Beijing, China, October 17, 2023– the Press Conference on the Regulatory Approval of Florbetaben F 18 Injection, organized by Sinotau Pharmaceutical Group, the leading company of innovative radiopharmaceuticals in China, was successfully held in Beijing. Co-President Mrs. Yanmin Tang, Vice President and Secretary of the Board of Directors Mr. Wenbin Yu, Medical Marketing Director Mr.Xin Wang and other senior leaders of the company attended the press conference, and with more than 20 authoritative media to focus on the research and development of Florbetaben F 18 Injection, Alzheimer’s disease diagnostics and other related topics to carry out in-depth exchanges, presenting a medical feast covering the cutting-edge advances in nuclear medicine academia and China’s wisdom.
The First Beta Amyloid PET Imaging Radiotracer in China, Which Can Effectively Solve Clinical Pain Points
As the accelerated population aging in China, the number of AD patients is growing rapidly.A report of the international medical journal The Lancet Public Health (2022) shows that there are currently about 10 million AD patients in China, and it is expected to reach 30 million by 2030.
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 and the core biological marker of AD. Clinical PET-CT/PET-MRI scans are commonly used to estimate the density of β-amyloid neuritic plaque deposition in the brain, thereby facilitating the diagnosis, differential diagnosis, and therapeutic evaluation of AD. Although Aβ-PET imaging has the advantages of early, non-invasive and accurate in the process of AD diagnosis, the PET imaging agent related to AD detection has been in a blank stage in China.
In recent years, the successful development and approval of a number of targeted Aβ therapeutics around the world have also created a large demand gap for Aβ-PET imaging agents, and a number of targeted Aβ therapeutics, including Lecanemab and Donanemab, have used Aβ-PET imaging as a subject screening and study evaluation endpoint.
It is worth rejoicing that on September 15 this year, Sinotau’s Aβ-PET imaging agent, Florbetaben F 18 Injection（with Chines trade name 欧韦宁®）, was approved for marketing by NMPA, becoming the first Aβ-PET imaging radiotracer approved for AD diagnosis in China. According to Mr. Xin Wang, Medical Marketing Director of Sinotau, Florbetaben F 18 is a derivative of diphenylethylene labeled with F-18, which can specifically bind to β-amyloid neuritic plaques in the cortical brain of AD patients. The positron signal generated by the F-18 isotope can be visualized by positron emission tomography (PET) imaging, providing an intuitive display of the presence or absence, and spatial distribution of β-amyloid plaques in the brain.
Talking about the successful approval of Florbetaben F 18, Mrs. Yanmin Tang, Co-President of Sinotau, said at the press conference, “PET imaging radiotracer targeting Aβ is of great significance for the early diagnosis of AD, which has ushered in a new dawn for the majority of AD patients. The approval of Florbetaben F 18 injection will change the long history of no drug available in the field of Aβ-PET diagnostic imaging agent in China, effectively filling the market gap, with important clinical therapeutic value and socio-economic value, and will open a new chapter of AD diagnosis in China.”
Mrs. Yanmin Tang, Co-President of Sinotau
Positive layout of the nuclear drug track to help China’s nuclear medicine development
China’s nuclear medicine started in the 1950s. Although after more than 60 years of development, there is a certain gap between China and developed countries, such as Europe and the United States. With the introduction of heavyweight policies such as the Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035) and the Technical Guidelines for Clinical Evaluation of Radioactive Internal Therapeutic Drugs, nuclear medicine in China is entering a stage of vigorous development.
A clear signal is that in the general environment of the continuous downturn of the innovative drug market, the nuclear medicine track has risen out of the blue, and financing has gone up against the trend. According to statistics, the annual cumulative financing of the nuclear medicine field in 2022 amounted to nearly RMB 900 million, which is the sub-segment track with the highest percentage of over 100 million financing events in the field of innovative drugs. Entering 2023, the heat of the nuclear medicine track continues unabated, and in July this year, Sinotau announced the completion of a new round of financing of more than RMB 1.1 billion, which continues to be used for the research, development and clinical application of diagnostic and therapeutic radiopharmaceuticals. Up to now, the cumulative financing amount of Sinotau exceeds RMB 2 billion, making it the most financed company in China’s nuclear drug field.
Behind the sustained capital favor, it stems from its world-leading research and development resources for precision diagnosis and treatment of nuclear drugs and strong independent research and development capability. According to Mr. Wenbin Yu, Vice President and Secretary of the Board of Directors of Sinotau, Sinotau, as a high-tech enterprise plowing into the field of innovative nuclear drugs, is committed to becoming a total solution provider of radiopharmaceutical research and development, high-quality production, clinical academic promotion as a whole, and has laid out a variety of targeted therapies and precision diagnostic nuclear drugs in the field of oncology, neurology and cardiovascular, and has accumulated rich experience in the research and development, clinical trials, registration and reporting of nuclear drugs, We have accumulated rich experience in nuclear drug research and development, clinical trials, registration and reporting, production, sales and other aspects.
Mr. Wenbin Yu, Vice President and Secretary of the Board of Directors of Sinotau
Mrs. Yanmin Tang, Co-President of Sinotau, said that the successful approval of Florbetaben F 18 means that Sinotau has waded a new path for independent innovation through its own efforts, which will further enhance the competitiveness of the enterprise in the field of nuclear drugs and have a positive impact on the future development of its business. Meanwhile, in the booming development of the domestic nuclear drug field, as an important participant, Sinotau will also contribute to the development of China’s nuclear drug industry.
Mr. Xin Wang, Medical Marketing Director of Sinotau
In the future, Sinotau will continue to plough into the field of nuclear medicine, focus on clinical needs with a patient-centered approach, continuously enhance its independent innovation capability, improve its industrial layout, accelerate the research and development, production and promotion of integrated radio-targeted diagnostic and therapeutic products, so as to better satisfy the growing diagnostic and therapeutic needs of the vast number of patients, and to help the development of China’s nuclear medicine industry for the benefit of the vast number of patients.