新京报讯（记者王卡拉）1月6日，全球首个且目前唯一在中国获批治疗HER2突变晚期非小细胞肺癌的 口服靶向药物宗艾替尼片（商品名：圣赫途）正式装车发往全国，并陆续在全国多地药房上架，患者可 持医生处方在宗艾替尼的定点药房完成购药。 宗艾替尼于2025年8月在中国获批，用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系 统治疗的不可切除的局部晚期或转移性非小细胞肺癌成人患者。此次商业到货意味着该创新疗法正式惠 及临床，为HER2突变肺癌患者带来全新的治疗选择和希望。 肺癌是中国发病率和死亡率最高的恶性肿瘤之一。据统计，2022年我国新发肺癌病例超过106万例，非 小细胞肺癌占比约80%至85%。其中，HER2突变患者的比例约4%。 同济大学附属东方医院周彩存教授表示，过去，HER2突变非小细胞肺癌患者的治疗情况十分不理想， 生命质量无法得到保证。宗艾替尼的出现切实改善了患者的治疗结局与预后，使患者有望回归正常生 活。近期公布的数据显示，宗艾替尼在初治和脑转移患者中同样展现了令人鼓舞的治疗效果，我们非常 期待宗艾替尼在晚期NSCLC一线治疗中的突破，为更多患者带来希望。 作为"全球首创"的突破性疗法， ...

Core Insights - The approval of Zongertinib (圣赫途) by the National Medical Products Administration of China marks a significant advancement in the treatment of HER2-mutated non-small cell lung cancer (NSCLC) [1][2] - Zongertinib is the first and only oral HER2 tyrosine kinase inhibitor approved globally, providing a new treatment option for patients with advanced NSCLC who have previously received systemic therapy [1] Company Developments - Boehringer Ingelheim and China National Pharmaceutical Group (China Biopharmaceutical) announced their collaboration to promote Zongertinib in mainland China [1] - The drug's conditional approval is based on positive results from the Beamion-LUNG1 study, which demonstrated an objective response rate (ORR) of 71% and a disease control rate (DCR) of 96% among treated patients [1] - The median duration of response (DoR) was reported at 14.1 months, and the median progression-free survival (PFS) was 12.4 months, indicating strong efficacy [1] Industry Impact - The approval of Zongertinib addresses a critical challenge in NSCLC treatment, as there has been a lack of effective oral medications targeting HER2 with good tolerability [2] - The introduction of this innovative drug is expected to set a new benchmark for treating patients with HER2-mutated advanced NSCLC, significantly improving treatment options for a patient group with poor prognosis [2] - The drug's design allows for high selectivity, minimizing severe adverse reactions commonly associated with traditional treatments, thus enhancing patient quality of life [2]