呋喹替尼胶囊 | China Drugs ListFruquintinib capsules | 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
- 爱优特 / FruzaqlaElunate / Fruzaqla
- 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
- 转移性结直肠癌 本品单药适用于既往接受过氟尿嘧啶类、奥沙利铂和伊立替康为基础的化疗,以及既往接受过或不适合接受抗血管内皮生长因子(VEGF)治疗、抗表皮生长因子受体(EGFR)治疗(RAS野生型)的转移性结直肠癌(mCRC)患者。 子宫内膜癌 本品联合信迪利单抗注射液用于既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整(pMMR)子宫内膜癌患者。 基于替代终点获得附条件批准上市,暂未获得临床终点数据,有效性和安全性尚待上市后进一步确证。本适应症的完全批准将取决于正在开展的确证性随机对照临床试验能否证实呋喹替尼胶囊联合信迪利单抗治疗临床获益。Metastatic colorectal cancer: monotherapy for patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and who have received or are unsuitable for anti-VEGF treatment and anti-EGFR treatment (for RAS wild-type disease). Endometrial cancer: with sintilimab for advanced mismatch repair-proficient (pMMR) disease after failure of systemic anticancer therapy, when curative surgery or curative radiotherapy is unsuitable. The endometrial indication has conditional approval based on a surrogate endpoint. Clinical endpoint data are not yet available, and efficacy and safety require further post-approval confirmation. Full approval depends on an ongoing confirmatory randomized controlled trial establishing clinical benefit with fruquintinib plus sintilimab.
- 适应症来源与口径
- 来源日期： 2025, 2026. 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。Source date(s): 2025, 2026. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label.
- 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
- 日本, 英国: 已取得当地获批／上市公告及官方价格来源。每条价格记录注明适应症与日期；未全面核查其他市场。Japan, United Kingdom: local approval / launch announcements and official price sources obtained. Indications and dates are specified in each price record; other markets not exhaustively reviewed.
- 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.既往接受过氟尿嘧啶类、奥沙利铂和伊立替康为基础的化疗，以及既往接受过或不适合接受抗血管内皮生长因子(VEGF)治疗、抗表皮生长因子受体(EGFR)治疗(RAS野生型)的转移性结直肠癌(mCRC)患者；2.联合信迪利单抗注射液用于既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整(pMMR)子宫内膜癌患者。Restricted to: (1) metastatic colorectal cancer after fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, in patients who have received or are unsuitable for anti-VEGF treatment and anti-EGFR treatment (for RAS wild-type disease); (2) Endometrial cancer: with sintilimab for advanced mismatch repair-proficient (pMMR) disease after failure of systemic anticancer therapy, when curative surgery or curative radiotherapy is unsuitable.
- 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.