甲磺酸贝福替尼胶囊 | China Drugs ListBefotertinib mesylate capsules | 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。
- 企业
- 贝达药业股份有限公司Betta Pharmaceuticals Co., Ltd.
- 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
- 本品适用于:具有表皮生长因子受体(EGFR)外显子19缺失或外显子21(L858R)置换突变的局部晚期或转移性非小细胞肺癌(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。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).
- 适应症来源与口径
- 来源日期： 2025, 2026. 适应症转录自国家医保局公开的企业申报资料；不代表已核实完整的现行说明书。Source date(s): 2025, 2026. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label.
- 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。 完整文件为较旧版本；较新适应症由另行公告或申报资料支持。Complete official prescribing information obtained. Mainland China label. The full document is an older version; newer indications are supported by separate announcements or submissions.
- 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
- 待逐一核查各市场。Market-by-market verification pending.
- 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.既往因表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现疾病进展，并且经检验确认存在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。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).
- 医保期限
- 2026-01-01 至 2027-12-312026-01-01 to 2027-12-31
- 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.