Zhi Tong Cai Jing·2025-08-20 14:11Group 1 - China National Pharmaceutical Group announced that the selective HER2 tyrosine kinase inhibitor "Zongaitini" has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 tyrosine kinase domain (TKD) activating mutations [1] - The breakthrough therapy designation is based on data from the Beamion LUNG-1 clinical trial, which is a Phase Ia/Ib open-label trial assessing the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of Zongaitini in patients with HER2-mutant solid tumors [1] - The five-year survival rate for advanced non-small cell lung cancer patients is less than 30%, with approximately 2-4% of NSCLC driven by HER2 gene mutations, indicating a significant unmet medical need for targeted therapies in this patient population [1] Group 2 - Zongaitini is a covalent, orally administered selective HER2 small molecule inhibitor developed by Boehringer Ingelheim, which covalently binds to both wild-type and mutant HER2 receptors while preserving wild-type EGFR signaling, ensuring efficacy along with good tolerability and safety [2] - Zongaitini has previously received priority review and breakthrough therapy designation from CDE for the indication of previously treated patients with advanced HER2-mutant NSCLC, and it received accelerated approval from the U.S. Food and Drug Administration (FDA) in August [2]