Sinotau Pharmaceutical Group

NEW YORK, Feb. 6, 2024 /PRNewswire/ -- The radiopharmaceuticals market is expected to increase by USD 4.61 billion, at a CAGR of 10.22% from 2023 to 2027. North America is estimated to contribute 42% to the growth of the global market during the forecast period. The growth is primarily driven by increased investment in research and development within the healthcare sector, notably in the US market. The radiopharmaceutical market has experienced significant expansion, driven by the growing reliance on diagnostics for comprehensive disease identification. "The proven effectiveness of early and precise detection, particularly in chronic conditions like cancer, has heightened the demand for diagnostics employing radioisotopes. Beyond cancer, disorders such as thyroid and cardiology are also increasingly utilizing radiopharmaceuticals, contributing to heightened demand in the region," says a Senior Analyst at Technavio. Continue Reading Technavio has announced its latest market research report titled Global Radiopharmaceuticals Market 2023-2027 Download a Free Sample Report Minimal side effects of radiopharmaceuticals is a key factor driving growth. Radiopharmaceuticals offer significant benefits with few side effects, making them recommended for diagnostic and treatment purposes. Long-term side effects from low-dose exposure are unknown. Rare side effects include soreness, bleeding, and swelling at the injection site. Adverse reactions occur in approximately 1-6 cases per 100,000 injections, with low rates attributed to small drug amounts and localized action. The report provides complete insights on key companies including Bayer AG, Bracco Spa, Cardinal Health Inc., Curium Pharma, Eckert and Ziegler AG, General Electric Co., IBA Radiopharma Solutions, Jubilant Pharma Ltd., Lantheus Holdings Inc., Mallinckrodt Plc, NorthStar Medical Radioisotopes LLC, Novartis AG, NTP Radioisotopes SOC Ltd., PharmaLogic Holdings Corp., Positron Corp., Radiomedix Inc., Siemens AG, Sinotau Pharmaceuticals, Telix Pharmaceuticals Ltd., and Sotera Health Co. Download a Free Sample Report The competitive scenario provided in the report analyzes, evaluates, and positions companies based on various performance indicators. Some of the factors considered for this analysis include the financial performance of companies over the past few years, growth strategies, product innovations, new product launches, investments, growth, etc. By Source, the market is classified into cyclotrons and nuclear reactors. The growth of the cyclotrons segment will be significant during the forecast period. A cyclotron is a particle accelerator that uses electromagnetic fields to accelerate charged particles to high speeds and energies. It is used to produce radioisotopes for radiopharmaceuticals, which are widely used in cancer diagnosis and treatment. Cyclotrons are advancing rapidly and are crucial in healthcare for their efficient production of radiopharmaceuticals, particularly in advanced cancer imaging. Subscribe Now Radiopharmaceuticals play a crucial role in nuclear medicine Radiopharmaceuticals play a crucial role in nuclear medicine, where they are used for both diagnostic imaging and therapeutic purposes. These pharmaceuticals contain radioactive tracers that enable medical imaging techniques like positron emission tomography (PET) and single-photon emission computed tomography (SPECT). In diagnostics, radiopharmaceuticals help visualize internal structures and functions, aiding in the detection of diseases such as cancer and cardiovascular conditions. Therapeutic radiopharmaceuticals are used in targeted radionuclide therapy for cancer treatment. The production of these radioisotopes is essential for medical applications, and ongoing developments in radiochemistry and radiopharmaceutical development contribute to advancing diagnostic accuracy and treatment efficacy. The nuclear medicine market is influenced by trends in isotope production, innovative imaging agents, and the broader field of molecular imaging. Related Report The global plasma protease C1 inhibitor market size is estimated to grow by USD 2.00 billion, at a CAGR of 7.55% between 2023 and 2028. The Global Nuclear Medicine Market size is estimated to grow by USD 8,057.89 million at a CAGR of 16.48% between 2022 and 2027. ToC: Executive Summary Market Landscape Market Sizing Historic Sizes Five Forces Analysis Segmentation by Source Segmentation by End-user Segmentation by Geography Customer Landscape Geographic Landscape Drivers, Challenges, & Trends Company Landscape Company Analysis Appendix About US Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging trends and provide actionable insights to help businesses identify opportunities and develop effective strategies to optimize their positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable insights to identify opportunities in existing and potential areas and assess their competitive positions within changing scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

First Amyloid PET Tracer Received Regulatory Approval in China BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- 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. About Neuraceq (florbetaben 18F) Indication approved in the US 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. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions, or (ii) monitoring responses to therapies. Important Safety Information (as approved in the US) Risk for Image Interpretation and Other Errors Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future. Radiation Risk Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Common Adverse Reactions The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. Adverse Reactions occurring with a frequency of more than 1% include injection/application site erythema, injection site irritation and injection site pain. For more information please visit: About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Life Healthcare Group. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit . About Sinotau Pharmaceutical Group Sinotau is an innovative radiopharmaceutical company located in China and developing globally. Since 2014, Sinotau started the research and development of targeted radiopharmaceuticals. Headquartered in Beijing, China, has modern radiopharmaceutical intelligent production sites in Jiangsu, Guangdong, and Sichuan, an early discovery center in Shanghai, and a branch in the United States. Sinotau has taken the lead in deploying a portfolio of targeted therapies and precision diagnostic radiopharmaceuticals in the fields of tumors, neurodegenerative diseases, and cardiovascular diseases. More than 20 novel product pipelines are in different development stages. Sinotau looks into the future following the company's mission "invent radiopharmaceuticals for lives", and through continued investments in R&D to help improve the quality of life of patients and to contribute to China's radiopharmaceutical sector. Visit About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, an R&D molecular imaging business of innovative PET tracers to reduce the burden of diseases through improved early detection. Learn more at For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 | SOURCE Life Molecular Imaging

Agreement with Sinotau Pharmaceutical Group part of Company’s global strategy to increase clinician and patient access to innovative diagnostic imaging agent OXFORD, England & MONROE TOWNSHIP, N.J.--(BUSINESS WIRE)-- Blue Earth Diagnostics Ltd, a Bracco company and recognised leader in the development and commercialisation of innovative PET radiopharmaceuticals, announced that it has signed an exclusive strategic agreement with Sinotau Pharmaceutical Group for the positron emission tomography (PET) imaging agent flotufolastat (18F) injection (formerly referred to as 18F-rhPSMA-7.3) in prostate cancer. Under the terms of the agreement this will be a close strategic partnership, with ongoing technology and regulatory support, aiming to support the use of flotufolastat (18F) for men with prostate cancer in China. It marks an important stage in the Blue Earth Diagnostics’ strategy to make flotufolastat (18F) available to patients and clinicians globally. The introduction of flotufolastat (18F) has the potential to fill a significant gap in the Chinese domestic market where there are currently no 18F-labeled PSMA-PET diagnostic radiopharmaceuticals available. This could provide new solutions and options for the diagnosis and treatment of prostate cancer in China, where there is a growing need for clinicians and patients to have access to the latest advancements. In recent years, the incidence of prostate cancer in China has shown a significant upward trend. Although the incidence of prostate cancer is lower than in Western countries, the proportion of patients with advanced stage disease at diagnosis is higher. The "2022 Prostate Cancer Diagnosis and Treatment Guidelines" recommended by the Chinese Society of Clinical Oncology (CSCO) suggest that PSMA-PET can be used to assess prostate cancer patients undergoing definitive treatment, including surgery, diagnosis and location of biochemical recurrence after radical surgery or radiotherapy, and evaluation of systemic treatment efficacy and long-term follow-up. Yanmin Tang, CEO of Sinotau Pharmaceutical Group, said, “Sinotau Pharmaceutical Group is dedicated to the field of new generation radiopharmaceuticals. We are pleased to form this strategic cooperation with Blue Earth Diagnostics and we look forward to making flotufolastat (18F) available to the clinical community in China. In the future, Sinotau Pharmaceutical Group will continue to make clinically valuable and excellent radiopharmaceuticals available to benefit more Chinese patients.” Matt Morrison. Ph.D., Head of Operations and Supply Chain, at Blue Earth Diagnostics said, “Partnering with experienced companies such as Sinotau supports our strategic focus on PET imaging in cancer, with the goal to provide global solutions for the informed treatment of prostate cancer patients, something that we could not accomplish alone. We look forward to working together with our colleagues at Sinotau with the aim to successfully bring flotufolastat (18F) to clinicians and their patients in China.” “We are delighted to have this new agreement in place with Sinotau, to make innovative flotufolastat (18F) PET imaging available to the Chinese community,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “Flotufolastat (18F) represents a new class of PSMA-targeted PET radiopharmaceuticals that are based on novel radiohybrid technology. It is engineered to advance clinical decision-making by providing useful information to guide treatment planning in men with prostate cancer. We believe that the demonstrated diagnostic performance of flotufolastat (18F), with its high-affinity PSMA binding and low urinary bladder activity, make it a valuable diagnostic tool for markets around the world.” About Flotufolastat (18F) Flotufolastat (18F) (formerly referred to as 18F-rhPSMA-7.3) is an optimised, targeted radiohybrid diagnostic imaging agent that is approved in the United States, where it is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Precision PET imaging with flotufolastat (18F) can help identify the location and extent of prostate cancer, providing clinically valuable information to guide patient management. Flotufolastat (18F) represents a new class of high-affinity PSMA-targeted PET radiopharmaceuticals that are based on novel radiohybrid technology and is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease. Flotufolastat (18F) was approved by the U.S. Food and Drug Administration in May 2023. About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalised by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval. About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialisation of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialisation of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . About Sinotau Sinotau is an innovative radiopharmaceutical company located in China and developing globally. Since 2014, Sinotau started the research and development of targeted radiopharmaceuticals. Headquartered in Beijing, China, Sinotau has modern radiopharmaceutical intelligent production sites in Jiangsu, Guangdong, and Sichuan, an early discovery center in Shanghai, and a branch in the United States. Sinotau has taken the lead in deploying a portfolio of targeted therapies and precision diagnostic radiopharmaceuticals in the fields of tumors, neurodegenerative diseases, and cardiovascular diseases. More than 20 novel product pipelines are in different development stages. Sinotau looks into the future following the company's mission "invent radiopharmaceuticals for lives", and through continued investments in R&D to help improve the quality of life of patients and to contribute to China's radiopharmaceutical sector. PP-UK-0668 October 2023 View source version on businesswire.com: Contacts For Blue Earth Diagnostics (UK) Clare Gidley Associate Director Marketing and Communications +44 (0) 7917 536939 clare.gidley@blueearthdx.com For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice President, Corporate Communications (781) 799-7917 priscilla.harlan@blueearthdx.com Media Sam Brown Inc. Mike Beyer (312) 961-2502 mikebeyer@sambrown.com Source: Blue Earth Diagnostics Ltd View this news release online at: