By Fineline Cube 
On August 20, 2025, Sino Biopharmaceutical Limited (HKG: 1177) announced that its selective HER2 tyrosine kinase inhibitor (TKI), zongertinib, has been granted a second Breakthrough Therapy Designation by China’s Center for Drug Evaluation (CDE) for the first-line treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations.
Mechanism of Zongertinib
Zongertinib, co-developed by Boehringer Ingelheim and Sino Biopharmaceutical, is a covalent-binding, oral, selective HER2 small-molecule inhibitor. It covalently binds to both wild-type and mutant HER2 receptors while preserving wild-type EGFR signaling, ensuring good efficacy with favorable tolerability and safety.
Collaboration and Development Background
The drug was developed through a collaboration between Boehringer Ingelheim and Sino Biopharmaceutical. This partnership has been instrumental in advancing zongertinib’s development and securing multiple regulatory milestones.
Earlier Achievements and FDA Approval
Previously, zongertinib received Priority Review and Breakthrough Therapy Designation from the CDE for advanced HER2-mutated NSCLC in previously treated patients. In a significant milestone, the U.S. FDA granted zongertinib accelerated approval in August of this year, further underscoring its potential in the treatment of NSCLC.-Fineline Info & Tech