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    Home > Active Ingredient News > Drugs Articles > Nanjing legend car-t cell therapy clinical approval

    Nanjing legend car-t cell therapy clinical approval

    • Last Update: 2018-03-14
    • Source: Internet
    • Author: User
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    Source: biological products circle March 12, 2018 at 10 a.m., the State Food and Drug Administration approved the application project of Nanjing legend Biotechnology Co., Ltd (a wholly-owned subsidiary of Kingsley), the clinical trial application of lcar-b38mcar-t cell autotransfusion preparation (referred to as lcar-b38m cell preparation), which is currently waiting for the certification process Lcar-b38m is a car-t therapy targeting BCMA developed by Nanjing legend According to the data, in a clinical trial involving 35 patients with recurrent or drug-resistant multiple myeloma, the objective remission rate of the treatment reached 100% Among the 19 patients who received the first treatment, Nanjing Chuanqi followed up for more than 4-14 months Among them, 14 patients continued to meet the strict diagnostic criteria of complete response, and 5 patients showed partial remission On December 8 last year, Kingsley took the lead in declaring clinical trials of car-t cell therapy in China, but the approval has been repeated In January, the center for drug review of the State Food and Drug Administration completed three technical reviews of its pharmacology, toxicology, clinical and pharmacy However, in February, all procedures were reversed and returned to the status to be reviewed In early March, the review was completed again The reason for this is the request for additional materials from Kingsy This shows that the State Food and drug administration is cautious in the review, and also shows that Kingsley's application quality is good At present, the State Food and drug administration has accepted about 13 clinical applications for car-t cell therapy, and relevant companies of listed companies such as Anke biology and Hengrun Dashen have applied However, in terms of the approval process, except for Kingsley completing the technical review, other companies have not yet started or are in the process of review Fosun pharma and kit Pharma jointly established Fosun Kate in China, so as to obtain the commercial rights of kit's car-t therapy kte-c19 in China and the priority authorization of subsequent products Anke biology is about to start clinical trials of car-t therapy for leukemia treatment Car-t technology level is at the same time with that of the United States It is in the leading position in China The company has laid out cell production lines that meet GMP standards and actively prepares for the application of car-t cell treatment products It is expected to become the first car-t cell treatment enterprise in China that has the clinical conditions for application Once approved, the price of car-t therapy in China will be greatly reduced compared with the treatment fee of more than 400000 US dollars in foreign countries Keji biology, a subsidiary of zoli pharmaceutical, is actively promoting the upgrading and new clinical application of car-t technology, striving to become the first batch of enterprises applying for clinical research to SFDA Two of the follow-up patients had a survival period of more than 27 months Up to now, two car-t products have been approved for marketing in the world, namely kymriah (tisagenlecleucel) from Novartis and yescarta (kte-c19) from kite pharmaceutical The indications of the two are different Kymriah was approved for the treatment of acute lymphoblastic leukemia (all) in children and young adults (2-25 years old) at a price of $475000 Yescarta was approved for the treatment of certain types of large B-cell lymphoma at a price of $373000.
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