Beijing, China —Beijing Sinotau International Pharmaceutical Technology Co. , Ltd. is pleased to announce that the innovative radiopharmaceutical XTR020 for prostate cancer diagnosis has recently completed the enrollment and dosing of all subjects in its Phase III clinical study in China, marking a significant milestone in the product’s research and development in China. Despite clear and urgent clinical demand, there are currently no approved PSMA-targeted PET tracers in China. We plan to complete the Phase III clinical study and submit a New Drug Application (NDA) in early 2026.
XTR020 (Posluma®, flotufolastat F 18) is an innovative 18F-labeled, PSMA-targeted PET tracer used for diagnosing primary and metastatic lesions of prostate cancer, assisting in disease staging, screening patients suitable for PSMA-targeted radioligand therapy, and evaluating treatment efficacy, among other clinical scenarios. XTR020 has completed two pivotal Phase III clinical studies in the United States, demonstrating favorable efficacy and safety profiles, and received approval from the U.S. FDA in May 2023.
Prostate cancer is one of the most common malignancies among men. Early and accurate diagnosis, particularly for identifying micro-metastases or recurrent lesions, is critical to clinical outcomes. Conventional imaging methods, such as CT or MRI, have limitations in detecting early or minimal lesions. PSMA is highly expressed in prostate cancer cells, making it an ideal molecular target for PET imaging. As an 18F-labeled radiopharmaceutical, XTR020 has a radioactive half-life of 109.7 minutes, which is longer than that of 68Ga-labeled agents (radioactive half-life: 67.7 minutes). This characteristic offers advantages in logistics and distribution, enabling broader regional coverage and more efficient clinical workflows, thereby strongly supporting its potential for widespread clinical use post-approval.
Note: flotufolastat F 18 (also known as XTR020) was initially developed by Blue Earth Diagnostics. We have obtained exclusive rights for the development, production, and commercialization of the product in mainland China. The product has completed two pivotal Phase III studies, LIGHTHOUSE and SPOTLIGHT, in the United States.
About Sinotau
Sinotau, founded in 2005, is a pioneer 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 the mission of “Invent Radiopharmaceuticals for Lives”, Sinotau is rooted in China with a global vision. Sinotau is headquartered in Beijing, with an early-stage discovery center in Shanghai, modern radiopharmaceutical production bases in Jiangsu, Guangdong, and Sichuan, and 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 our 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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