{"id":3860,"date":"2023-10-24T11:24:00","date_gmt":"2023-10-24T03:24:00","guid":{"rendered":"http:\/\/www.sinotau.com\/?p=3860"},"modified":"2023-11-30T11:28:02","modified_gmt":"2023-11-30T03:28:02","slug":"life-molecular-imaging-and-sinotau-pharmaceutical-group-announce-the-regulatory-approval-of-their-amyloid-pet-imaging-radiopharmaceutical-neuraceq-in-china","status":"publish","type":"post","link":"http:\/\/www.sinotau.com\/en\/2023\/10\/life-molecular-imaging-and-sinotau-pharmaceutical-group-announce-the-regulatory-approval-of-their-amyloid-pet-imaging-radiopharmaceutical-neuraceq-in-china\/","title":{"rendered":"Life Molecular Imaging and Sinotau Pharmaceutical Group Announce the Regulatory Approval of their Amyloid\u00a0PET\u00a0Imaging Radiopharmaceutical Neuraceq\u00ae in China\u00a0\u00a0"},"content":{"rendered":"\n

Berlin, Germany \/ Beijing, China, October 24, 2023<\/strong> \u2013 Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq\u00ae<\/sup> (with Chinese trade name \u6b27\u97e6\u5b81\u00ae<\/sup>, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China. Neuraceq\u00ae<\/sup> (\u6b27\u97e6\u5b81\u00ae<\/sup>), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting \u03b2-amyloid approved in China to be used to support diagnosis of Alzheimer\u2019s disease (AD).  It visualizes beta-amyloid plaque accumulation in the brain, an established biomarker for AD. Neuraceq\u00ae<\/sup> (\u6b27\u97e6\u5b81\u00ae<\/sup>) will be manufactured by Sinotau and made commercially available. 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.<\/p>\n\n\n\n

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. 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.<\/p>\n\n\n\n

Neuraceq\u00ae<\/sup> 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.<\/p>\n\n\n\n

\u201cWith Neuraceq\u00ae<\/sup> (\u6b27\u97e6\u5b81\u00ae<\/sup>) we are very pleased to bring our amyloid PET tracer, a very important and reliable diagnostic imaging agent, to the Chinese market,\u201d said Dr. Ludger Dinkelborg, Managing Director of Life Molecular Imaging<\/strong>.<\/p>\n\n\n\n

\u201cLMI is committed to expanding global market access of Neuraceq\u00ae<\/sup>. 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\u2019s disease, and to making Neuraceq\u00ae<\/sup> available to referring physicians across the world,\u201d said Colleen Ruby, Chief Operating Officer, Americas and APAC at Life Molecular Imaging.<\/strong><\/p>\n\n\n\n

\u201cNeuraceq\u00ae<\/sup> (\u6b27\u97e6\u5b81\u00ae<\/sup>), an amyloid PET imaging radiotracer which can be imaged through PET-CT\/MRI is the first approved A\u03b2-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\u201d, said Xinsheng Xu, Chairman of Sinotau Pharmaceutical Group<\/strong>.<\/p>\n\n\n\n

About <\/strong>Neuraceq (florbetaben 18F)<\/strong><\/p>\n\n\n\n

Indication approved in the US
<\/strong>Neuraceq\u00ae<\/sup> is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate \u03b2-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer\u2019s 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\u2019s cognitive impairment is due to AD. 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 is an adjunct to other diagnostic evaluations.<\/p>\n\n\n\n

Limitations of Use<\/strong><\/p>\n\n\n\n