Congruity evaluation of capecitabine tablets

According to yaozhi.com, Hengrui pharmaceutical recently received the approval document for supplementary drug application approved and issued by the State Drug Administration, which approved the company capecitabine tablets to pass the quality and efficacy consistency evaluation of generic drugs Capecitabine is a precursor of 5- fluorouracil, which can be transformed into 5- fluorouracil by high concentration of thymidine phosphorylase (TP) in tumor tissue, inhibit the synthesis of DNA and RNA, and play an anti-tumor role Capecitabine is widely used in single or combined clinical treatment of breast cancer, rectal cancer, colon cancer, liver cancer, gastric cancer, esophageal cancer, cervical cancer, pancreatic cancer and other cancers, It has the advantages of no cytotoxicity, good curative effect, high safety and convenient oral administration Hengrui pharmaceutical capecitabine tablets were approved for listing in December 2013, and the application for conformity evaluation of 0.5g generic drugs of capecitabine tablets submitted in January 2019 was accepted 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, capecitabine tablets have been approved to be listed in EU, Japan and other places; in March 2001, capecitabine tablets of Roche company were approved to be listed by CFDA, with the commodity name of Xeloda ® The 0.5g specification of capecitabine tablets of the company was approved and passed the consistency evaluation of generic drugs In addition, 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 According to the query, capecitabine's total global sales in 2018 are about $770 million, and its domestic sales are about $267 million Up to now, Hengrui pharmaceutical has invested about 17.91 million yuan in research and development of this product project According to pharmaceutical intelligence data, up to now, Hengrui pharmaceutical has 6 products passed the consistency evaluation, 7 products are deemed to have passed the consistency evaluation, and 27 products have been applied for approval 37