卡度尼利单抗注射液 | China Drugs ListCadonilimab 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。
- 商品名
- 开坦尼Kaitanni
- 企业
- 康方药业Akeso Pharmaceuticals
- 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
- 宫颈癌：①单药用于既往接受含铂化疗失败的复发或转移性宫颈癌；②联合紫杉醇和铂类化疗药物，联合或不联合贝伐珠单抗，用于持续、复发或转移性宫颈癌的一线治疗。胃/胃食管结合部腺癌：联合含氟尿嘧啶类和铂类药物化疗，用于局部晚期不可切除或转移性胃或胃食管结合部腺癌的一线治疗。Cervical cancer: (1) monotherapy for recurrent or metastatic disease after failure of platinum-based chemotherapy; (2) with paclitaxel and platinum-based chemotherapy, with or without bevacizumab, as first-line treatment of persistent, recurrent or metastatic disease. Gastric or gastroesophageal junction adenocarcinoma: with fluoropyrimidine- and platinum-based chemotherapy as first-line treatment of locally advanced unresectable or metastatic disease.
- 适应症来源与口径
- 来源日期： 2025-05-27, 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): 2025-05-27, 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.既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗；2.联合紫杉醇和铂类化疗药物联合或不联合贝伐珠单抗用于持续、复发或转移性宫颈癌的一线治疗；3.联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性胃或胃食管结合部腺癌患者的一线治疗。Restricted to: (1) recurrent or metastatic cervical cancer after failure of platinum-based chemotherapy; (2) use with paclitaxel and platinum-based chemotherapy, with or without bevacizumab, as first-line treatment of persistent, recurrent or metastatic cervical cancer; (3) use with fluoropyrimidine- and platinum-based chemotherapy as first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- 医保期限
- 2026-01-01 至 2026-12-312026-01-01 to 2026-12-31
- 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.
来源
- https://www.nmpa.gov.cn/directory/web/nmpa/zhuanti/cxylqx/cxypxx/20220629135936153.html
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://akesobio.com/media/2632/%E5%8D%A1%E5%BA%A6%E5%B0%BC%E5%88%A9%E5%8D%95%E6%8A%97%E6%B3%A8%E5%B0%84%E6%B6%B2%E8%AF%B4%E6%98%8E%E4%B9%A6-2506%E7%89%88.pdf