肿瘤综合治疗电子杂志2026，Vol.12Issue(1)：22-33,12.DOI:10.12151/JMCM.2026.01-04
2025年中国新上市抗实体瘤药物年度盘点:靶点、循证医学证据与发展趋势
Annual review of novel anti-solid tumor drugs approved in China in 2025:molecular targets,evidence-based medicine,and development trends
摘要
Abstract
This article reviews 33 novel anti-solid tumor drugs approved by the National Medical Products Administration(NMPA)in 2025,collecting detailed information and conducting comprehensive analysis.Statistical results show that nearly half of these new drugs target refractory molecular subtypes,including EGFR exon 20 insertion mutations,HER-2-activating mutations,KRAS G12C variations,and NTRK gene fusions,aligning with clinical needs where current treatment options are limited in later-line settings.By integrating public regulatory documents and phase Ⅲ clinical trial data,this study explores the mechanisms of action of these innovative drugs,summarizes existing evidence-based medical evidence,and analyzes their potential for clinical application.The applicable indications cover multiple cancer types,including lung cancer,breast cancer,digestive system tumors,urinary system tumors,and various rare solid tumors.These new drugs have achieved significant progress in efficacy,with objective response rates in later-line treatment for multiple cancers improving from less than 20%to over 40%.However,long-term safety data for some drugs still require observation in real-world settings.From a clinical perspective,they provide more feasible options for patients who previously had difficulty obtaining better treatments,but the core challenge lies in establishing precise correlations among molecular testing,evidence-based strength,and individual patient characteristics.The popularization of molecular testing,medical insurance coverage,and real-world observations will be key factors influencing the widespread clinical application of these drugs.关键词
实体瘤/创新药物/靶向治疗/免疫治疗/抗体药物偶联物Key words
Solid tumor/Innovative drugs/Targeted therapy/Immunotherapy/Antibody-drug conjugate引用本文复制引用
刘超然,高静,段丽芳,陈佳音,袁劲松,王树滨..2025年中国新上市抗实体瘤药物年度盘点:靶点、循证医学证据与发展趋势[J].肿瘤综合治疗电子杂志,2026,12(1):22-33,12.基金项目
深圳市"医疗卫生三名工程"项目(SZSM202211036) （SZSM202211036）
深圳市科技计划项目(多方合作项目)可持续发展专项(KCXFZ20200201101050887) （多方合作项目）
深圳市科技计划项目(无偿资助)市重点实验室组建(ZDSYS20190902092855097) （无偿资助）
2025耀动神州-药学科研能力建设基金项目(Z04J2025E170) （Z04J2025E170）
