氟泽雷塞片 | China Drugs ListFulzerasib tablets | 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
- 信达生物科技有限公司Innovent Biologics Co., Ltd.
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 本品适用于治疗至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因( KRAS ) G12C 突变型的晚期非小细胞肺癌( NSCLC )成人患者。上述适应症是基于一项单臂临床试验结果获得的附条件批准。本适应症的完全批准将取决于确证性临床试验的临床获益。Treatment of adults with advanced NSCLC harboring a KRAS G12C mutation who have received at least one systemic therapy. This indication received conditional approval based on a single-arm clinical trial. Full approval depends on confirmation of clinical benefit in a confirmatory trial.
- 适应症来源与口径
- 无法从原文件确认修订日期。The revision date could not be confirmed from the original file.
- 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
- 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
- 限至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因(KRAS)G12C突变型的晚期非小细胞肺癌(NSCLC)成人患者。Limited to adults with advanced KRAS G12C-mutated NSCLC who have received at least one systemic therapy.
- 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.