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On December 29th, ZhengDaTianQing submitted according to the new 4 categories of Malay acid afatini tablet generic drug market application was approved by the State Drug Administration, becoming the third domestic enterprise to be approved for listing of the product, after approval as if through a consistent evaluation.
Afatini belongs to the second generation of EGFR-TKI, developed by Grigg Ingham.
unlike the first generation of reversible EGFR TKI, afatinib irreversibly binds to EGFR to close the cell signaling path and inhibit tumor growth.
approved by the FDA in July 2013 and entered China in February 2017 for first-line/second-line treatment of non-small cell lung cancer positive for EGFR mutations.
is a category B of Health Insurance 2020.
EGFR gene mutation is the most common type of gene mutation in patients with non-small cell lung cancer in China, accounting for about 50%.
8 EGFR-TKIs have been approved for listing worldwide.
Hausen Pharmaceuticals and Qilu's Afatini have been approved for listing in China in June and September this year, respectively, the Pharmaceutical Rubik's Cube database PharmaGo shows that there are currently five domestic manufacturers according to the new 4 categories of Afadinie listing applications, including Shi Pharmaceutical Group, Yangzijiang, Colum Pharmaceuticals and so on.
addition, Zhengda Qingji non-tini tablets have been approved for listing in 2019.5, and passed the consistent evaluation.
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