maihuatinib

Maihuatinib (also known as mefatinib or MET-306) is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) that targets the epidermal growth factor receptor (EGFR). It is specifically designed to inhibit EGFR mutations, including the common exon 21 L858R substitution and rare mutations such as G719X, L861Q, and S768I, which are drivers in non-small cell lung cancer (NSCLC). Developed by Huadong Medicine (and RedCloud Bio under the code H002), maihuatinib has been evaluated in both first-line and pre-treated settings for locally advanced or metastatic NSCLC. As of mid-2025, a New Drug Application (NDA) for maihuatinib is under review in China for the treatment of patients with EGFR L858R mutation-positive NSCLC, supported by Phase III data comparing it to gefitinib.

Brand names

迈华替尼

Other names

mefatinibmayhertinib迈华替尼