注射用维迪西妥单抗 | China Drugs ListDisitamab vedotin 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。
- 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
- 胃癌：用于至少接受过2个系统化疗方案的HER2过表达（IHC 2+或3+）局部晚期或转移性胃癌，包括胃食管结合部腺癌；该适应症为附条件批准。尿路上皮癌：①单药用于既往接受过含铂化疗的HER2过表达（IHC 2+或3+）局部晚期或转移性尿路上皮癌；②联合特瑞普利单抗，用于HER2表达（IHC 1+、2+或3+）的局部晚期或转移性尿路上皮癌。乳腺癌：①用于既往接受过曲妥珠单抗（或其生物类似药）和紫杉类药物治疗、HER2阳性且存在肝转移的晚期乳腺癌；②用于既往在转移性疾病阶段接受过至少一种系统治疗，或在辅助化疗期间或完成辅助化疗后12个月内复发的不可切除或转移性HER2低表达（IHC 1+或IHC 2+/ISH−）且存在肝转移的成人乳腺癌患者。Gastric cancer: for HER2-overexpressing (IHC 2+ or 3+) locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, after at least two systemic chemotherapy regimens; this indication is conditionally approved. Urothelial carcinoma: (1) monotherapy for HER2-overexpressing (IHC 2+ or 3+) locally advanced or metastatic disease after platinum-based chemotherapy; (2) with toripalimab for HER2-expressing (IHC 1+, 2+ or 3+) locally advanced or metastatic disease. Breast cancer: (1) HER2-positive advanced breast cancer with liver metastases after trastuzumab (or a biosimilar) and a taxane; (2) adults with unresectable or metastatic HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-negative) and liver metastases, after at least one systemic treatment in the metastatic setting, or recurrence during adjuvant chemotherapy or within 12 months after completing it.
- 适应症来源与口径
- 来源日期： 2026-04-07, 2026-10-23. 生产商面向中国大陆的药品说明书。 证据核查日期：2026年10月23日。Source date(s): 2026-04-07, 2026-10-23. Manufacturer prescribing information for Mainland China. Evidence review: 23 October 2026.
- 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：1.至少接受过2个系统化疗的HER2过表达局部晚期或转移性胃癌(包括胃食管结合部腺癌)；2.既往接受过含铂化疗且HER2过表达局部晚期或转移性尿路上皮癌。Restricted to: (1) HER2-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, after at least two systemic chemotherapy regimens; (2) HER2-overexpressing locally advanced or metastatic urothelial carcinoma after platinum-based chemotherapy.
- 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.