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APRINOIA Therapeutics announced today that China's State Drug Administration (NMPA) has approved the launch of Phase III clinical trials to evaluate APRINOIA's positive electron emission fault scanning (PET) imaging tracer 18F-APN-1607, which targets abnormal tau protein aggregations in the brains of patients with cognitive impairment.
18F-APN-1607 is a next-generation tau PET imaging tracer with improved selectivity and off-target binding spectrum.
it is designed to specifically identify tau proteins in pathological aggregation, but does not recognize normal tau proteins.
the purpose of this Phase III clinical trial is to assess the safety and effectiveness of 18F-APN-1607 in distinguishing between mild cognitive impairment (MCI) and alzheimer's disease (AD) at different stages.
the trial will recruit about 230 subjects, all of them 18F-APN-1607.
Tzu-Chen Yen, China director of APRANOIA, said: "We are pleased that 18F-APN-1607 is an important step towards commercialization.
diagnosis is the basis for an effective treatment plan for neurodegenerative diseases.
our goal is to provide 18F-APN-1607 access nationwide in the future for accurate diagnosis."