迪哲医药舒沃哲在美获加速批准上市 系该靶点全球首款药物

Core Viewpoint - Dize Pharmaceutical's drug, Shuwotini (generic name: Shuwotini tablets), has received FDA approval for its New Drug Application (NDA), marking it as the first and only EGFR exon20ins NSCLC drug approved by the FDA globally [1][2]. Group 1: Drug Approval and Significance - Shuwotini is approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression after platinum-based chemotherapy and have confirmed EGFR exon20ins mutations [1]. - The drug was granted priority review and is recognized as a breakthrough in treating a challenging target that has seen limited treatment options for nearly 20 years [1][3]. - Shuwotini is an oral, irreversible, and highly selective EGFR tyrosine kinase inhibitor (TKI) that targets multiple EGFR mutation subtypes [1]. Group 2: Clinical Research and Efficacy - The FDA approval is based on the efficacy and safety data from the international multicenter clinical study "WU-KONG1B," which will be presented at the 2024 ASCO annual meeting and has been accepted for publication in a top-tier journal [2]. - The study demonstrated significant efficacy advantages of Shuwotini, validated in both Asian and non-Asian patient populations, enhancing treatment convenience and patient compliance with its once-daily oral administration [2]. Group 3: Market Impact and Stock Performance - Following the announcement of FDA approval, Dize Pharmaceutical's stock price rose by 9.54%, reaching 64.56 yuan per share [4].