Haizheng pharmaceutical's class 3.1 new drug gefitinib API has been accepted

According to the website of the State Food and Drug Administration (CFDA), the class 3.1 new drug gefitinib API declared by Haizheng pharmaceutical 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 an anti-tumor targeting small molecule drug developed by AstraZeneca company in the UK Its preparation gefitinib tablet was first listed in Japan in 2002 and approved by the US FDA in 2003 It has become a three-line single drug for the treatment of locally advanced or metastatic non-small cell lung cancer It entered the Chinese market in 2005 According to CFDA data, at present, there are no domestic enterprises with the production approval of gefitinib API, but there are nearly 10 enterprises applying for the product In addition to Haizheng pharmaceutical, there are Kelun pharmaceutical, Hengrui pharmaceutical, Zhengda Tianqing, Qilu pharmaceutical, etc.