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]

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]