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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
四川科伦博泰生物医药股份有限公司Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
药品类型
生物药Biologic
治疗领域
肿瘤科Oncology
公开来源记录的适应症
( 1 )【三阴性乳腺癌】本品用于既往至少接受过 2 种系统治疗 ( 其中至少 1 种治疗针对晚期或转移性阶段 ) 的不可切除的局部晚期或转移性三阴性乳腺癌成人患者;( 2 )【非小细胞肺癌】本品用于经表皮生长因子受体 (EGFR) 酪氨酸激酶抑制剂 (TKI) 和含铂化疗治疗后进展的 EGFR 基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌( NSCLC )成人患者的治疗(1) Adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic treatments, including at least one for advanced or metastatic disease. (2) Adults with EGFR mutation-positive locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that has progressed after an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
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
适应症已与官方公开申报资料核对。尚未取得完整原始说明书。Indications checked against an official public submission. The full original prescribing information is still unavailable.
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.既往至少接受过2种系统治疗(其中至少1种治疗针对晚期或转移性阶段)的不可切除的局部晚期或转移性三阴性乳腺癌成人患者;2.经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)和含铂化疗治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)成人患者。Restricted to: (1) Adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic treatments, including at least one for advanced or metastatic disease. (2) Adults with EGFR mutation-positive locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that has progressed after an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
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.

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