mifanertinib

Mifanertinib (formerly known as mefatinib or MET-306) is an orally active, irreversible, small-molecule dual inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) tyrosine kinases. Developed by Suzhou Maitai Biotechnology and Huadong Medicine (Zhongmei Huadong), mifanertinib covalently binds to the kinase domains of EGFR and HER2, blocking autophosphorylation and downstream signaling pathways to inhibit tumor cell proliferation. In October 2025, mifanertinib maleate tablets (under the brand name MaiRuiDong) were approved by the China National Medical Products Administration (NMPA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 21 L858R substitution mutations. It has also received Breakthrough Therapy Designation in China for the treatment of advanced NSCLC with rare EGFR mutations (G719X, L861Q, and/or S768I).

Brand names

MaiRuiDong

Other names

maihuatinibmefatinibmefatinib maleatemelfatinibmifanertinib maleate