Recently, according to Shanghai Hengrui Pharmaceutical Co., LTD., a subsidiary of Henrui Pharmaceutical, the anti-A β monoclonal antibody SHR-1707 injection for the treatment of early Alzheimer'sdisease (AD) completed the first patient enrollment and administration in the First Affiliated Hospital of the University of Science and Technology of China.
This clinical study (CTR20223438) is designed to evaluate the safety and tolerability of SHR-1707 in AD-derived mild cognitive dysfunction (mildcognitionimpairment, MCI) and mild AD patients and to initially explore the ability to brain clearance of β -amyloid (Amyloidbeta, A β). The study was led by the First Affiliated Hospital of USTC of China with 11 centers.
In 2022, SHR-1707 has completed a single dose clinical study of climbing in healthy people in China and Australia. These two phase I studies showed good safety and tolerability of a single dose of SHR-1707 ranging from 2mg / kg to 60 mg / kg in Chinese and Australians. After these two clinical studies, Hengrui Pharmaceutical launched the study of AD patients.
This study by the first hospital affiliated to China university of science and technology professor ShiJiong, he said: " according to incomplete statistics, at present our country has nearly ten million Alzheimer's disease patients, but for the disease in China is symptomatic treatment, no cause treatment, currently only in the United States approved two anti amyloid antibody treatment, so there is a lot of unmet clinical needs. Henrui team developed the first domestic fully independent development of the amyloid antibody, we are very happy with Henrui team design clinical trial scheme, through the project and ethical review, and the first subject, we will accelerate the 1707 research clinical trials, as soon as possible to bring more alzheimer's disease patients with new treatment options."
Dr. Jiang Ningjun, deputy general manager and chief strategy officer of Jiangsu Hengrui Pharmaceutical Co., Ltd., said, " SHR-1707 is A monoclonal antibody targeting A β, which slows down the cognitive decline of patients by reducing the level of A β in the brain. No such target drug has been approved in China. Based on our previous non-clinical data and the results of clinical research, Hengrui Pharma quickly launched the study, hoping to see the safety and preliminary effectiveness effects in this study, so as to push the drug to phase III study more quickly and bring this innovative drug to the vast number of patients in China."
SHR-1707 injection is by constant pharmaceutical subsidiary Shanghai pharmaceutical co., LTD., independent research and development of humanized anti-A β monoclonal antibody (IgG 1 subtype), can prevent A β plaque assembly or activate microglia swallow various forms of A β, thus reduce the A β level in AD patients with AD, delay cognitive function degradation and control the disease progression. In March 2021, SHR-1707 Injection obtained the Notice of Approval of Drug Clinical Trial issued by the State Food and Drug Administration, and agreed to carry out clinical research with the indication of AD.
