Core Viewpoint - The company, Elysium (688578.SH), announced that its innovative drugs, Fumetinib and Golecitinib, have been included in the National Medical Insurance Catalog for 2025, which is a significant milestone for the company and its product offerings [1]. Group 1: Drug Inclusion in National Insurance - Fumetinib and Golecitinib have been included in the National Medical Insurance Catalog, with Fumetinib continuing to be covered for first-line and second-line treatment indications after negotiations [1]. - Golecitinib has been included in the National Medical Insurance Catalog for the first time for its second-line treatment indication through negotiation [1]. Group 2: Clinical Efficacy and Safety of Fumetinib - Fumetinib is an EGFR-TKI developed by the company, showing broad efficacy against various EGFR mutations, with a confirmed objective response rate (ORR) of 44.3% and a median progression-free survival (PFS) of 8.3 months in clinical studies [2]. - The median overall survival (OS) observed so far for Fumetinib is 21.2 months, indicating its potential as a leading treatment option for patients with EGFR 20 exon insertion mutation [2]. - Fumetinib has demonstrated good tolerability at a dosage of 240mg QD, with no new or unexpected safety signals reported [2]. Group 3: Guidelines and Recommendations - Fumetinib has been included in several authoritative domestic guidelines, such as the CSCO Non-Small Cell Lung Cancer Guidelines (2025 edition) and the Clinical Diagnosis and Treatment Guidelines for Gene-Positive Non-Small Cell Lung Cancer Brain Metastasis (2025 edition) [3]. - The first professional consensus document focusing on EGFR PACC mutation NSCLC recommends considering Fumetinib as a first-line treatment option for patients with advanced NSCLC based on current evidence [3].
艾力斯:公司创新药品纳入新版国家医保目录