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my country approves the first PD -1 antibody drug listing anti -tumor drug registration application for priority approval
Release time: 2018-07-10 & nbsp & nbsp & nbsp Source: Anonymous

Recently,The State Drug Administration approves the import application for the import registration of Nawu Liyouzumab injection。This is the first monoclonal anti-anti-anti-antidote for PD-1 as the target for registration,It is positive for solving the availability of clinical medication in tumor patients stake online sports bettingin stake betting appmy country,It will also effectively promote the development of tumor immunotherapy in my country。

In the field of cancer treatment,Clinical regular treatment is surgical treatment、Chemotherapy、radiotherapy and targeted drug treatment。These treatments have a certain effect,But far from meeting the treatment needs。In recent years,Oncology immunotherapy can achieve "clinical cure" effect,The key area of ​​becoming the focus of cancer research。

Current,Research hotspots in the field of tumor immunotherapy are mainly concentrated on anti-procedure-oriented death -1 (PD-1) receptor and other immune examination point inhibitors,It is different from traditional chemotherapy and targeted therapy,Mainly re -activate the immune cells to kill tumors by overcoming the immunosuppressing in the patient,Is a new concept of anti -tumor treatment。

The approved Nawuli Ulitabeta injection is a full-person monoclonal antibody developed by the anti-PD-1 receptor developed and developed by Bellet,PD-1 can be closed by closed T lymphocytes,Block it combined with PD-L1 on the surface of tumor cells,Lift the immunosuppressive suppression of tumor cells My stake betting appto stake betting appimmune cells,Make immune cells re -play with anti -tumor cells immune to kill tumor cells。

Beltay Schimingbao Company first carried out and completed the drug after the treatment of platinum dual drug chemotherapy,Clinical trials of advanced non -small cell lung cancer patients with advanced diseases,and submit the application for import drug registration。The State Drug Administration will accelerate the completion of the technical review of this product in accordance with the priority review procedures,and clinical trial data on -site inspection,and approve the import registration of this product on June 15, 2018。

Lung cancer is a vicious tumor for high incidence in the world,The mortality rate ranks first in various malignant tumors。In recent years,Some targeted therapy drugs have achieved better effects in the field of lung cancer treatment,But for advanced non -small cell lung cancer for advanced non -driven gene mutations, chemotherapy is still mainly chemotherapy,Patient's total survival period is usually shorter。This product clinical trial data shows,Compared with the current second -line standard treatment,This product can extend the stake online sports bettingmedian stake betting apptotal survival of patients with advanced non -small cell lung cancer for about 3 months。

Current,US Food and Drug Administration (FDA) has approved multiple PD-1 antibody drugs,The scope of adaptation has also been expanded,Including melanoma、Non -small cell lung cancer、head and neck cancer、colorectal cancer, etc.。

Under the background of the review and approval reform of drug review,Anti -tumor drug registration application with obvious clinical advantages has been clearly included in the scope of priority review。In recent years,Domestic enterprises quickly deploy tumor immunotherapy drug research and development,PD-1 antibody drug research and development registration of many companies has entered the review stage。Shanghai Junshi Biomedical Technology Co., Ltd.、Xinda Biopharmaceutical (Suzhou) Co., Ltd.、Jiangsu Hengrui Pharmaceutical Co., Ltd.,It has been explicitly included in the scope of priority review of the Drug Review Center。According to the relevant personnel of the Drug Review Center,Time to "shorten" the review time of domestic PD-1 drugs,"It is expected to approve the listing within 4 to 6 months"。