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杭州再获批一款创新药
Mei Ri Shang Bao· 2025-10-27 22:22
Core Insights - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has successfully obtained the drug registration certificate for the innovative drug, Maleate Mevanertinib Tablets, marking its official market approval [1] - This approval represents the second innovative drug acquired by Zhongmei Huadong in a short period, following the approval of Remabipine Injection on October 17 [1] - The company has significantly increased its R&D investment, with a total of 1.484 billion yuan in the first half of the year, reflecting a year-on-year growth of 33.75% [1] Group 1 - The newly approved Maleate Mevanertinib Tablets are a novel, potent, and highly selective irreversible EGFR/HER2 small molecule inhibitor for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) [1] - The direct R&D expenditure reached 1.174 billion yuan, showing a year-on-year increase of 54.21%, and accounted for 15.97% of the pharmaceutical industrial revenue [1] Group 2 - The Hangzhou Market Supervision Administration has played a crucial role in facilitating the development of innovative drugs by establishing a regular communication mechanism with Zhongmei Huadong from the early stages of drug development [2] - The administration has implemented a "three commitments" approach to optimize the drug registration process, significantly shortening the approval timeline for the new drug [2]