First Amyloid PET Tracer Received Regulatory Approval in China

第一个淀粉样蛋白PET示踪剂在中国获得监管部门批准

BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China.

柏林和北京，2023年10月24日/PRNewswire/-生命分子成像（LMI）和Sinotau制药集团很高兴宣布Neuraceq®（中文商标）欧韦宁®，florbetaben F-18注射液）已获得中国国家医疗产品管理局（NMPA）的监管批准。

Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer's disease (AD). It visualizes beta-amyloid plaque accumulation in the brain, an established biomarker for AD. Neuraceq® (欧韦宁®) will be manufactured by Sinotau and made commercially available.

Neuraceq®(欧韦宁®）是一种淀粉样蛋白PET成像放射性示踪剂，是中国批准用于支持阿尔茨海默病（AD）诊断的第一种靶向β-淀粉样蛋白的放射性药物。它可视化大脑中β-淀粉样斑块的积累，这是AD.Neuraceq®的既定生物标志物(欧韦宁®）将由Sinotau制造并可商购。

With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline. The density of amyloid plaques can be assessed to guide early diagnosis and patient management..

有了这个诊断工具，中国医生将可以使用最先进的成像技术来准确评估认知能力下降的患者。可以评估淀粉样斑块的密度，以指导早期诊断和患者管理。。

After recent approvals in the US, promising disease modifying drugs for AD are on the horizon in China. Early and reliable diagnosis of AD is critical for successful patient management and access to future therapies. Amyloid PET has a pivotal role in the positive clinical study outcomes for new AD drugs such as lecanemab and donanemab, by making selective inclusion of patients with confirmed amyloid pathology in the brain in the trials feasible.

在最近获得美国批准后，中国有希望用于AD的疾病缓解药物即将出现。AD的早期可靠诊断对于成功的患者管理和获得未来治疗至关重要。淀粉样蛋白PET在新的AD药物如lecanemab和donanemab的阳性临床研究结果中具有关键作用，通过在试验中选择性地纳入脑中具有确认的淀粉样蛋白病理学的患者是可行的。

Moreover, amyloid clearance was precisely measured with amyloid PET. Sinotau plans to prioritize setup of radiopharmaceutical sites in Jiangsu, Guangdong, and Sichuan provinces, to ensure product distribution to the majority of the Chinese market. All sites will meet requirements for GMP standards..

此外，用淀粉样蛋白PET精确测量淀粉样蛋白清除率。Sinotau计划优先在江苏，广东和四川省建立放射性药物站点，以确保产品向中国大部分市场分销。所有站点都将满足GMP标准的要求。。

Neuraceq® has previously been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom and competent health authorities in other territories.

Neuraceq®之前已获得美国食品和药物管理局（FDA），欧洲药品管理局（EMA），英国药品和保健品监管局（MHRA）以及其他地区的主管卫生当局的批准。

'With Neuraceq® (欧韦宁®) we are very pleased to bring our amyloid PET tracer, a very important and reliable diagnostic imaging agent, to the Chinese market,' said Dr. Ludger Dinkelborg, Managing Director of Life Molecular Imaging.

'与Neuraceq®(欧韦宁®）我们非常高兴将我们的淀粉样蛋白PET示踪剂（一种非常重要且可靠的诊断成像剂）带入中国市场，“Life Molecular imaging总经理Ludger Dinkelborg博士说。

'LMI is committed to expanding global market access of Neuraceq®. We will continue to partner with local distributors like Sinotau to improve the diagnosis of patients being evaluated for mild cognitive impairment (MCI) and Alzheimer's disease, and to making Neuraceq® available to referring physicians across the world,' said Colleen Ruby, Chief Operating Officer, Americas and APAC at Life Molecular Imaging..

'LMI致力于扩大Neuraceq®的全球市场准入。首席运营官Colleen Ruby说，我们将继续与像Sinotau这样的当地分销商合作，改善被评估为轻度认知障碍（MCI）和阿尔茨海默病的患者的诊断，并为世界各地的转诊医生提供Neuraceq®。，美洲和APAC在生命分子成像方面。。

'Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer which can be imaged through PET-CT/MRI is the first approved Aβ-PET tracer in China and the first approved PET tracer in China in recent 20 years. As a strong new generation provider in the field of radiopharmaceuticals in China, Sinotau will continue to contribute to innovation in radiopharmaceuticals, accelerate the research and development of urgently needed clinical drugs to better meet the growing clinical needs for diagnosis and treatment,' said Xinsheng Xu, Chairman of Sinotau Pharmaceutical Group..

'Neuraceq®(欧韦宁®），可通过PET-CT/MRI成像的淀粉样蛋白PET成像放射性示踪剂是中国首个获得批准的Aβ-PET示踪剂，也是近20年来中国首个获得批准的PET示踪剂。作为中国放射性药物领域的强大新一代供应商，Sinotau将继续为放射性药物的创新做出贡献，加速急需临床药物的研发，以更好地满足日益增长的临床诊断和治疗需求。徐新生表示，新头制药集团主席。。

About Neuraceq (florbetaben 18F)

关于Neuraceq（florbetaben 18F）

Indication approved in the US

在美国批准的指示

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，适用于大脑的正电子发射断层扫描（PET）成像，用于评估正在评估阿尔茨海默病（AD）和其他认知衰退原因的认知障碍成年患者的β-淀粉样神经炎斑块密度。Neuraceq扫描阴性表明稀疏至无神经炎斑块，并且与图像采集时AD的神经病理学诊断不一致；阴性扫描结果降低了患者认知障碍归因于AD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扫描阳性表明中度至频繁的淀粉样神经炎斑块；神经病理学检查显示AD患者存在这种数量的淀粉样神经炎斑块，但也可能存在于患有其他类型神经系统疾病的患者以及认知正常的老年人中。

Neuraceq is an adjunct to other diagnostic evaluations. .

Neuraceq是其他诊断评估的辅助工具。 .

Limitations of Use

使用限制

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

阳性Neuraceq®扫描不能确定AD或任何其他认知障碍的诊断。

Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions, or (ii) monitoring responses to therapies.

尚未建立Neuraceq®的安全性和有效性，用于（i）预测痴呆或其他神经系统疾病的发展，或（ii）监测对治疗的反应。

Important Safety Information (as approved in the US)

重要的安全信息（经美国批准）

Risk for Image Interpretation and Other ErrorsErrors 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. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan.

图像解释和其他错误错误的风险可能发生在图像解释期间脑神经炎β-淀粉样斑块密度的Neuraceq估计中。图像解读应独立于患者的临床信息进行。严重脑萎缩的情况也可能出现错误，这限制了Neuraceq扫描区分灰质和白质的能力。

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..

由于导致图像失真的运动伪影，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β-淀粉样斑块，阴性扫描结果并不排除将来脑神经炎β-淀粉样斑块的发展。。

Radiation RiskNeuraceq, 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..

辐射风险Neuraceq与其他放射性药物类似，有助于患者的整体长期累积辐射暴露。长期累积辐射暴露与癌症风险增加有关。确保安全处理，以保护患者和医护人员免受意外辐射照射。。

Common Adverse Reactions The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. Adverse Reactions occurring with a frequency of more than 1% include injection/application site erythema, injection site irritation and injection site pain.

常见不良反应Neuraceq的总体安全性基于1090次Neuraceq给药至872名受试者的数据。发生频率超过1%的不良反应包括注射/施用部位红斑，注射部位刺激和注射部位疼痛。

For more information please visit: https://neuraceq.com

欲了解更多信息，请访问：https://neuraceq.com

About Life Molecular Imaging (LMI)Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Life Healthcare Group. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine.

关于生命分子成像（LMI）生命分子成像（LMI，以前称为Piramal Imaging）成立于2012年，收购了拜耳制药公司的分子成像研究与开发组合。现在它已成为生命医疗集团的一部分。通过开发用于分子成像的新型PET示踪剂，LMI专注于现代医学的关键领域。

The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit https://life-mi.com..

该组织通过开发创新产品，努力成为分子成像领域的领导者，这些产品可改善慢性和危及生命的疾病的早期发现和表征，从而带来更好的治疗效果和改善的生活质量。请访问https://life-mi.com..

About Sinotau Pharmaceutical GroupSinotau is an innovative radiopharmaceutical company located in China and developing globally. Since 2014, Sinotau started the research and development of targeted radiopharmaceuticals. Headquartered in Beijing, China, has modern radiopharmaceutical intelligent production sites in Jiangsu, Guangdong, and Sichuan, an early discovery center in Shanghai, and a branch in the United States.

关于Sinotau Pharmaceutical Group Sinotau是一家位于中国并在全球发展的创新型放射性制药公司。自2014年以来，Sinotau开始研究和开发靶向放射性药物。总部设在中国北京，在江苏，广东和四川拥有现代放射性药物智能生产基地，在上海是一个早期发现中心，在美国有一个分支机构。

Sinotau has taken the lead in deploying a portfolio of targeted therapies and precision diagnostic radiopharmaceuticals in the fields of tumors, neurodegenerative diseases, and cardiovascular diseases. More than 20 novel product pipelines are in different development stages. Sinotau looks into the future following the company's mission 'invent radiopharmaceuticals for lives', and through continued investments in R&D to help improve the quality of life of patients and to contribute to China's radiopharmaceutical sector..

Sinotau率先在肿瘤，神经退行性疾病和心血管疾病领域部署了一系列靶向治疗和精确诊断放射性药物。超过20条新产品管道处于不同的开发阶段。Sinotau遵循公司“为生命发明放射性药物”的使命，并通过继续投资研发帮助改善患者的生活质量并为中国的放射性药物行业做出贡献，展望未来。。

Visit https://www.sinotau.com/

Visit https://www.sinotau.com/

About Life Healthcare GroupLife Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa.

关于Life Healthcare Group Life Healthcare是约翰内斯堡证券交易所上市的全球性以人为本，多元化的医疗机构。Life Healthcare在南非私营医疗部门拥有超过38年的经验，目前在南部非洲设有64家医疗机构。

Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, an R&D molecular imaging business of innovative PET tracers to reduce the burden of diseases through improved early detection.

服务包括急性医院护理，急性身体康复，急性精神保健，肾透析，肿瘤学，影像学和职业健康与保健服务。该集团还拥有创新型PET示踪剂研发分子成像业务Life Molecular Imaging，通过改进早期检测来减轻疾病负担。

Learn more at https://www.lifehealthcare.co.za/.

了解更多信息，请访问https://www.lifehealthcare.co.za/.

For media queriesBrittany Hahn | Marketing Communications Manager | Life Molecular ImagingTel: +1.484.735.2840 |

媒体queriesBrittany Hahn |营销沟通经理| Life Molecular ImagingTel:+1.484.735.2840|

SOURCE Life Molecular Imaging

源生命分子成像