【摘要】 本文整理了2025年国家药品监督管理局批准上市的33种实体瘤新药，收集详细信息并汇总分析。统计结果显示，近半数新药针对难治性分子亚型，包括EGFR外显子20插入突变、HER-2激活突变、KRAS G12C变异、NTRK基因融合等。当前治疗方案后线选择有限，这一研发方向与临床需求相契合。本研究结合公开审评资料和Ⅲ期临床试验公开数据，探讨了这些创新药物的作用机制，梳理了现有循证医学证据，分析了其进入临床应用的潜力，适用病症覆盖多个癌种，如肺癌、乳腺癌、消化系统肿瘤、泌尿系统肿瘤，还包括多种罕见实体瘤。这些新药在疗效上取得了一定进展，多个癌种后线治疗客观缓解率从不足20%提升至40%以上，但部分药物的安全性数据仍需通过真实世界长期观测。从临床角度看，它们为既往难以获得更好治疗的患者提供了更多可行方案，但核心挑战在于，需在分子检测、循证证据强度与患者个体特征间建立精准关联。分子检测的普及、医保覆盖及真实世界观察是影响这些药物广泛应用于临床的关键因素。更多还原

【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.更多还原