echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > Weigh! First domestic car-t declared for listing

    Weigh! First domestic car-t declared for listing

    • Last Update: 2020-04-16
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    On February 24, Fosun Pharmaceutical released the enterprise announcement, saying that recently, Fosun Kat Biotechnology Co., Ltd., a joint venture invested by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (received the acceptance notice (acceptance No.: cxss2000006 country), and its yiqilensai injection (proposed) (i.e., anti-human CD19 car-t cell injection) was used for adult relapsed refractory big B The treatment of cell lymphoma (including non-specific type of diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (pmbcl), advanced B-cell lymphoma and follicular lymphoma transformed DLBCL) has been accepted by the drug registration review of the State Drug Administration According to the announcement, anti human CD19 car-t cell injection is kit Pharma, Inc (hereinafter referred to as "kit Pharma", which is Gilead sciences, Anti human cd19car-t cell injection (trade name: yescarta) of Inc is mainly used for the treatment of relapsed refractory adult large B-cell lymphoma (including non-specific type of diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (pmbcl), advanced B-cell lymphoma and DLBCL transformed from follicular lymphoma) In October 2017, yescarta was approved by the U.S FDA (i.e the U.S Food and Drug Administration) for listing in the United States It is the first car-t cell drug approved by the U.S FDA for specific non Hodgkin's lymphoma In August 2018, yescarta was approved by European EMA (European Drug Administration) for listing in Europe Anti human CD19 car-t cell injection was introduced by Fosun Kate from kitepharma, and obtained the technical and commercial rights in mainland China, Hong Kong SAR and Macao SAR It is planned to be localized in China (excluding Hong Kong, Macao and Taiwan, the same below) In August 2018, the product was approved by the State Food and Drug Administration for clinical trials As of the announcement date, the product has completed the bridging clinical trial in China for the treatment of adult relapsed refractory large B-cell lymphoma In addition, according to the announcement, there is no similar drug with the same target in China approved for marketing Another car-t cell immunotherapy product approved for marketing worldwide is Novartis Pharma Schweiz AG Kymriah, whose target is CD19, is mainly used to treat children and young adults (2-25 years old) with acute lymphoblastic leukemia and adult relapse / refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma) According to the published financial reports of Gilead Sciences, Inc and Novartis Pharma Schweiz AG, the global sales of yescarta and kymriah in 2019 are about $456 million and $278 million respectively As of January 2020, Fosun Kate has invested about 474 million yuan in research and development of the product (including patent and technology license fees, without audit) 37
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.