贝莫苏拜单抗注射液 | China Drugs ListBenmelstobart 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
- 正大天晴药业集团南京顺欣制药有限公司Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin 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联合盐酸安罗替尼、卡铂和依托泊苷，用于广泛期小细胞肺癌的一线治疗。②单药用于接受含铂同步或序贯放化疗后未出现疾病进展、无已知EGFR敏感突变或ALK重排的不可切除III期非小细胞肺癌。③联合盐酸安罗替尼，用于既往系统性抗肿瘤治疗失败且不适合根治性手术或放疗的非MSI-H或非dMMR复发性或转移性子宫内膜癌，为附条件批准。④联合盐酸安罗替尼用于晚期肾细胞癌一线治疗。⑤联合盐酸安罗替尼用于不可切除或转移性腺泡状软组织肉瘤成人患者，为附条件批准。【较后版本联合药说明书补充】2026-08-21版盐酸安罗替尼说明书另列：贝莫苏拜联合紫杉醇和卡铂后，序贯安罗替尼联合贝莫苏拜，用于局部晚期或转移性鳞状非小细胞肺癌一线治疗；贝莫苏拜官网下载原件仍为2026-04-14版。(1) With anlotinib hydrochloride, carboplatin and etoposide as first-line treatment of extensive-stage small cell lung cancer. (2) Monotherapy for unresectable stage III non-small cell lung cancer without a known sensitizing EGFR mutation or ALK rearrangement, with no progression after platinum-based concurrent or sequential chemoradiotherapy. (3) With anlotinib hydrochloride for non-MSI-H or non-dMMR recurrent or metastatic endometrial cancer after failure of systemic anticancer therapy, when curative surgery or radiotherapy is unsuitable; conditionally approved. (4) With anlotinib hydrochloride as first-line treatment of advanced renal cell carcinoma. (5) With anlotinib hydrochloride for adults with unresectable or metastatic alveolar soft part sarcoma; conditionally approved. Supplement from the later companion-drug label: the anlotinib label dated August 21, 2026 also lists benmelstobart with paclitaxel and carboplatin, followed sequentially by anlotinib plus benmelstobart, as first-line treatment of locally advanced or metastatic squamous NSCLC. The downloadable original benmelstobart label remains dated April 14, 2026.
- 适应症来源与口径
- 来源日期： 2026-04-14, 2026-10-23, 2026-08-21. 生产商面向中国大陆的药品说明书。 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。 证据核查日期：2026年10月23日。Source date(s): 2026-04-14, 2026-10-23, 2026-08-21. Manufacturer prescribing information for Mainland China. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources. Evidence review: 23 October 2026.
- 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
- 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.