Recently, the National Medical Products Administration (NMPA) has approved
the marketing of Pyrotinib Maleate Tablets (trade name: Aini), a Class 1
innovative drug independently developed by Hengrui Medicine for the treatment of
recurrent or metastatic breast cancer.
Supported by the National Major Science and Technology Special Project for "Major New Drug Development", Pyrotinib Maleate Tablets have obtained marketing approval through the priority review and approval procedure.
Pyrotinib maleate is an irreversible dual-targeted tyrosine kinase inhibitor (TKI) targeting human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR). Its mechanism of action is to covalently bind to the adenosine triphosphate (ATP)-binding sites within the intracellular kinase domains of HER2 and EGFR. This binding prevents the formation of homo- and hetero-dimers of HER2 and EGFR in tumor cells, inhibits their autophosphorylation, blocks the activation of downstream signaling pathways, and thereby suppresses tumor cell proliferation. The drug exerts simultaneous inhibitory effects on both EGFR and HER2, with a more durable action profile.
Breast cancer is one of the malignant tumors with high incidence rate among female cancers worldwide. The HER2 molecule is an independent prognostic factor for poor outcomes in breast cancer. Prior to the advent of targeted therapies against HER2, the overall survival of HER2-positive patients was only half that of HER2-negative patients. Pyrotinib Maleate Tablets provide a novel therapeutic option for patients with recurrent or metastatic breast cancer.
