Germany-headquartered Life Molecular Imaging (LMI) and China-based Sinotau Pharmaceutical Group have announced that Neuraceq (florbetaben F-18 injection) has received regulatory approval from the National Medical Products Administration (NMPA) in China. This marks a significant milestone as Neuraceq becomes the first radiopharmaceutical targeting β-amyloid approved in China to support the diagnosis of Alzheimer’s disease (AD).
Neuraceq: Indication and Global Approvals
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. The drug has previously garnered approvals from the US FDA, the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, and other health authorities globally.
Sinotau’s Market Strategy
Sinotau plans to prioritize the setup of radiopharmaceutical sites in Jiangsu, Guangdong, and Sichuan provinces to ensure product distribution to the majority of the Chinese market. These sites will adhere to Good Manufacturing Practice (GMP) standards, ensuring the quality and safety of Neuraceq for patients across China.-Fineline Info & Tech
