艾力斯:针对C797S突变NSCLC患者的治疗,公司有新一代的EGFR-TKI处于I期临床试验阶段

Core Viewpoint - The company,艾力斯 (688578.SH), emphasizes its commitment to innovation as a core competitive advantage and outlines its strategic focus on the development of its key product,伏美替尼, along with other innovative drug candidates [2]. Group 1: Product Development - The company is conducting in-depth research on伏美替尼, exploring multiple application scenarios beyond the already approved indications for second-line and first-line treatments [2]. - Ongoing clinical registrations for伏美替尼 include auxiliary treatment for classic EGFR mutations, second-line and first-line treatments for 20 exon mutations, PACC mutation indications, brain metastasis indications, and auxiliary treatment for non-classic EGFR mutations [2]. - The NDA application for the second-line treatment of the 20 exon mutation has been accepted and prioritized for review, while the PACC mutation NSCLC first-line treatment indication is expected to be classified as a breakthrough therapy by December 2025 [2]. Group 2: New Product Introductions - In August 2024, the company introduced the KRAS G12C inhibitor,戈来雷塞, and the SHP2 inhibitor, taking full responsibility for their subsequent development [2]. - The second-line treatment indication for戈来雷塞 in NSCLC was officially approved in May 2025, and ongoing studies are being conducted for its use in pancreatic cancer and other solid tumors [2]. - Clinical trials are progressing smoothly for the combination of戈来雷塞 with the SHP2 inhibitor for first-line treatment of KRAS G12C mutation non-small cell lung cancer [2]. Group 3: Research and Development Enhancements - The company is advancing its new drug discovery platform, enhancing its capabilities in both large and small molecule research, and strengthening team development [2]. - Several innovative drugs are currently in the preclinical research stage, indicating a robust pipeline for future growth [2]. - The company is committed to promoting the internationalization of its products, aiming to make innovative drugs accessible to patients worldwide [2].