注射用芦比替定 | China Drugs ListLurbinectedin 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
- Zepzelca
- 企业
- Jazz Pharmaceuticals, Inc.
- 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
- 美国处方资料：与阿替利珠单抗或阿替利珠单抗/透明质酸酶-tqjs联合，作为成人广泛期小细胞肺癌的维持治疗，要求采用相应阿替利珠单抗产品、卡铂和依托泊苷进行一线诱导后未进展。2026年9月说明书移除了此前加速批准的转移性SCLC适应症。这是美国说明书内容，不代表中国适应症已获确认。US prescribing information: with atezolizumab or atezolizumab/hyaluronidase-tqjs, as maintenance treatment for adults with extensive-stage small cell lung cancer that has not progressed after first-line induction using the corresponding atezolizumab product, carboplatin and etoposide. The September 2026 label removes the prior accelerated-approval metastatic SCLC indication. This is US labeling, not confirmation of Chinese indications.
- 适应症来源与口径
- 修订于 09/2026； 更新于 2026-09-30. 部分境外适应症；不确立中国批准范围。Revised 09/2026; updated 2026-09-30. 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、现行中国适应症及持续在售情况。Chinese approval, current Chinese indications and continuous market availability were not 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://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=632bb50c-3bcb-4c85-9056-fc33410550ae
- Zepzelca——DailyMed所载Jazz完整美国处方资料Zepzelca — Jazz full US prescribing information on DailyMed
Official prescribing information · Revised 09/2026; updated 2026-09-30
已打开厂商完整说明书。此前加速批准的转移性SCLC适应症于2026年9月移除；维持联合治疗适应症仍保留。Complete manufacturer label opened. The prior metastatic SCLC accelerated-approval indication was removed in September 2026; the maintenance combination indication remains.
- FDA批准芦比替定联合维持治疗广泛期SCLCFDA approval of lurbinectedin maintenance combination for extensive-stage SCLC
Regulatory approval announcement · 2025-10-02
已打开FDA一手公告；仅涉及美国适应症。Primary FDA announcement opened; US indication only.
证据核查日期：