艾力斯(688578.SH)发布公告，公司创新药品甲磺酸伏美替尼片(商品名"艾弗沙"，以下简称"伏美替尼") 和枸橼酸戈来雷塞片(商品名"艾瑞凯"，以下简称"戈来雷塞")均被纳入《国家基本医疗保险、生育保险 和工伤保险药品目录(2025年)》(以下简称"国家医保目录")。其中，伏美替尼一线及二线治疗适应症经 医保谈判后继续纳入国家医保目录;戈来雷塞二线治疗适应症通过医保谈判方式首次被纳入国家医保目 录。 ...

其中，伏美替尼一线及二线治疗适应症经医保谈判后继续纳入国家医保目录；戈来雷塞二线治疗适应症 通过医保谈判方式首次被纳入国家医保目录。 北京商报讯（记者 丁宁）12月7日晚间，艾力斯（688578）发布公告称，公司创新药品甲磺酸伏美替尼 片（商品名"艾弗沙"，以下简称"伏美替尼"）和枸橼酸戈来雷塞片（商品名"艾瑞凯"，以下简称"戈来 雷塞"）均被纳入《国家基本医疗保险、生育保险和工伤保险药品目录（2025 年）》（以下简称"国家 医保目录"）。 ...

Core Viewpoint - The article discusses the approval of the KRAS G12C inhibitor, Goratirsen (brand name "Airikai"), by the National Medical Products Administration for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one systemic therapy [2][3]. Group 1: Product Approval and Financial Implications - The approval of Goratirsen triggers a milestone payment of 50 million yuan to the developer, Gako Pharmaceutical, from its partner, Ailis [3]. - Lung cancer is the most prevalent and deadly malignancy globally, with non-small cell lung cancer accounting for approximately 85% of all lung cancer cases [3]. Group 2: Clinical Study Results - The approval is based on a pivotal Phase II single-arm study assessing the safety, tolerability, and efficacy of Goratirsen in patients with advanced NSCLC who have failed or are intolerant to standard treatments [3][4]. - The study included 119 NSCLC patients, with an independent review showing a confirmed objective response rate (cORR) of 49.6% (range: 40.2%-59.0%) and a disease control rate (DCR) of 86.3% (range: 78.7%-92.0%) [4]. - The median duration of response (DOR) was 14.5 months (range: 9.6-NE), median progression-free survival (PFS) was 8.2 months (range: 5.2-11.1), and median overall survival (OS) was 17.5 months (range: 13.6-NE) [4]. Group 3: Product Features and Future Developments - Goratirsen is the only KRAS G12C inhibitor approved in China that allows for once-daily oral administration, enhancing patient convenience [4]. - Ailis plans to commercialize Goratirsen and is conducting clinical studies for its use in combination with SHP2 inhibitors for first-line treatment of NSCLC, as well as for monotherapy in multiple tumor types [4].

Group 1 - The company's KRAS G12C inhibitor, citric acid gorasetinib (brand name "Airikai"), has received approval from the National Medical Products Administration for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations who have received at least one systemic therapy [1] - As of September 28, 2024, a total of 119 NSCLC patients were included in the analysis [1] - The confirmed objective response rate (cORR) assessed by the Independent Radiologic Review Committee (IRC) reached 49.6% (40.2%-59.0%) [1] - The disease control rate (DCR) was 86.3% (78.7%-92.0%) [1] - The median duration of response (DOR) was 14.5 months (9.6-NE) [1] - The median progression-free survival (PFS) was 8.2 months (5.2-11.1) [1] - The median overall survival (OS) was 17.5 months (13.6-NE) [1]