Boehringer Ingelheim has received conditional approval from China’s National Medical Products Administration (NMPA) for Hernexeos (zongertinib tablets) to treat adults with HER2-mutant advanced non-small cell lung cancer (NSCLC).
Zongertinib is an irreversible tyrosine kinase inhibitor (TKI) that selectively targets HER2 mutations while avoiding wild-type EGFR to reduce associated toxicities.
The drug is indicated for adults with unresectable, locally advanced, or metastatic NSCLC with activating HER2 mutations, after at least one line of prior therapy.
The NMPA approval follows its Breakthrough Therapy Designation and Priority Review status granted by China’s Centre for Drug Evaluation (CDE).
According to Boehringer Ingelheim, Hernexeos is the first oral targeted therapy for patients with previously treated HER2-mutant advanced NSCLC.
Boehringer Ingelheim managing directors board chairman Shashank Deshpande said: “It is encouraging to see the NMPA’s continued recognition of zongertinib’s potential.
“Breakthrough Therapy Designation for first-line use of zongertinib in China illustrates the urgent need in this patient population. It is a critical next step to making this therapy available to more patients in need.
“Given the robust clinical evidence, regulatory approvals and breakthrough designation, we are confident that zongertinib has the potential to redefine the standard for treating HER2-driven cancers.
“Therefore, we have initiated clinical studies to evaluate this therapy in other cancers, including breast cancer and the tumour-agnostic setting.”
The NMPA approval is based on results from the Phase 1b Beamion-LUNG 1 trial, which showed a 71% objective response rate.
The study involved 75 patients and showed a complete response in 7% of cases, with a disease control rate of 96%.
The median duration of response was 14.1 months, and progression-free survival stood at 12.4 months.
In addition to its approval in China, Hernexeos also received the US Food and Drug Administration (FDA) approval and Orphan Drug Designation in Japan.
