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， ...

Group 1 - China National Medical Products Administration has approved the listing of Zongaitini tablets (brand name: Shenghetu) for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy [1] - Shenghetu is the world's first and currently the only approved oral HER2 tyrosine kinase inhibitor, receiving conditional approval in China based on positive results from the Beamion-LUNG1 study, which evaluated the efficacy and safety of Zongaitini in patients with advanced NSCLC with HER2 (ERBB2) mutations [1] - In the treated cohort of previously treated patients (N=75), the objective response rate (ORR) reached 71% (95% CI: 60-80), with 7% achieving complete response, and the disease control rate (DCR) was as high as 96% [1] Group 2 - Lung cancer remains the leading cancer type globally and in China, with significant unmet clinical needs [2] - The approval of Shenghetu in China will provide a more effective and compliant treatment option for many HER2-mutated non-small cell lung cancer patients, further enriching the company's product line in the oncology field [2] - The company aims to bring therapeutic benefits to more patients with the motto "Health technology, warming more lives" [2]