甲磺酸阿美替尼片 | China Drugs ListAumolertinib mesylate tablets | China Drugs List
本页为公开参考信息，不构成医疗建议、处方或药品供应要约。请向持证专业人士确认当前批准情况、可获得性及适用性。
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 本品单药适用于: 用于 II-IIIB 期具有表皮生长因子受体(EGFR)外显子 19 缺失或外显子 21(L858R) 置换突变的成人非小细胞肺癌 (NSCLC)患者的治疗,患者须既往接受过手术切除治疗, 并由医生决定接受或不接受辅助化疗。 接受含铂放化疗期间或之后未出现疾病进展,及具有 EGFR 外显子 19 缺失或外显子 21(L858R)置换突变的局部晚期、不可切除(III 期)NSCLC 成人患者的治疗。 具有 EGFR 外显子 19 缺失或外显子 21(L858R)置换突变的局部晚期或转移性 NSCLC 成人患者的一线治疗。 既往经 EGFR 酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现疾病进展,并且经检测确认存在 EGFR T790M 突变阳性的局部晚期或转移性 NSCLC 成人患者的治疗。 本品联合培美曲塞和铂类化疗药物适用于: 具有 EGFR 外显子 19 缺失或外显子 21(L858R) 置换突变的局部晚期或转移性NSCLC 成人患者的一线治疗。As monotherapy: 1. Treatment of adults with stage II-IIIB NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation after surgical resection; receipt of adjuvant chemotherapy is determined by the treating physician. 2. Treatment of adults with locally advanced, unresectable stage III NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation whose disease has not progressed during or after platinum-based chemoradiotherapy. 3. First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or exon 21 L858R substitution mutation. 4. Treatment of adults with locally advanced or metastatic NSCLC with a confirmed EGFR T790M mutation whose disease progressed during or after treatment with an EGFR tyrosine kinase inhibitor (TKI). In combination with pemetrexed and platinum chemotherapy: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or exon 21 L858R substitution mutation.
- 适应症来源与口径
- 2026-01-05
- 说明书信息局限
- 已取得完整官方药品说明书。 中国大陆说明书。Complete official prescribing information obtained. Mainland China label.
- 中国可获得性状态
- 已核实中国历史批准记录；尚未逐项核查每个产品目前是否持续上市销售。Historical Chinese approval verified; current continuous market availability has not been checked for every product.
- 海外状态
- 英国MHRA于2025年6月3日批准AUMSEQA。尚未取得可核实的公开数值价格；未全面核查其他市场。UK MHRA approval: AUMSEQA, 3 June 2025. No verified public numeric price obtained; other markets not exhaustively reviewed.
- 医保分类
- 已纳入国家医保（乙类）Included in national insurance (Category B)
- 医保版本
- 2025版；2026年1月1日起执行2025 edition; effective 1 January 2026
- 医保限制
- 限：1.表皮生长因子受体(EGFR)外显子19缺失或外显子21(L858R)置换突变的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的一线治疗；2.既往经EGFR酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现疾病进展，并且经检测确认存在EGFRT790M突变阳性的局部晚期或转移性非小细胞肺癌成人患者的治疗；3.既往接受过手术切除治疗的II-IIIB期具有表皮生长因子受体(EGFR)外显子19缺失或外显子21(L858R)置换突变的成人非小细胞肺癌(NSCLC)患者的治疗；4.接受含铂放化疗期间或之后未出现疾病进展，及具有EGFR外显子19缺失或外显子21(L858R)置换突变的局部晚期、不可切除(III期)NSCLC成人患者的治疗。Limited to: 1. First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or exon 21 L858R substitution mutation. 2. Treatment of adults with locally advanced or metastatic NSCLC with a confirmed EGFR T790M mutation whose disease progressed during or after treatment with an EGFR tyrosine kinase inhibitor (TKI). 3. Treatment after surgical resection in adults with stage II-IIIB NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation. 4. Treatment of adults with locally advanced, unresectable stage III NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation whose disease has not progressed during or after platinum-based chemoradiotherapy.
- 医保期限
- 2026-01-01 至 2026-12-312026-01-01 to 2026-12-31
- 医保核查说明
- 按成分／剂型名称精确或标准化匹配。报销仍取决于剂型及目录所列支付限制。Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.