注射用瑞康曲妥珠单抗 | China Drugs ListTrastuzumab rezetecan 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
- 苏州盛迪亚生物医药有限公司Suzhou Suncadia Biopharmaceuticals 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. 单药用于存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除局部晚期或转移性非小细胞肺癌成人患者；该适应症为附条件批准，完全批准取决于确证性研究结果。 2. 单药用于既往接受过至少一种抗HER2治疗的局部晚期或转移性HER2阳性乳腺癌成人患者。 3. 单药用于既往接受过奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2阳性结直肠癌成人患者。1. Monotherapy for adults with unresectable locally advanced or metastatic NSCLC with an activating HER2 (ERBB2) mutation who have received at least one systemic therapy. This indication has conditional approval; full approval depends on confirmatory study results. 2. Monotherapy for adults with locally advanced or metastatic HER2-positive breast cancer who have received at least one anti-HER2 treatment. 3. Monotherapy for adults with HER2-positive colorectal cancer after failure of oxaliplatin, fluorouracil and irinotecan.
- 适应症来源与口径
- 来源日期： 2026-08-04. 生产商面向中国大陆的药品说明书。Source date(s): 2026-08-04. Manufacturer prescribing information for Mainland China.
- 说明书信息局限
- 已取得完整官方药品说明书。 中国大陆说明书。Complete official prescribing information obtained. Mainland China label.
- 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
- 限存在HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。Limited to adults with unresectable locally advanced or metastatic NSCLC with an activating HER2 (ERBB2) mutation who have received at least one systemic therapy.
- 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.