瑞基奥仑赛注射液 | China Drugs ListRelmacabtagene autoleucel 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
- 1 、经过二线或以上系统性治疗后成人患者的复发或难治性大 B 细胞淋巴瘤,包括弥漫性大 B 细胞淋巴瘤非特指型、滤泡性淋巴瘤转化的弥漫性大 B 细胞淋巴瘤、 3b 级滤泡性淋巴瘤、原发纵隔大 B 细胞淋巴瘤、高级别 B 细胞淋巴瘤伴 MYC 和 BCL2 和 / 或 BCL-6 重排(双打击 / 三打击淋巴瘤)。本品适应症为附条件批准上市,更多的有效性和安全性数据待上市后研究提供。 2 、经过二线或以上系统性治疗的成人难治性或 24 个月内复发的滤泡性淋巴瘤,包括组织学分级为 1 、 2 、 3a 级的滤泡性淋巴瘤。本品适应症为附条件批准上市,更长时间的有效性数据待上市后研究提供。 3 、经过包括布鲁顿酪氨酸激酶抑制剂( BTKi) 治疗在内的二线及以上系统性治疗的成人复发或难治性套细胞淋巴瘤。本适应症为附条件批准上市, 更长时间的有效性数据待上市后研究提供。1. Adults with relapsed or refractory large B-cell lymphoma after at least two lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), DLBCL transformed from follicular lymphoma, grade 3b follicular lymphoma, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit/triple-hit lymphoma). This indication has conditional approval; additional efficacy and safety data are awaited from postmarketing studies. 2. Adults with follicular lymphoma (histologic grades 1, 2 or 3a) that is refractory or relapses within 24 months, after at least two lines of systemic therapy. This indication has conditional approval; longer-term efficacy data are awaited from postmarketing studies. 3. Adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a Bruton tyrosine kinase inhibitor (BTKi). This indication has conditional approval; longer-term efficacy data are awaited from postmarketing studies.
- 适应症来源与口径
- 来源日期： 2025. 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。 新增适应症可能由较新的公告或申报资料支持，而非旧版完整说明书；请查看适应症来源。Source date(s): 2025. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources.
- 说明书信息局限
- 适应症已与官方公开申报资料核对。尚未取得完整原始说明书。Indications checked against an official public submission. The full original prescribing information is still unavailable.
- 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
- 未纳入基本医保；已入2025商保创新药目录Commercial insurance list only; not included in basic insurance
- 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
- 商保目录不由基本医保基金支付；具体商业保险以合同为准Inclusion in the commercial insurance drug list does not imply payment by the basic medical insurance fund. Commercial insurance coverage depends on the individual policy.
- 医保核查说明
- 商业保险目录精确匹配；基本医保通知排除支付。Exact match in the commercial insurance list; the basic insurance notice excludes payment.