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    Home > Medical News > Medical Research Articles > Production approval of tegio tablet, a class 3.2 new antitumor drug of Fuyao pharmaceutical

    Production approval of tegio tablet, a class 3.2 new antitumor drug of Fuyao pharmaceutical

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    On February 24, the new anti-tumor drug (chemical 3.2) tegio tablet developed by Fuzhou haiwangfu Pharmaceutical Co., Ltd received the new drug certificate and drug production approval issued by the State Administration With the active help of the drug registration office of Fujian Provincial Bureau, Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd and Shenzhen Haiwang Pharmaceutical Co., Ltd started to jointly research and develop tegio API and tegio tablet preparations since 2005, completed the clinical research application and production in 2010, passed the pre listing inspection of the State Administration in 2013, and finally obtained the production approval from the State Administration in February 2014, It lasted nearly 10 years At present, only three companies in the country have successively obtained the production approval of tegio capsule, while tegio tablet is the exclusive product of Fuzhou haiwangfu Pharmaceutical Co., Ltd Tegeor tablet is a compound preparation containing tegafur, gemcitabine and otilacy potassium Its main indications are unresectable local advanced or metastatic gastric cancer, which can inhibit and improve the toxic and side effects of tegafur According to some data, more than 80% of patients with advanced gastric cancer in Japan use tegio Domestic tegio capsule has been in rapid volume since it was launched in 2009, with a compound growth rate of 124% in 2010-2012 In 2012, the domestic sales volume is about 446 million yuan, and the terminal scale is expected to be close to 1.4 billion yuan, ranking among the top ten anti-tumor drugs in China The successful listing of the drug will become a new economic growth point of Fuzhou Haiwang Pharmaceutical Co., Ltd., and also add a "heavy" variety of anti-tumor clinical drugs in Fujian Province Tegio capsule was developed and produced by Japan Dapeng Pharmaceutical Co., Ltd in 1999 Its trade name is "ESWAN" It is a fluorouracil derivative oral anti-tumor drug In 2009, ESWAN was officially listed in China as an indication of advanced gastric cancer At present, it is mainly used in the treatment of gastric cancer and colorectal cancer Compared with the original imported drugs, the domestic generic drugs are more widely used For example, adjuvant chemotherapy for gastric cancer and colorectal cancer after operation It can also be used alone or in combination with other drugs for the treatment of advanced gastric cancer and colorectal cancer In addition, tegio is a broad-spectrum anti-tumor drug, the indications are also expanding, and it may be used in the treatment of other cancers in the future For example, the indication of tegio for lung cancer in China has entered the clinical trial stage Although Aswan has been approved by Japan for the treatment of advanced gastric cancer, head and neck cancer, rectal cancer, non-small cell lung cancer, metastatic breast cancer, pancreatic cancer and cholangiocarcinoma and other seven tumor diseases, Yang Jianwei reminded that the same anti-tumor drug has different indications in different countries, and tumor patients should not use it blindly For example, according to the evidence-based medicine evidence of various countries, tegio's indications for colorectal cancer are not well recognized in Western European countries, but have been recognized in China, Japan, South Korea and other East Asian countries  
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