State Drug Administration conditionally approves first domestic PD-1 single anti-"Trepri mono-anti-injection" market

today, the StateMedicines(http://Regulatory Authority has conditions to approve the first domestic PD-1 mono-resistance - Trepri mono-anti-injection (commodity name: Tuyi) listedthis is china'senterprises(http://independent research and development of biological products with fully independent intellectual property rightsnew drug(http://, used to treat previous standard treatment failure situating local progress or metastatic melanomaat present, the research focus in the field of tumor immunotherapy mainly focuses on immuno-checkpoint inhibitors such as anti-programmed death-1 (PD-1) receptors, which is different from traditional chemotherapy and targeted therapy, mainly by overcoming the immune suppression of the patient's body, reactivating the patient's own immune cells to kill the tumor, is a new anti-tumor therapy conceptthis approved Treplymono is an all-human monoclonal antibody anti-PD-1 receptor developed by Suzhou United Bio
Pharmaceutical(http://LimitedCompany (http:// , which can be developed by closing The PD-1 of T lymphocytes, blocking its binding to the surface pD-L1 of tumor cells, relieve tumor cells from the suppression of anti-tumor cells, and re-play the immune cell immune cells Triprei monoresist as China's first approved listing of the first domestic PD-1 as the target of the single anti-
drug (http:// , access to the national science and technology major special project support Since the beginning of clinical development in early 2016, more than 20 clinical trials have been (http:// , including simultaneous clinical trials in the United States March 1018, the State Drug Administration formally accepted the application for listing registration of this product, and included it in the priority review and approval varieties to speed up the review and approval The National Drug Review Center, the Drug Review and Inspection Center and the China Food and Drug Inspection Research Institute and other relevant units worked together to actively communicate and guide the reporting units, promptly resolve the technical problems encountered in the review, prioritize technical review, on-site inspection and laboratory testing, and on December 17, conditional approval of the product's registration based on the data on the validity of the chinese late melanoma PHASE II study and the safety data of 7 clinical studies