Group 1 - China National Medical Products Administration (NMPA) has granted breakthrough therapy designation to the selective HER2 tyrosine kinase inhibitor, Zongaitini, for first-line treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain (TKD) activating mutations [1] - The breakthrough designation is based on data from the Beamion LUNG-1 clinical trial, which is an open-label Phase Ia/Ib 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 NSCLC 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, developed by Boehringer Ingelheim, is a covalent, oral selective HER2 small molecule inhibitor that 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 the NMPA for the indication of previously treated patients with advanced HER2-mutant NSCLC, and it has also received accelerated approval from the U.S. Food and Drug Administration (FDA) [2] - Boehringer Ingelheim has established a strategic partnership with the group to bring innovative oncology therapies to the mainland China market, leveraging both parties' complementary strengths to provide better treatment options for cancer patients [2]