Suzhou Xinxu Pharmaceutical tau protein PET tracer clinical phase III trial was approved and started

Suzhou Xinxu Pharmaceuticals announced on the 22nd, the company's tau protein positive electron emission fault scanning (PET) tracer 18F-APN-1607 clinical phase III trial plan, has been approved by the State Drug Administration. From now on, the company started clinical phase III trial preparation and implementation work.Zhang Mingkui, Chairman of Suzhou Xinxu Pharmaceuticals, said, "We are pleased to announce the official launch of the clinical phase III trial of Xinxu's tau protein PET tracer 18F-APN-1607, marking a further step forward in Xinxu Pharmaceutical's goal of making neurodegenerative diseases, including Alzheimer's disease, more accurately diagnosed at an early date with non-invasive, targeted bio-target tracers." " Internationally renowned nuclear medicine experts, Suzhou Xinxu Pharmaceutical General Manager, Dr. Yu Zixuan said, "Neuromedicine using positive electron emission fault scanning to form stereoscopic images to accurately identify diseases, master the disease process of the technology gradually matured and popularized, tau protein tracer into the clinical phase III trial will help to achieve early diagnosis of dementia, for patients to develop an integrated medical program, monitoring the therapeutic effect of the vision." The18F-APN-1607 tracer accurately quantifies abnormal tau protein build-up in the brain. In addition to distinguishing between normal and dementia patients, it is also possible to judge the severity of Alzheimer's disease patients and achieve the goal of early and accurate diagnosis and prediction of the progression of the disease.The 18F-APN-1607 tracer is a small molecular drug designed to target the mutant tau protein and is highly specialized. After injection of 18F-APN-1607 tracer, the patient was scanned by PET and was able to reveal the location and quantity of the mutated tau protein in the brain, except for 3 repeats (3R) tau and 4 repeats (4 repeats) of Alzheimer's disease. In addition to 4R) tau protein deposition, neurodegenerative diseases such as pertinary nuclear paralysis (PSP), cortical substrate throbination (CBS), frontal temporal lobe dementia (FTD) and so on can also be identified.The main goal of this clinical phase III trial of Suzhou Xinxu Pharmaceutical is to understand the subject's intake pattern of 18F-APN-1607 tracer, and to measure the standardized ingestion ratio (SUVR) of 18F-APN-1607 in the overall area of interest (iROI), which reflects the deposition of tau protein aggregates. The secondary objective is the evaluation of the safety and tolerance of the drug.The Clinical Phase III trial will be conducted at several key neuroclinical centers in China and will include 230 subjects, including clinically diagnosed Alzheimer's disease (AD) patients and patients with mild cognitive impairment (MCI), compared with healthy elderly volunteers.Alzheimer's disease causes mental retardation and disability, which has not yet been effectively reversed by the medical community, and the huge cost of care for families, communities and governments caused by patients fighting the disease has become a major global public health issue. According to the 2019 Alzheimer's Research Report on the Family Survival of Alzheimer's Patients in China, published by the Alzheimer's Association of China in 2019111, China has become the world's largest country with Alzheimer's disease, with more than 10 million patients; In order to safeguard the health of the Chinese people and solve the current important health problems, last year the State Council issued the Health China Action (2019-2030) strategy, which clearly states that 2030 "the growth rate of dementia prevalence in china's 65-year-olds and above" According to the "2 indicator", Suzhou Xinxu Pharmaceutical's tau protein PET tracer is expected to help the early diagnosis of neurodegenerative diseases including Alzheimer's disease, interventional progression, to maintain the quality of life and dignity of patients and care for the family.About Suzhou Xinxu PharmaceuticalsSuzhou Xinxu Pharmaceuticals is based in Suzhou, a subsidiary of Xinxu Sheng Technology Co., Ltd., focusing on the Chinese market, commercializing the new positive electron emission fault scanning (PET) image diagnostic tracer. The company is committed to standardizing drug manufacturing, clinical execution, data analysis and other industries industry chain, to create an international level of PET image platform. Xinxu Pharmaceuticals is currently working with scientific research and industry partners to reduce the burden of mental illness on patients, families and society in order to gradually implement the vision of a healthy China.About Xinxusheng TechnologyWas established in 2015, Xinxusheng Technology Co., Ltd. focuses on the field of neurodegenerative diseases, has a leading drug screening platform and technology, the development of large and small molecule therapeutic drugs and related imaging diagnostic tracer. Asahi Technology brings together medical research professionals from around the world to set up operating subsidiaries and strongholds in Taipei, Suzhou, Shanghai, Tokyo, and Boston to work together to achieve accurate brain diagnosis and treatment. (Biological Exploration):2019 Research Report on the Family Survival of Alzheimer's Patients in China