斯鲁利单抗注射液 | China Drugs ListSerplulimab 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。
- 商品名
- 汉斯状Hansizhuang
- 企业
- 复宏汉霖Shanghai Henlius Biotech
- 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
- 非小细胞肺癌鳞状非小细胞肺癌本品联合卡铂和白蛋白紫杉醇适用于不可手术切除的局部晚期或转移性鳞状非小细胞肺癌(NSCLC)的一线治疗。 非鳞状非小细胞肺癌本品联合培美曲塞和卡铂适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) 阴性的不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)的一线治疗。 小细胞肺癌本品联合卡铂和依托泊苷适用于广泛期小细胞肺癌 (ES-SCLC) 的一线治疗。 食管鳞状细胞癌本品联合含氟尿嘧啶类和铂类药物用于 PD-L1 阳性的不可切除局部晚期/复发或转移性食管鳞状细胞癌(ESCC)的一线治疗。 胃癌本品联合奥沙利铂和替吉奥用于肿瘤 PD-L1 表达 CPS≥5 的可手术切除的胃癌新辅助及手术后本品单药辅助治疗。Non-small cell lung cancer (NSCLC): (1) with carboplatin and albumin-bound paclitaxel as first-line treatment of unresectable locally advanced or metastatic squamous NSCLC; (2) with pemetrexed and carboplatin as first-line treatment of unresectable locally advanced or metastatic nonsquamous NSCLC with negative EGFR mutation and ALK status. Small cell lung cancer: with carboplatin and etoposide as first-line treatment of extensive-stage SCLC. Esophageal squamous cell carcinoma: with a fluoropyrimidine and a platinum agent as first-line treatment of PD-L1-positive unresectable locally advanced, recurrent or metastatic disease. Gastric cancer: with oxaliplatin and S-1 as neoadjuvant treatment for resectable gastric cancer with tumor PD-L1 expression CPS >=5, followed by serplulimab monotherapy as postoperative adjuvant treatment.
- 适应症来源与口径
- 来源日期： 2026-06-09, 2026. 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): 2026-06-09, 2026. 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
- 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。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
- 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.