Sinotau Pharmaceutical Group and Blue Earth Diagnostics Ltd collaborate on an agreement to bring an innovative PSMA-targeted PET imaging agent to China, paving the way for integrated tumor theranostics
BEIJING, China, 17 October 2023 - Sinotau Pharmaceutical Group and the British molecular imaging company Blue Earth Diagnostics Ltd are announcing an exclusive strategic agreement for the development, production, and commercialization of the innovative PSMA-targeted PET imaging agent flotufolastat (18F) in China.
Flotufolastat (18F) is an optimized positron emission tomography (PET) imaging agent designed to target prostate-specific membrane antigen (PSMA) positive lesions, indicated in the United States (U.S.) for 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.
The introduction of flotufolastat (18F) to China has the potential to fill a significant gap in the domestic market where there are currently no similar products, particularly 18F-labeled PSMA-PET diagnostic radiopharmaceuticals, available. This could provide new solutions and improved options for the management of prostate cancer patients in China.
In recent years, the incidence of prostate cancer in China has shown a significant upward trend. According to statistics and predictions from the International Agency for Research on Cancer of the World Health Organization, the incidence of prostate cancer in China in 2020 was about 15.6/100,000 people, with more than 110,000 new cases and over 50,000 deaths. The incidence of prostate cancer in first-tier cities is even higher with Beijing, Shanghai, and Guangzhou reporting rates of 19.30, 32.23, and 17.57 per 100,000 people respectively. Prostate cancer ranks sixth among male malignant tumors and is responsible for approximately 31,000 deaths each year, ranking tenth among male malignant tumors.
Prostate cancer typically progresses slowly and presents no obvious symptoms in its early stages. However, once metastasis occurs, the disease becomes more aggressive, making it difficult for clinicians to manage. As such, "early screening, diagnosis, and treatment" is one of the effective ways to improve the 5-year survival rate of prostate cancer patients.
Prostate-specific membrane antigen, or PSMA, is a type II transmembrane glycoprotein encoded by the folate hydrolase gene. While PSMA is only physiologically expressed in normal prostate tissue, it is overexpressed in prostate cancer cells at all stages. The degree of PSMA expression is correlated with tumor staging and grading.
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 guide the selection of biopsy sites for prostate cancer patients, preoperative evaluation of patients undergoing surgery, diagnosis and evaluation of biochemical recurrence after radical surgery or radiotherapy, targeting of local radiotherapy for non-metastatic prostate cancer, evaluation of systemic treatment efficacy, and long-term follow-up.
Despite the growing need for advanced diagnostic tools, there are currently no PSMA-PET products available on the market in China. This has left clinicians and patients without access to the latest advancements in prostate cancer detection and treatment.
Flotufolastat (18F), developed by British company Blue Earth Diagnostics, offers a potential solution to this problem. Approved by the US Food and Drug Administration (FDA) in May 2023, flotufolastat (18F) is an optimized, 18F-labeled targeted radiohybrid diagnostic imaging agent. 18F has suitable physical properties for PET imaging, a durable half-life, and a convenient clinical application process.
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 potential for low urinary bladder activity, make it a valuable diagnostic tool for markets around the world."
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.
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 commercialization 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 commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.
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: www.braccoimaging.com.