Gelonghui, East China Medicine (000963) (000963)NodepositbingofreemoneySZ) announced that on May 11, 2024, Hangzhou Sino-American East China Pharmaceutical Co., Ltd. (hereinafter referred to as "China-US East China"), a wholly owned subsidiary of the company, received the "acceptance notice" (acceptance number) issued by the State Drug Administration (NMPA).NodepositbingofreemoneyCXHS2400040, CXHS2400041), the application for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with epidermal growth factor receptor (EGFR) exon 21 L858R replacement mutation was accepted.
Maihuatinib tablet is a new type of irreversible EGFR/ human epidermal growth factor receptor-2 (HER2) small molecule inhibitor with strong potency, high selectivity and oral activity. It is a new national class 1 innovative drug with independent intellectual property rights. By covalently binding to the kinase regions of EGFR (ErbB1) and HER2 (ErbB2), mahuatinib irreversibly inhibits the autophosphorylation of tyrosine kinases, resulting in down-regulation of ErbB signal, thus inhibiting tumor growth.