Group 1 - The core point of the article is the approval of the oral HER2 tyrosine kinase inhibitor, Saint Heru (Zong Aitini), for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 activation mutations in mainland China [1] - Saint Heru is the first and currently the only approved oral HER2 tyrosine kinase inhibitor in the industry, addressing a significant unmet medical need in lung cancer treatment [1] - The approval reflects the high recognition of the clinical value of this innovative drug by the National Medical Products Administration, as it received "breakthrough therapy designation" and "priority review" status, leading to accelerated approval [1] Group 2 - The strategic partnership between Boehringer Ingelheim and China National Pharmaceutical Group aims to bring innovative oncology therapies to the mainland Chinese market [2] - The collaboration will focus on multiple innovative oncology products from Boehringer Ingelheim that are in late-stage clinical development, enhancing the treatment options available for cancer patients in China [2]

8月29日，勃林格殷格翰与中国生物制药(01177.HK)共同宣布，双方在中国大陆联合推广的圣赫途(中文 通用名：宗艾替尼片，英文通用名：zongertinib)获得中国国家药品监督管理局正式批准，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 (NSCLC)成人患者。 圣赫途是全球首个且目前唯一获批的口服HER2酪氨酸激酶抑制剂，此次在华获得附条件批准是基于 Beamion-LUNG1研究的积极结果，该试验评估了宗艾替尼在HER2(ERBB2)突变晚期非小细胞肺癌 (NSCLC)患者中的疗效和安全性。数据显示，在接受治疗的队列1经治患者(N=75)中，客观缓解率 (ORR)达71%(95%CI：60-80)，其中7%为完全缓解，疾病控制率(DCR)高达96%。中位缓解持续时间 (DoR)达14.1个月，中位无进展生存期(PFS)达12.4个月。该数据已在2025年美国癌症研究协会(AACR)年 会上公布，并同步刊发于《新英格兰医学杂志》。此外，宗艾替尼的安全性可控，研究中治疗中断率仅 2.9%。 中国胸部肿瘤研究协作组(CTONG)主席、广东 ...