华东医药一类新药迈瑞东获批 肿瘤管线再扩容

Core Viewpoint - Huadong Medicine's innovative drug, Mevanertinib (brand name: Mairuidong), has received approval from the National Medical Products Administration (NMPA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR exon 21 (L858R) substitution mutation [1][3]. Group 1: Product Details - Mevanertinib is a novel, potent, highly selective, orally active irreversible EGFR/HER2 small molecule inhibitor with independent intellectual property rights, representing a new category of Class 1 innovative drugs in China [1][3]. - The drug works by covalently binding to the kinase regions of EGFR (ErbB1) and HER2 (ErbB2), irreversibly inhibiting tyrosine kinase autophosphorylation, leading to downregulation of ErbB signaling and tumor growth suppression [1][3]. Group 2: Market Context - Lung cancer is the most prevalent and deadly malignancy globally, with China being one of the countries with the highest incidence rates. In 2024, lung cancer accounted for 1.0606 million new cases in China, making it the leading cause of cancer-related deaths [2]. - NSCLC represents approximately 85% of primary lung cancer cases, with around 50% of lung adenocarcinoma patients in China having EGFR mutations. The L858R substitution mutation accounts for 30%-40% of these mutations [2]. Group 3: Company Strategy and Future Plans - Huadong Medicine is preparing to actively promote the commercialization of Mevanertinib following its approval, indicating a strong commitment to addressing unmet clinical needs in the treatment of NSCLC [3][4]. - The company has established a robust pipeline of over 80 ongoing research projects, focusing on endocrine, autoimmune, and oncology therapeutic areas, and is particularly advancing in cutting-edge fields such as ADC and CAR-T [3][4]. - Huadong Medicine aims to continue developing innovative drugs that provide clinical advantages, guided by clinical value and patient-centered approaches [4].