依沃西单抗注射液 | China Drugs ListIvonescimab 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
- 康方赛诺医药有限公司Akeso Sino Pharmaceutical 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. 联合培美曲塞和卡铂，用于经EGFR酪氨酸激酶抑制剂治疗后进展、EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌患者。 2. 单药用于经国家药监局批准的检测评估为PD-L1肿瘤比例分数（TPS）≥1%、EGFR突变阴性和ALK阴性的局部晚期或转移性非小细胞肺癌患者的一线治疗。 3. 联合紫杉醇和卡铂，用于不可切除的局部晚期或转移性鳞状非小细胞肺癌患者的一线治疗。1. In combination with pemetrexed and carboplatin, for patients with EGFR mutation-positive locally advanced or metastatic nonsquamous NSCLC that has progressed after EGFR TKI therapy. 2. As monotherapy for first-line treatment of locally advanced or metastatic NSCLC without EGFR mutations or ALK alterations and with PD-L1 tumor proportion score (TPS) >=1%, assessed using an NMPA-approved test. 3. With paclitaxel and carboplatin for first-line treatment of unresectable locally advanced or metastatic squamous NSCLC.
- 适应症来源与口径
- 来源日期： 2026. 生产商面向中国大陆的药品说明书。 批准或修订日期为空或为占位值；尚未确认准确修订日期。Source date(s): 2026. Manufacturer prescribing information for Mainland China. An approval or revision date is blank or a placeholder; the exact revision date is not confirmed.
- 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.联合培美曲塞和卡铂，用于经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)患者的治疗；2.经国家药品监督管理局批准的检测评估为PD-L1肿瘤比例分数(TPS)≥1%的表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性的局部晚期或转移性非小细胞肺癌一线治疗。Limited to: 1. In combination with pemetrexed and carboplatin, for patients with EGFR mutation-positive locally advanced or metastatic nonsquamous NSCLC that has progressed after EGFR TKI therapy. 2. First-line treatment of locally advanced or metastatic NSCLC without EGFR mutations or ALK alterations and with PD-L1 TPS >=1%, assessed using an NMPA-approved test.
- 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.