On August 20, Sino Biopharmaceutical (01177) announced that its selective HER2 tyrosine kinase inhibitor, Zonectinib, has again received Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (CFDA). Zonectinib is indicated for the first-line treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring activating mutations in the HER2 tyrosine kinase domain (TKD). This Breakthrough Therapy designation was based on data from the BeamionLUNG-1 clinical trial.
Studies have shown that the 5-year survival rate of patients with advanced non-small cell lung cancer is less than 30%. Among them, about 2%-4% of non-small cell lung cancer is driven by HER2 gene mutations. Currently, the first-line treatment for patients with advanced HER2 mutation NSCLC is still chemotherapy ± immunotherapy.No new drugs have been officially approved in China. Zonectinib, a covalently bound, oral, selective HER2 small molecule inhibitor developed by Boehringer Ingelheim, has a well-tolerated and safe profile. In August of this year, Zonectinib received accelerated approval from the U.S. Food and Drug Administration (FDA).
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