Baiyunshan 3.1 new drug gefitinib API accepted
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Last Update: 2020-04-03
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Source: Internet
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Author: User
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According to the website of the State Food and Drug Administration (CFDA) on August 4, the class 3.1 new drug gefitinib API declared by Baiyunshan was accepted At present, only the original research drug is on sale in China, and there is no domestic enterprise producing gefitinib and related preparations Gefitinib is a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor It is the only effective drug for cancer caused by EGFR receptor mutation and overreaction It is an anti-tumor targeting small molecule drug, which is used to treat breast cancer, lung cancer and other cancers Gefitinib is developed by AstraZeneca company of the United Kingdom Its preparation gefitinib tablet was first listed in Japan in 2002 and approved by FDA of the United States in 2003 It has become a three-line single drug treatment drug for the treatment of locally advanced or metastatic non-small cell lung cancer It entered the Chinese market in 2005 and its domestic price is about 500 yuan / tablet According to CFDA data, at present, there are no domestic enterprises with production approval documents of gefitinib API, but nearly 10 enterprises have applied for the API In addition to Baiyunshan, there are Haizheng Pharmaceutical (600267 SH), Kelun Pharmaceutical (002422 SZ), Hengrui Pharmaceutical (600276 SH), Zhengda Tianqing, Qilu pharmaceutical, etc.
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