斑块的密度，这些患者正在接受阿尔茨海默病 (AD) 和其他认知衰退原因的评估。Neuraceq 扫描结果为阴性表明神经炎斑块稀少或不存在，这与图像采集时的阿尔茨海默病神经病理学诊断不一致；阴性扫描结果降低了患者的认知障碍由阿尔茨海默病引起的可能性。

A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition.

Neuraceq扫描结果为阳性，表明存在中度至频繁的淀粉样神经炎斑块；神经病理学检查显示，这种数量的淀粉样神经炎斑块存在于阿尔茨海默病（AD）患者中，但也可能存在于其他神经系统疾病患者以及认知功能正常的老年人中。

Neuraceq is an adjunct to other diagnostic evaluations. .

Neuraceq 是其他诊断评估的辅助手段。

Limitations of Use

使用限制

A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.

Neuraceq® 扫描结果为阳性并不能确诊阿尔茨海默病 (AD) 或其他任何认知障碍。

Safety and effectiveness of Neuraceq have not been established for:

Neuraceq 的安全性和有效性尚未确定：

Predicting development of dementia or other neurologic conditions

预测痴呆症或其他神经系统疾病的发展

Monitoring responses to therapies.

监测对疗法的反应。

Important Safety Information

重要安全信息

Risk for Image Interpretation and Other Errors

图像解读及其他错误的风险

Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors.

在解读Neuraceq图像时，可能会出现对大脑神经炎性β-淀粉样蛋白斑块密度估算的误差。图像解读应独立于患者的临床信息进行。使用临床信息来解读Neuraceq图像尚未经过评估，并可能导致错误。

Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future..

在严重脑萎缩的情况下，可能会限制在Neuraceq扫描中区分灰质和白质的能力，从而导致错误。由于运动伪影导致图像扭曲，也可能发生错误。Neuraceq扫描结果仅在图像采集时表明存在脑神经炎性β-淀粉样蛋白斑块，阴性扫描结果并不能排除未来脑神经炎性β-淀粉样蛋白斑块的发展。

Radiation Risk

辐射风险

Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure..

Neuraceq与其他放射性药物类似，会对患者的整体长期累积辐射暴露有所贡献。长期累积辐射暴露与癌症风险增加相关。确保安全操作，以保护患者和医护人员免受意外的辐射暴露。

Common Adverse Reactions

常见不良反应

The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%)..

Neuraceq 的总体安全性基于对 872 名受试者进行的 1,090 次 Neuraceq 给药数据。尚未报告与 Neuraceq 给药相关的严重不良反应。在使用 Neuraceq 的受试者中，最常见的不良药物反应为注射部位反应，包括红斑 (1.7%)、刺激 (1.1%) 和疼痛 (3.4%)。

For more information please visit: neuraceq.com

有关更多信息，请访问：neuraceq.com

About Life Molecular Imaging (LMI)

关于生命分子成像（LMI）

Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life.

生命分子影像（LMI）是一家国际制药公司，致力于开发和提供用于神经退行性疾病和心血管疾病成像的新型尖端PET放射性药物。该组织力争成为分子影像领域的领导者。我们的使命是开创创新的PET产品，以改善慢性及危及生命的疾病的早期检测和特征分析，从而获得更好的治疗效果并提高生活质量。

By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector.

通过开发用于分子成像的新型PET放射性药物，LMI正专注于现代医学的一个关键领域。LMI是Life Healthcare Group的附属机构——这是一家国际性的以人为本、多元化的医疗保健组织，在南非私营医疗保健领域拥有四十年的经验。

To learn more, please visit .

要了解更多信息，请访问。

https://life-mi.com

。

About Life Healthcare Group

关于生命医疗保健集团

Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern

Life Healthcare是一家以人为核心、多元化的全球医疗保健组织，在约翰内斯堡证券交易所上市。Life Healthcare在南非私营医疗保健领域拥有超过40年的经验，目前在南部地区运营64家医疗机构。

Africa

非洲

. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases.

服务包括急性住院护理、急性物理康复、急性心理健康护理、肾透析、肿瘤学、诊断和分子影像以及健康风险管理服务，其中包括职业健康和保健服务。该集团还拥有Life Molecular Imaging，这是一家专注于开发和全球推广用于PET-CT诊断以检测特定疾病的创新分子影像剂的放射性药物业务。

Visit: .

访问：。

https://www.lifehealthcare.co.za/

https://life-mi.com/

For media queries

对于媒体查询

Brittany Hahn

布列塔尼·哈恩

| Marketing Communications Manager | Life Molecular Imaging

| 市场传播经理 | 生命分子影像

Tel: +1.484.735.2840 |