DA accepts marketing application for innovative nuclear drug from Sinotau Pharmaceutical Group partner Lantheus
Sinotau Pharmaceutical Group partner Lantheus (NASDAQ: LNTH) recently announced that its new drug application (NDA) for its research product MK-6240 (also known as XTR006) has been officially accepted by the U.S. Food and Drug Administration (FDA). XTR006/MK-6240 is a potentially best-in-class new radiopharmaceutical targeting tau labeled with 18F for the auxiliary diagnosis of Alzheimer's disease (AD)-derived mild cognitive impairment or AD dementia. XTR006/MK-6240 has previously received Fast Track designation from the FDA because it is expected to meet the medical needs in the field of AD diagnosis. It is reported that the PDUFA date is August 13, 2026.
Data from two key Phase III clinical trials provide effective support for this NDA. The two studies were designed to evaluate the effectiveness of XTR006/MK-6240 in detecting tau pathology in early Alzheimer's disease and successfully met the co-primary endpoints of sensitivity and specificity.
Sinotau Pharmaceutical Group has obtained the exclusive development, production and commercialization rights of XTR006/MK-6240 in China in 2017, and is currently conducting phase III clinical research in China.
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About Sinotau Pharmaceutical Group
Sinotau Pharmaceutical Group ("Sinotau Pharmaceutical Group" for short), founded in 2005, is the leader in China's radiopharmaceutical market, with end-to-end capabilities across the entire industry value chain from radionuclide development and production to radiopharmaceutical R&D, manufacturing and commercialization. Sinotau Pharmaceutical Group adheres to the mission of "making good nuclear medicines and benefiting the public", is based in China, and looks at the world. The company is headquartered in Beijing, has a R&D center in Shanghai, and has built modern radiopharmaceutical production bases in Jiangsu, Guangdong, and Sichuan; at the same time, it has branches in the United States. Guided by unmet clinical needs, Sinotau Pharmaceutical Group focuses on the three major fields of neurodegenerative diseases, cardiovascular diseases, and oncology, and has established a comprehensive, differentiated and synergistic product matrix, which has great potential in the integration of radioactive diagnosis and treatment. Among them, Ouweining® is the first innovative PET tracer approved for marketing in China in the past 20 years; multiple product pipelines at different stages widely cover global innovative radiopharmaceutical targets, demonstrating the strong competitiveness of our pipeline and leading the new speed of the development of innovative radiopharmaceuticals.