格菲妥单抗注射液 | China Drugs ListGlofitamab 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
- Roche Pharma(Schweiz) AGRoche Pharma (Schweiz) AG
- 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本品单药适用于治疗既往接受过至少两线系统性治疗的复发或难治性弥漫大 B 细胞淋巴瘤( DLBCL )成人患者。 2本品联合吉西他滨与奥沙利铂适用于治疗不适合自体造血干细胞移植( ASCT )的复发或难治性弥漫大 B 细胞淋巴瘤非特指型( DLBCL NOS )成人患者。1. Monotherapy for adults with relapsed or refractory DLBCL who have received at least two lines of systemic therapy. 2. With gemcitabine and oxaliplatin for adults with relapsed or refractory DLBCL NOS who are ineligible for autologous stem-cell transplantation (ASCT).
- 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。 现有完整说明书来自海外辖区；尚未取得完整的中国现行说明书。中国适应症另由中国来源支持。Complete official prescribing information obtained. The available full label is from an overseas jurisdiction; a complete current Chinese label remains unavailable. Chinese indications are supported separately by Chinese sources.
- 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.既往接受过至少两线系统性治疗的复发或难治性弥漫大B细胞淋巴瘤(DLBCL)成人患者;2.不适合自体造血干细胞移植(ASCT)的复发或难治性弥漫大B细胞淋巴瘤非特指型(DLBCLNOS)成人患者。Limited to: 1. Adults with relapsed or refractory DLBCL after at least two lines of systemic therapy. 2. Adults with relapsed or refractory DLBCL NOS who are ineligible for ASCT.
- 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.