Gefitinib, a Class 3 antitumor drug of Peking University medicine, has been accepted

According to the website of the State Food and Drug Administration (CFDA) on April 15, gefitinib, a Class 3 antitumor drug, applied by Peking University Pharmaceutical Co., Ltd., was accepted At present, only the original tablets are 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 Peking University pharmaceutical, there are Haizheng pharmaceutical, Kelun pharmaceutical, Hengrui pharmaceutical, Zhengda Tianqing, Qilu pharmaceutical, etc Peking University Pharmaceutical is mainly engaged in chemical raw materials and preparations It has 12 categories, including sulfonamides, antibiotics, vitamins, antipyretics and analgesics, quinolones and anti infection, and more than 100 varieties of raw materials and preparations In October 2012, Peking University Pharmaceutical and founder Pharmaceutical Research Institute signed a strategic cooperation agreement In the next five years, the company invested 10 million yuan in total to cooperate on nine new drug projects in three fields, including mental diseases, gastrointestinal diseases and anti-tumor.