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    Home > Active Ingredient News > Drugs Articles > Hengrui "capecitabine tablets" passed the consistency evaluation, and there were 13 varieties that had been evaluated

    Hengrui "capecitabine tablets" passed the consistency evaluation, and there were 13 varieties that had been evaluated

    • Last Update: 2020-02-18
    • Source: Internet
    • Author: User
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    On February 18, Hengrui released a notice that capecitabine tablets (0.5g) of the company passed the consistency evaluation of quality and efficacy of generic drugs Capecitabine is a precursor drug of 5-fluorouracil, which can be transformed into 5-fluorouracil by high concentration of thymidine phosphorylase (TP) in tumor tissue in vivo, inhibit the synthesis of DNA and RNA, and play an anti-tumor role Capecitabine tablets were developed by Roche company and first approved in the United States in April 1998 The commercial name is Xeloda ®, with specifications of 0.15g and 0.5g Capecitabine tablets are used to treat advanced primary or metastatic breast cancer that is ineffective in chemotherapy of anthracycline drugs such as paclitaxel and doxorubicin Subsequently, the FDA approved capecitabine for metastatic colorectal cancer and adjuvant treatment of colorectal cancer Up to now, the product has been approved for listing in many places such as the European Union and Japan; in March 2001, capecitabine tablet of Roche company was approved for listing by the original CFDA, with the commodity name of Xeloda ® According to the announcement, the 0.5g specification of capecitabine tablets of the company has been approved and passed the generic consistency evaluation, and the 0.15g specification of capecitabine tablets is under review In addition to Hengrui pharmaceutical, at present, only Qilu pharmaceutical has passed the generic drug consistency evaluation in China In addition, Zhengda Tianqing, Chengdu Yuandong and Nanjing Youke have applied for approval, but no approval information has been found Capecitabine's total global sales in 2018 are about $770 million, and its domestic sales are about $267 million Up to now, the R & D cost of the product project has been about 17.91 million yuan According to insight database, as of February 18, Hengrui had passed / deemed to have passed the consistency evaluation of 13 varieties.
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