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]