Life Molecular Imaging and Sinotau Pharmaceutical Group Announce Regulatory Approval for Amyloid PET Imaging Radiopharmaceutical Neuraceq® in China

Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are thrilled to announce that Neuraceq® (known as Owenin® in Chinese, florbetaben F-18 injection) has obtained regulatory approval from the National Medical Products Administration (NMPA) in China. Neuraceq® (Owenin®) is an amyloid PET imaging radiotracer, representing a significant milestone as the first radiopharmaceutical designed to target β-amyloid to support the diagnosis of Alzheimer's disease (AD) in China. It plays a crucial role in visualizing the accumulation of beta-amyloid plaques in the brain, a well-established biomarker for AD. Sinotau will handle the manufacturing of Neuraceq® (Owenin®) and make it available for commercial use. This development equips Chinese physicians with state-of-the-art imaging technology to accurately assess patients experiencing cognitive decline, allowing for the assessment of amyloid plaque density to facilitate early diagnosis and patient management.

Following 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 effective patient management and access to future therapies. Amyloid PET imaging has played a pivotal role in achieving positive clinical study outcomes for new AD drugs like lecanemab and donanemab, as it enables the selective inclusion of patients with confirmed amyloid pathology in the brain. Furthermore, it allows for the precise measurement of amyloid clearance. Sinotau plans to prioritize the establishment of radiopharmaceutical facilities in Jiangsu, Guangdong, and Sichuan provinces, ensuring broad product distribution across the Chinese market, all of which will adhere to Good Manufacturing Practice (GMP) standards.

Neuraceq® has previously received approval from 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 regions.

Life Molecular Imaging, expressed, "With Neuraceq® (Owenin®), we are very pleased to bring our amyloid PET tracer, a very important and reliable diagnostic imaging agent, to the Chinese market."

Life Molecular Imaging, emphasized LMI's commitment to expanding global access to Neuraceq® and partnering with local distributors like Sinotau to enhance the diagnosis of patients being evaluated for mild cognitive impairment (MCI) and Alzheimer's disease, making Neuraceq® accessible to referring physicians worldwide.

Sinotau Pharmaceutical Group, commented, "Neuraceq® (Owenin®), 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 the past 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."

Neuraceq® is a radioactive diagnostic agent intended for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment undergoing evaluation for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan suggests sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of the scan. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; such plaques are present in patients with AD, although they may also be found in patients with other neurologic conditions and in older individuals with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder. Additionally, the safety and effectiveness of Neuraceq® for predicting the development of dementia or other neurologic conditions, as well as for monitoring responses to therapies, have not been established.

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