注射用恩美曲妥珠单抗 | China Drugs ListTrastuzumab emtansine for injection | 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。
其他
- 商品名
- Kadcyla
- 企业
- Genentech, Inc.
- 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
- 美国单药适应症涵盖既往接受曲妥珠单抗和紫杉类药物的HER2阳性转移性乳腺癌，要求曾接受转移性阶段治疗，或在辅助治疗期间或结束后六个月内复发。辅助用途也涵盖术前接受含紫杉类和曲妥珠单抗方案后仍有残余浸润性病灶的HER2阳性早期乳腺癌。须采用获准的HER2检测方法。US single-agent indications cover HER2-positive metastatic breast cancer after trastuzumab and a taxane, with prior metastatic therapy or recurrence during or within six months of adjuvant treatment. Adjuvant use also covers HER2-positive early breast cancer with residual invasive disease after preoperative taxane and trastuzumab-based treatment. An authorized HER2 test is required.
- 适应症来源与口径
- 美国处方资料 修订于 2026年3月. 部分境外适应症；不确立中国批准范围。US prescribing information revised March 2026. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接境外官方处方资料；尚未核实完整的现行中国说明书。Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- 中国可获得性状态
- 本次英文来源核查未独立核实中国批准详情及当前供应情况。Chinese approval details and current availability have not been independently verified in this English-source review.
- 海外状态
- 请参阅所链接的境外监管机构或厂商证据。批准及适应症因司法辖区而异；尚未确认当前供应情况。See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- 医保分类
- 尚未核实Not yet verified
- 医保版本
- 中国国家医保信息待核实Chinese national insurance review pending
- 医保核查说明
- 本次新增记录尚未确定报销资格；缺少信息不代表未被纳入。No reimbursement determination was made for this addition; missing information is not proof of exclusion.
来源
- https://www.gene.com/download/pdf/kadcyla_prescribing.pdf
- Kadcyla——美国处方资料Kadcyla — US prescribing information
Official prescribing information · US prescribing information revised March 2026
已于2026年11月2日打开英文一手来源。本摘要列出部分美国适应症，并非现行中国批准范围的全集。English primary source opened on 2 November 2026. The summary lists selected US indications, not the complete current Chinese approved scope.
- FDA NDC目录——包装参考FDA NDC directory — packaging reference
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
- 得克萨斯州卫生服务部（DSHS）——2026年度WAC报告Texas DSHS — 2026 annual WAC report
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
- 深圳新风和睦家医院——公示价格Shenzhen New Frontier United Family Hospital — public prices
Supplied report reference · Report dated 25 October 2026
保留原报告引用以便追溯。仅凭此引用不能核实中国批准、品牌身份、制剂等效性或同口径价格。WAC计价单位及包装换算须另行确认。Original report citation retained for traceability. This citation alone does not verify Chinese approval, brand identity, equivalent formulations or like-for-like prices. WAC unit and pack conversions require separate confirmation.
证据核查日期：