舒格利单抗注射液 | China Drugs ListSugemalimab 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
- 非小细胞肺癌: 1. 【联合治疗】:1本品联合培美曲塞和卡铂用于表皮生长因子受体( EGFR )基因突变阴性和间变性淋巴瘤激酶( ALK )阴性的转移性非鳞状非小细胞肺癌( NSCLC )患者的一线治疗。2本品联合紫杉醇和卡铂用于转移性鳞状非小细胞肺癌( NSCLC )患者的一线治疗。 2. 【单药治疗】:本品用于在接受铂类药物为基础的同步或序贯放化疗后未出现疾病进展的、不可切除、III期非小细胞肺癌( NSCLC )患者的治疗。 结外 NK/T 细胞淋巴瘤:本品单药用于治疗复发或难治性结外 NK/T 细胞淋巴瘤( R/R ENKTL )成人患者。 食管鳞癌:本品联合氟尿嘧啶类和铂类化疗药物用于不可切除的局部晚期、复发或转移性食管鳞状细胞癌( ESCC )的一线治疗。胃及胃食管结合部腺癌:本品联合含氟尿嘧啶类和铂类药物化疗用于表达 PD-L1 (综合阳性评分 [CPS]≥5 )的不可手术切除的局部晚期或转移性胃及胃食管结合部腺癌的一线治疗。1. Non-small cell lung cancer (NSCLC): with pemetrexed and carboplatin for first-line treatment of metastatic nonsquamous NSCLC without EGFR mutations or ALK alterations; with paclitaxel and carboplatin for first-line treatment of metastatic squamous NSCLC. As monotherapy for unresectable stage III NSCLC that has not progressed after concurrent or sequential platinum-based chemoradiotherapy. 2. As monotherapy for adults with relapsed or refractory extranodal NK/T-cell lymphoma. 3. With fluoropyrimidine and platinum chemotherapy for first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma. 4. With fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (combined positive score [CPS] >=5).
- 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
- 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
- 英国MHRA于2024年10月30日批准EQJUBI。尚未取得可核实的公开数值价格；未全面核查其他市场。UK MHRA approval: EQJUBI, 30 October 2024. No verified public numeric price obtained; other markets not exhaustively reviewed.
- 医保分类
- 2025国家医保目录未匹配；待人工复核Not matched in the 2025 national list; manual review pending
- 医保版本
- 2025版；2026年1月1日起执行2025 edition; effective 1 January 2026
- 医保核查说明
- 未在提取的目录中匹配到，并不证明被排除。复方制剂仍需人工复核。No match in the extracted directory is not proof of exclusion. Compound formulations still require manual review.