Core Viewpoint - The announcement by the company regarding its core product, Furmonertinib (brand name "Aifusha"), being included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutations [1] Group 1 - Furmonertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and is a first-class new drug independently developed by the company, classified as a small molecule targeted therapy [1] - Clinical research results indicate that Furmonertinib shows broad efficacy against various EGFR mutations, with its first-line treatment indication and the 20 exon insertion mutation first and second-line treatment indications included in the NMPA's breakthrough therapy list [1] - The 20 exon insertion mutation first-line treatment indication has also received breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) [1] Group 2 - Currently, both first-line and second-line treatment indications for Furmonertinib have been included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) [1]
艾力斯:伏美替尼被纳入突破性治疗公示名单