瞄准EGFR/HER2-TKI 创新药迈瑞东获批上市

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its innovative drug, Maleate Mevanertinib Tablets (brand name: Mairuidong), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 21 (L858R) substitution mutations [1][2] Group 1 - Maleate Mevanertinib Tablets are a new, potent, highly selective, orally active irreversible EGFR/HER2 small molecule inhibitor, representing a novel national class 1 innovative drug with independent intellectual property rights [2] - The drug irreversibly inhibits tyrosine kinase autophosphorylation by covalently binding to the kinase regions of EGFR (ErbB1) and HER2 (ErbB2), leading to downregulation of ErbB signaling and suppression of tumor growth [2] Group 2 - Huadong Medicine aims to actively promote the commercialization of Mairuidong post-approval, providing better clinical benefits to patients and striving to make it accessible to a wider patient population [1] - Mairuidong is the second innovative drug launched by Huadong Medicine within a week, following the approval of Remabizine Injection, which is part of a combination product for renal function assessment [1]