The General Administration approved the listing of three domestic generic drugs, including gefitinib tablets.


Release time:

2017-01-13

Recently, the State Food and Drug Administration approved the listing of domestic generic drugs of the anticancer drug gefitinib tablets, the anti-AIDS drug efavirenz tablets and tenofovir disoproxil fumarate tablets.
Gefitinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that inhibits tumor growth, metastasis, and angiogenesis by selectively blocking the epidermal growth factor receptor signaling pathway. Eferavirenz is a selective non-nucleoside reverse transcriptase inhibitor of human immunodeficiency virus type 1 (HIV-1), with high oral bioavailability and long half-life. It is clinically used for HIV-1 infection in adults, adolescents and children over 3 years old. Tenofovir disoproxil fumarate is a nucleotide reverse transcriptase inhibitor (NtRTI) that can be used in combination with other antiretroviral drugs to treat HIV 1 infection. The above products are first-line commonly used therapeutic drugs in related therapeutic areas.
Gefitinib tablets produced by Qilu Pharmaceutical (Hainan) Co., Ltd., efavirenz tablets produced by Shanghai Diseno Biopharmaceutical Co., Ltd. and tenofovir disoproxil fumarate tablets produced by Chengdu Beite Pharmaceutical Co., Ltd. approved by the General Administration are the first drugs to be successfully imitated in China, which are basically consistent with the quality and efficacy of the original drugs. At the same time, the General Administration approved the listing of the corresponding domestic raw materials, and realized the localization from raw materials to preparations.
Since the beginning of 2016, the General Administration has implemented priority review and approval for innovative drugs for the prevention and treatment of AIDS, malignant tumors, major infectious diseases and rare diseases, as well as clinically urgently needed drugs. By the end of December 2016, 12 batches of priority drug review and approval catalogues had been published, involving 191 registration applications. In the follow-up, the General Administration will continue to increase its support for the application of drugs with obvious clinical value for the treatment of AIDS and other major diseases, encourage drug innovation, improve drug quality, and improve the safety and accessibility of drug use for the majority of patients.