SINO BIOPHARM (01177) announced that its selective HER2 tyrosine kinase inhibitor (TKI) "Zongaitinib" has once again received breakthrough therapy designation from China's Center for Drug Evaluation (CDE) of the National Medical Products Administration. The designation is 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.

This breakthrough therapy designation is based on data from the Beamion LUNG-1 clinical trial, a Phase Ia/Ib first-in-human open-label study designed to determine the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of Zongaitinib in patients with HER2-mutated solid tumors (NCT04886804). Updated data will be presented later this year.

Research shows that the 5-year survival rate for patients with advanced non-small cell lung cancer is less than 30%. Among these cases, approximately 2-4% of NSCLC are driven by HER2 gene mutations. Currently, first-line treatment for patients with advanced HER2-mutated NSCLC remains primarily chemotherapy with or without immunotherapy, with no novel targeted drugs formally approved in China. Due to the lack of targeted therapies, these patients typically experience poor treatment outcomes and endure both physical and psychological burdens.

Zongaitinib is a covalent, oral selective HER2 small molecule inhibitor developed by Boehringer Ingelheim. It covalently binds to both wild-type and mutant HER2 receptors while preserving wild-type EGFR signaling, ensuring efficacy while maintaining good tolerability and safety.

Previously, Zongaitinib had already been granted priority review and breakthrough therapy designation by the CDE for the treatment of patients with HER2-mutated advanced NSCLC who had received prior therapy. In August this year, Zongaitinib received accelerated approval from the U.S. Food and Drug Administration (FDA).