Core Viewpoint - China National Medical Products Administration has approved the listing of Zongaitini tablets (brand name: Shenghetu®) for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have received at least one prior systemic therapy [1] Group 1: Product Approval - Zongaitini tablets are the first and currently the only approved oral HER2 tyrosine kinase inhibitor globally [1] - The conditional approval in China is based on positive results from the Beamion-LUNG1 study, which evaluated the efficacy and safety of Zongaitini in patients with advanced NSCLC harboring HER2 (ERBB2) mutations [1] Group 2: Clinical Data - 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 [1] - The disease control rate (DCR) was as high as 96%, with a median duration of response (DoR) of 14.1 months and a median progression-free survival (PFS) of 12.4 months [1] - The safety profile of Zongaitini is manageable, with a treatment interruption rate of only 2.9% during the study [1] Group 3: Future Research - Additional research data for TQC3721 (PDE3/4 inhibitor), TQC2731 (TSLP monoclonal antibody), and TQC3403 (Umeclidinium/Vilanterol inhalation powder) will be presented at the ERS 2025 conference [2]