艾力斯(688578.SH)：甲磺酸伏美替尼片EGFRPACC突变NSCLC一线治疗适应症纳入拟突破性治疗品种公示

Core Viewpoint - The company艾力斯(688578.SH) has announced that its core product,甲磺酸伏美替尼片 (brand name "艾弗沙®", abbreviated as "伏美替尼"), has been 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 epidermal growth factor receptor (EGFR) PACC mutations [1] Group 1 - The proposed indication for 伏美替尼 is as a first-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR PACC mutations, with the public announcement period set from December 25, 2025, to January 4, 2026 [1] - 伏美替尼 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 伏美替尼 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] Group 2 - 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] - Currently, both first-line and second-line treatment indications for 伏美替尼 have been included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) [1]