注射用泽尼达妥单抗 | China Drugs ListZanidatamab 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。
- 企业
- 百济神州（苏州）生物科技有限公司BeiGene (Suzhou) Biotechnology 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
- 本品适用于既往接受过全身治疗的 HER2 高表达( IHC3+ )的不可切除局部晚期或转移性胆道癌患者。For previously systemically treated, HER2-high (IHC 3+) unresectable locally advanced or metastatic biliary tract cancer.
- 适应症来源与口径
- 来源日期： 2025. 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。 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): 2025. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label. 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
- 已取得完整官方药品说明书。 现有完整说明书来自海外辖区；尚未取得完整的中国现行说明书。中国适应症另由中国来源支持。Complete official prescribing information obtained. The available full label is from an overseas jurisdiction; a complete current Chinese label remains unavailable. Chinese indications are supported separately by Chinese sources.
- 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
- 未纳入基本医保；已入2025商保创新药目录Commercial insurance list only; not included in basic insurance
- 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
- 商保目录不由基本医保基金支付；具体商业保险以合同为准The commercial-insurance formulary is not funded by basic medical insurance; coverage depends on the individual commercial insurance contract.
- 医保核查说明
- 商业保险目录精确匹配；基本医保通知排除支付。Exact match in the commercial insurance list; the basic insurance notice excludes payment.