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    Home > Medical News > Latest Medical News > Weigh! Junshi independent research and development, the first domestic PD-1 monoclonal antibody officially approved!

    Weigh! Junshi independent research and development, the first domestic PD-1 monoclonal antibody officially approved!

    • Last Update: 2018-12-17
    • Source: Internet
    • Author: User
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    On December 17, the State Drug Administration had the conditions to approve the first domestic PD-1 monoclonal antibody - treprizumab injection (trade name: tuoyi) This is an innovative biological product drug independently researched and developed by Chinese enterprises with full independent intellectual property rights, which is used to treat local progress or metastatic melanoma after the failure of previous standard treatment At present, the research focus in the field of tumor immunotherapy is mainly focused on the immunosuppressant such as anti programmed death-1 (PD-1) receptor, which is different from the traditional chemotherapy and targeted therapy, mainly through overcoming the immunosuppression in patients and reactivating their own immune cells to kill tumors It is a new anti-tumor treatment concept The approved trepril mAb is an all human monoclonal antibody against PD-1 receptor developed by Suzhou Zhonghe biomedical Co., Ltd It can block the binding of PD-1 of T-lymphocytes with PD-L1 on the surface of tumor cells, release the immunosuppression of tumor cells on immune cells, and enable immune cells to play the anti-tumor immune role again to kill tumor cells 。 Melanoma has been increasing rapidly in China in recent years It is one of the fastest growing malignant tumors The incidence rate of new cases is about 20000 each year The mortality rate is increasing rapidly year by year It has become one of the diseases that seriously endanger the health of our people In terms of treatment, there is a lack of effective standard treatment for melanoma patients who fail in the first-line treatment The clinical trial results showed that the objective remission rate, disease control rate and 1-year survival rate of patients with unresectable or metastatic melanoma who had previously failed to receive systemic therapy were 17.3%, 57.5% and 69.3%, respectively The approval of this product on the market is of positive significance to the choice of clinical medication for cancer patients in China As the first domestic monoclonal antibody with PD-1 as the target drug approved for marketing in China, trepril mAb has been supported by major national science and technology projects Since the beginning of 2016, clinical research and development of this product has been started, and so far, more than 20 clinical trials are in progress, including those in the United States In March 2018, the State Drug Administration officially accepted the listing registration application 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, the China food and Drug Control Institute and other relevant units work together to actively communicate and guide with the applicant, timely solve the technical problems encountered in the review, give priority to technical review, on-site inspection and laboratory inspection, and based on the validity data of the applicant's completed phase II study of advanced melanoma in China and 7 temporary items According to the safety data of the bed study, the product was approved for listing on December 17.
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