Beijing, China, 15 September, 2023?– Sinotau’s radiopharmaceutical product Florbetaben F-18?(with Chinese trade name 歐韋寧?) received regulatory approval from National Medical Products Administration (NMPA) in China.
Florbetaben F 18 injection is a radiotracer used for PET scanning of the brain, which can be used for the diagnosis, differential diagnosis and therapeutic evaluation of AD by determining the level of β-amyloid plaque (commonly known as senile plaques) deposition in the brain.
Florbetaben F 18 injection is the first Aβ-PET imaging radiotracer approved for AD diagnosis in China, which can realize early, accurate and non-invasive AD diagnosis, filling the market gap of Aβ-PET diagnostic imaging agent in AD field in China.
Alzheimer’s Disease Has A Heavy Disease Burden
Alzheimer’s disease (AD) is a neurodegenerative disease characterized by insidious onset and progressive development, encompassing the preclinical, mild cognitive impairment (MCI), and dementia stages. At the preclinical stage, patients usually do not have obvious declines in cognitive function or only show subjective cognitive decline. At the MCI stage, patients begin to Suffer symptoms of cognitive impairments sunch as memory loss. At the dementia stage, patients gradually lose basic daily living abilities. AD severely impacts the physical and mental health and quality of life of middle-aged and elderly individuals, bringing a heavy burden to families and society.
An epidemiologic survey pointed out that there are 9.83 million cases of AD patients aged 60 years and above in China, 49% of AD patients are misdiagnosed as natural aging, and as many as 71.4% and 97.2% of AD and MCI patients do not go to hospitals for treatment. Many of these patients are not diagnosed and treated in a timely manner due to low awareness of the disease among patients and families, and limited screening methods offered by hospitals.
Florbetaben F 18 Injection Helps Early Diagnosis, Early Intervention, Early Benefits for AD Patients
AD has the characteristics of insidious onset and irreversible disease progression. Early diagnosis and intervention of the disease are the key to controlling disease progression.
The abnormal deposition of β-amyloid neuritic plaque in the brain is the earliest pathological change of AD. Abnormal deposition of Aβ can be detected by Aβ-PET 15-20 years before the onset of dementia symptoms. A large IDEAS study enrolling 16,000 subjects showed that diagnosis with Aβ-PET improves diagnostic and therapeutic rates compared to diagnosis without the use of Aβ-PET, and enhances clinical diagnostic confidence.
The Aβ-PET Pharmacoeconomics Study demonstrated that early diagnosis of Aβ-PET effectively reduces healthcare and care costs; significantly shortens the time to clinical confirmation of a patient’s diagnosis, which reduces the risk of admission to the hospital by approximately 12%; and enhances physicians’ confidence in diagnosing the disease, resulting in a positive impact on the clinical care of the patient and on the socioeconomic value of the society.
Mr. Xinsheng Xu, Chairman of Sinotau, said: Florbetaben F 18 Injection can imagine by PET-CT/MRI equipment, and it is the first approved Aβ-PET radiotracer in China, and the first approved PETradiotracer in China in the past two decades. As a new generation force of radiopharmaceuticals in China, Sinotau will continue to innovate in the field of nuclear drugs and accelerate the research and development of urgently needed clinical drugs to better meet the growing clinical needs for diagnosis and treatment of doctors and patients.
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