| 突破性治疗申请公示详细信息 | | | | | --- | --- | --- | --- | | 受理号 CXHL2300625 | | 药品名称 | 甲磺酸伏美替尼片 | | 药品类型 化药 | | 注册分类 | 2.4 | | 申请日期 2025-11-18 | | 承か日期 | 2023-06-08 | | 公示日期 2025-12-25 | | 公示截止日期 | 2026-01-04 | | 是否为罕见病药 台 物 | | | | | 拟定适应症 (或 功能主治) 线治疗。 | | 本品适用于具有表皮生长因子受体 (EGFR) PACC突变的同部晚期或转移性非小细胞肺癌 (NSCLC)成人患者的一 | | | 理由及依据 | 三个文件的公告》(2020年第82号),同意纳入突破治疗药物程序。 | 经审核,本申请符合《药品注册管理办法》和《国家药监局关于发布《突破性治疗药物审评工作程序(试行) 〉等 | | 截图来源：CDE 官网 伏美替尼是第三代 EGFR-TKI，此前已在国内获批两项适应症，用于 EGFR 突变的局部晚期或转移性 NSCLC 成人患者的二线、 一线治疗。今年 7 月，伏美替尼的 ...

Core Insights - Lung nodules have become common in health check reports, with most being benign, but regular follow-ups are essential based on nodule characteristics [1][2] Group 1: Lung Nodule Management - 95% of lung nodules are benign, with only 5% having the potential for malignancy [2] - Recommendations for follow-up include: - Ground-glass nodules under 5mm should be reviewed every six months - Nodules between 5mm and 1cm should be followed up every three months - Mixed nodules under 8mm should follow a 3-6-12 month follow-up schedule, while those over 8mm may require intervention [2] - Solid nodules require comprehensive evaluation based on size and edge characteristics, with anti-inflammatory treatment potentially ruling out malignancy if nodules shrink [2] Group 2: Lung Cancer Risk Factors - Lung cancer has the highest incidence and mortality rates among all malignancies in China, with primary risk factors including smoking, occupational exposure, and chronic lung diseases [3] - Smoking significantly increases cancer risk, with smokers having a 4-10 times higher mortality rate compared to non-smokers [3] - Passive smoking and occupational exposures, such as asbestos and air pollution, also contribute to increased risk [3] Group 3: Lung Cancer Treatment Approaches - The pathological classification of lung cancer determines treatment strategies, with small cell lung cancer (15% of cases) being highly malignant but treatable with combined therapies extending median survival from 18 months to 55.9 months [4] - Immunotherapy combined with chemotherapy has become a first-line treatment for extensive small cell lung cancer, achieving an objective response rate of 60%-70% [4] - Despite advancements in targeted and immunotherapy, chemotherapy remains a crucial treatment method, with modern regimens improving management of side effects [4]