注射用佐妥昔单抗 | China Drugs ListZolbetuximab for 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
- Astellas PharmaEurope B.V.Astellas Pharma Europe B.V.
- 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
- 联合含氟尿嘧啶类和铂类药物化疗，用于CLDN18.2阳性、HER2阴性的局部晚期不可切除或转移性胃或胃食管交界处腺癌患者的一线治疗。患者选择需经验证的检测确认：CLDN18.2阳性定义为免疫组化显示≥75%肿瘤细胞有中度至强的CLDN18膜染色。In combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patient selection requires a validated test: CLDN18.2 positivity is defined as moderate-to-strong membranous CLDN18 staining in at least 75% of tumor cells by immunohistochemistry.
- 适应症来源与口径
- 来源日期： 2024-12-25, 2026-10-23. 生产商面向中国大陆的药品说明书。 证据核查日期：2026年10月23日。Source date(s): 2024-12-25, 2026-10-23. Manufacturer prescribing information for Mainland China. 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
- 日本: 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。Japan: 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.