宗艾替尼在华获批，用于非小细胞肺癌治疗

Core Viewpoint - The conditional approval of Zongaitin tablets by the National Medical Products Administration marks a significant advancement in the treatment of HER2-mutated, unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients who have previously received at least one systemic therapy [1][2]. Group 1: Drug Approval and Market Impact - Zongaitin tablets are the first and only oral HER2 tyrosine kinase inhibitor approved globally, previously recognized with "breakthrough therapy designation" and "priority review" in China [2]. - The approval is based on positive results from the Beamion-LUNG1 study, which demonstrated an objective response rate (ORR) of 71% in treated patients, with a complete response rate of 7% and a disease control rate (DCR) of 96% [2]. - The median duration of response (DoR) was 14.1 months, and the median progression-free survival (PFS) was 12.4 months, indicating promising efficacy [2]. Group 2: Clinical Significance and Patient Impact - The approval of Zongaitin addresses a critical challenge in NSCLC treatment, providing a targeted oral medication for HER2 mutations, which previously lacked effective options [3]. - This innovative drug offers a high-efficiency, targeted treatment alternative for a patient group with poor prognosis and limited treatment choices [3]. - Zongaitin's selective design helps avoid severe skin or gastrointestinal adverse reactions associated with traditional treatments, thereby improving patient tolerance and quality of life [3].