历时10年 华东医药重磅肿瘤创新药获批上市

Core Insights - Huadong Medicine has received approval from the National Medical Products Administration (NMPA) for its innovative drug, Maleate Mevanertinib Tablets, marking a significant advancement in the oncology field [1][2] Group 1: Drug Development and Approval - The Maleate Mevanertinib Tablets are a new, potent, selective, and orally active irreversible EGFR/HER2 small molecule inhibitor with independent intellectual property rights [1] - The drug's approval is based on a Phase III clinical trial that met the predefined superiority criteria, comparing Maleate Mevanertinib with Gefitinib for first-line treatment of EGFR-sensitive advanced non-small cell lung cancer (NSCLC) [2] - Huadong Medicine has invested approximately 306 million RMB in the development of Maleate Mevanertinib Tablets as of September 30, 2025, focusing on rare EGFR mutations and advanced NSCLC treatment [2] Group 2: Market Context and Impact - Lung cancer is the most prevalent and deadly malignancy globally, with NSCLC accounting for about 85% of primary lung cancer cases; approximately 50% of lung adenocarcinoma patients in China have EGFR mutations [3] - The approval of Maleate Mevanertinib Tablets represents a crucial breakthrough in Huadong Medicine's innovative layout in cancer treatment, providing a new option for patients with EGFR-mutated NSCLC [3]