Gelonghui, May 12, 丨 Huadong Pharmaceutical (000963.SZ) announced that on May 11, 2024, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “China-US Huadong”), a wholly-owned subsidiary of the company, received the “Notice of Acceptance” (acceptance numbers: CXHS2400040, CXHS2400041) issued by the National Drug Administration (NMPA), and Meifertinib tablets (Mifertinib Tablets) were declared as the applicant by China and US Huadong as the applicant The marketing license application for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with exon L858R replacement mutation was accepted.
Mehuatinib tablets are a novel, potent, highly selective, and orally active, irreversible EGFR/human epidermal growth factor receptor-2 (HER2) small molecule inhibitor. It is a brand new class 1 innovative drug with independent intellectual property rights in the country. Mehuatinib irreversibly inhibits tyrosine kinase autophosphorylation through regional covalent binding with EGFR (ErbB1) and HER2 (ErbB2) kinase regions, leading to a reduction in ErbB signaling, thereby inhibiting tumor growth.