BEIJING, China – September 8, 2025 – Beijing Sinotau International Pharmaceutical Technology Co., Ltd. (“Sinotau”) is proud to announce that the Phase I, first-in-human study of self-developed innovative radiopharmaceutical XTR004, were awarded the Best Translational Paper Award – Molecular Imaging Category by the Journal of Nuclear Cardiology at the 30th Annual Scientific Session and Exhibition of the American Society of Nuclear Cardiology (ASNC 2025).
Marcelo F. Di Carli, the editor-in-chief of JNC, stated: “The ‘Best Translational Paper Award – Molecular Imaging Category’ recognizes the molecular imaging agent accepted for publication in 2024 with the highest potential for clinical application. XTR004, as one of the awardees, is expected to significantly impact the diagnosis, efficacy evaluation, and prognosis of patients with cardiovascular diseases in the future.”
Peking Union Medical College Hospital, as the principal site of this clinical study, systematically evaluated the biodistribution, radiation dosimetry, pharmacokinetics, and safety of XTR004 after a single injection at rest. This prestigious international award reflects the high recognition from the global academic community for the innovation and clinical value of XTR004, as well as its significant potential in addressing unmet clinical needs.
XTR004 is a 18F-labeled mitochondrial complex I-targeted innovative diagnostic radioligand for PET-MPI. It is designed to detect myocardial ischemia caused by flow-limiting stenoses in epicardial arteries and/or coronary microvascular dysfunction(CMD). Sinotau has completed a Phase I clinical trial and a Phase II clinical trial of XTR004 in China and plans to initiate a Phase III trial in the fourth quarter of 2025.
According to CIC, due to a variety of environmental and habitual risk factors such as air pollution, obesity, hypertension, and unhealthy lifestyles, coupled with the accelerated population aging, the number of CAD patients globally and in China amounted to 316.6 and 11.5 million, respectively, in 2024. CAD is the third leading cause of mortality in China and the leading cause of mortality worldwide. Early detection and diagnosis are critical to reducing the risk of myocardial infarction and lowering CAD-related mortality. MPI is widely recognized as an important and evidence-based non-invasive functional testing method for diagnosing myocardial ischemia. Compared to other diagnostic methods (including SPECT-MPI, coronary CTA, and coronary angiography), XTR004, as a PET-MPI tracer, offers significant clinical benefits. These include substantially shorter imaging time allowing for single-day protocols, higher sensitivity and accuracy in detecting myocardial ischemia in multivessel disease and microvascular dysfunction, thereby better informing coronary heart disease treatment decisions. Its non-invasive nature can also greatly improve patient compliance. Completed clinical trials have demonstrated the excellent safety and diagnostic performance of XTR004. As the first and only PET-MPI tracer currently under clinical development in China, We believe XTR004 can provide clinicians with a more accurate and reliable method for diagnosing myocardial ischemia and guiding treatment decisions.
Dr. Bailing Hsu, Chief Scientific Officer of Sinotau, stated: “We are deeply honored to receive this prestigious award from ASNC. This is not only an international recognition of the scientific value of Sinotau’s XTR004 project and our team’s innovative capabilities but also an encouragement for Chinese biopharmaceutical companies committed to original innovation. We will accelerate the subsequent clinical development of this product, striving to bring this innovative achievement to benefit patients worldwide as soon as possible.”
As a leading innovative radiopharmaceutical company in China, Sinotau always adheres to its mission of “Invent radiopharmaceuticals for lives”. In the future, Sinotau will continue to focus on the innovation and translation of radiopharmaceuticals, promoting more innovative achievements into clinical practice and application, enabling more patients to benefit from cutting-edge medical advancements early.
About ASNC
ASNC is the international home for nuclear cardiology and the only professional society devoted exclusively to the field. Cardiologists, radiologists, physicians, scientists, technologists, imaging specialists, and other professionals work together to improve cardiovascular outcomes through image-guided patient management. ASNC’s more than 5,700 members represent the top experts in the field and, as a result, ASNC consistently serves as a leading voice in education, research, quality standards and guidelines, and advocacy in cardiovascular imaging.
Since its inception in 1993, ASNC has remained committed to its mission to improve cardiovascular outcomes through image-guided patient management and vision to be the preeminent voice and resource of nuclear cardiology. For more details, please see https://www.asnc.org/about-asnc/
About Sinotau
Sinotau, founded in 2005, is a front-runner and leader in the Chinese radiopharmaceutical market, possessing end-to-end capabilities across the entire industry value chain, from radionuclide development and production to radiopharmaceutical R&D, manufacturing, and commercialization. Adhering to its mission of “Invent radiopharmaceuticals for lives”, Sinotau is rooted in China with a global vision. The company is headquartered in Beijing, with an R&D center in Shanghai, and modern radiopharmaceutical production bases in Jiangsu, Guangdong, and Sichuan; it also has a branch in the United States. Driven by unmet clinical needs, Sinotau focuses on three major therapeutic areas: neurodegenerative diseases, cardiovascular diseases, and oncology, having established a comprehensive, differentiated, and synergistic product portfolio with significant potential in radiopharmaceutical theranostics. Among its products, Florbetaben [18F] Injection is the first innovative PET tracer approved for marketing in China in nearly 20 years; its diverse pipeline, at various stages, broadly covers global innovative targets in radiopharmaceuticals, demonstrating the strong competitiveness of our pipeline and leading the new speed of innovative radiopharmaceutical development.
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