吡洛西利片 | China Drugs ListBireociclib 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。
- 企业
- 轩竹生物科技股份有限公司Xuanzhu Biopharmaceutical 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
- HR阳性、HER2阴性局部晚期或转移性乳腺癌:（1）联合芳香化酶抑制剂用于初始内分泌治疗;（2）联合氟维司群用于既往内分泌治疗后进展者;（3）单药用于转移性阶段接受过至少两种内分泌治疗及一种化疗后进展者。For HR-positive, HER2-negative locally advanced or metastatic breast cancer: (1) with an aromatase inhibitor as initial endocrine therapy; (2) with fulvestrant after progression on previous endocrine therapy; or (3) as monotherapy after progression following at least two endocrine treatments and one chemotherapy regimen in the metastatic setting.
- 适应症来源与口径
- 来源日期： 2026-04, 2026-03. 包括由获批公告支持的适应症；适用说明书版本请见链接来源。 新增适应症可能由较新的公告或申报资料支持，而非旧版完整说明书；请查看适应症来源。Source date(s): 2026-04, 2026-03. Includes indications supported by approval announcements; see the linked sources for the applicable label version. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources.
- 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.与氟维司群联合用于既往接受内分泌治疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性晚期或转移性乳腺癌成人患者；2.既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性晚期或转移性乳腺癌成人患者。Restricted to: (1) With fulvestrant for adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. (2) Adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has progressed after at least two endocrine treatments and one chemotherapy regimen in the metastatic setting.
- 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.