First amyloid PET tracer received regulatory approval in China
BERLIN and BEIJING, October 24, 2023 /PRNewswire/ — Molecular imaging of life (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (under the Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from the National Medical Products Administration (NMPA) in China. Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first β-amyloid targeting radiopharmaceutical approved in China for use to support the diagnosis of Alzheimer’s disease (AD). It visualizes the accumulation of beta-amyloid plaque in the brain, an established biomarker for AD. Neuraceq® (欧韦宁®) will be manufactured by Sinotau and made commercially available. With this diagnostic tool, Chinese doctors will have access to cutting-edge imaging technology to accurately assess patients with cognitive decline. Amyloid plaque density can be assessed to guide early diagnosis and patient management.
After recent approvals in the United States, promising disease-modifying drugs for AD are on the horizon in China. Early and reliable diagnosis of AD is essential for successful patient care and access to future treatments. Amyloid PET plays a central role in the positive results of clinical studies of new AD drugs such as lecanemab and donanemab, making possible the selective inclusion of patients with confirmed amyloid pathology in the brain in the trials. Additionally, amyloid clearance was accurately measured with amyloid PET. Sinotau plans to prioritize the establishment of radiopharmaceutical sites in Jiangsu, Guangdong and Sichuan provinces, to ensure product distribution to the majority of the Chinese market. All sites will meet the requirements of GMP standards.
Neuraceq® has already been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and authorities competent health authorities from other territories.
“With Neuraceq® (欧韦宁®), we are very pleased to introduce 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.
“LMI Committed to Expanding Neuraceq’s Global Market Access®. We will continue to collaborate with local distributors like Sinotau to improve the diagnosis of patients being evaluated for mild cognitive impairment (MCI) and Alzheimer’s disease, and to manufacture Neuraceq® available to referring physicians around the world,” said Colleen Ruby, Director of Operations, Americas and APAC at Life Molecular Imaging.
“Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer that can be imaged by PET-CT/MRI is the first Aβ-PET tracer approved in China and the first PET tracer approved in China in the past 20 years. As a strong next-generation supplier in the field of radiopharmaceuticals in China, Sinotau will continue to contribute to innovation in the field of radiopharmaceuticals, accelerate the research and development of urgent clinical drugs to better meet the growing clinical needs in diagnosis and treatment,” said Xinsheng Xu, chairman of Sinotau Pharmaceutical Group.
About Neuraceq (florbetaben 18F)
Indication approved in the United States
Neuraceq® is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain to estimate the density of β-amyloid neuritic plaques in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease. Alzheimer’s (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates few or no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative test result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; Neuropathological examination showed that this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurological disorders as well as in older adults with normal cognition. Neuraceq is a complement to other diagnostic assessments.
Usage Limits
- A positive Neuraceq® the analysis does not establish the diagnosis of AD or any other cognitive disorder.
- Safety and effectiveness of Neuraceq® have not been established to (i) predict the development of dementia or other neurological disorders, or (ii) monitor responses to therapies.
Important Safety Information (as approved in the United States)
Risk of image interpretation and other errors
Errors may occur in the Neuraceq estimate of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. Errors can also occur in cases of severe brain atrophy that limits the ability to distinguish gray matter from white matter on the Neuraceq scanner. Errors can also occur due to motion artifacts leading to image distortion. The results of the Neuraceq analysis indicate the presence of cerebral senile β-amyloid plaques only at the time of image acquisition and a negative analysis result does not exclude the development of cerebral senile β-amyloid plaques at the time of image acquisition. ‘future.
Radiation risk
Neuraceq, like other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Cumulative long-term radiation exposure is associated with increased cancer risk. Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure.
Common side effects
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 greater than 1% include injection/application site erythema, injection site irritation, and injection site pain.
For more information, please visit: https://neuraceq.com
About molecular imaging of life (IMT)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was established 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 new PET tracers for molecular imaging, LMI is focusing on a key area of modern medicine. The organization strives to be a leader in the field of molecular imaging by developing innovative products that improve the early detection and characterization of chronic and life-threatening diseases, thereby leading to improved therapeutic outcomes and better quality of life. Please visit https://life-mi.com.
About the Sinotau pharmaceutical group
Sinotau is an innovative radiopharmaceutical company located in China and developing globally. Since 2014, Sinotau has started the research and development of targeted radiopharmaceutical products. Headquartered in Beijing, China, the company has intelligent and modern radiopharmaceutical production sites in Jiangsu, Guangdong and Sichuan, a premier discovery center in Shanghai and a branch office in the United States. Sinotau has taken the lead in deploying a portfolio of targeted therapies and precision diagnostic radiopharmaceuticals in the areas of tumors, neurodegenerative diseases and cardiovascular diseases. More than 20 new product pipelines are in various stages of development. Sinotau looks to the future by following the company’s mission of “inventing radiopharmaceuticals for life” and continuing to invest in R&D to help improve patients’ quality of life and contribute to China’s radiopharmaceutical industry.
Visit https://www.sinotau.com/
About Life Healthcare Group
Life Healthcare is a diversified, people-focused global healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years of experience in the private healthcare sector in South Africa and currently operates 64 healthcare facilities across Southern Africa. Services include acute hospital care, acute physical rehabilitation services, acute mental health care, kidney dialysis services, oncology, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, a molecular imaging R&D business of innovative PET tracers aimed at reducing the burden of disease through improved early detection. Learn more about https://www.lifehealthcare.co.za/
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SOURCE Molecular Imaging of Life