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. 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. 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.

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.

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.

"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.

"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.

"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.