China's National Medical Products Administration (NMPA) has granted conditional approval to Boehringer Ingelheim's Hernexeos (zongertinib tablets), for use as a single agent in adults with non-small cell lung cancer (NSCLC) that is unresectable, locally advanced or metastatic.
The approval is specifically for those whose tumours exhibit activating mutations in the human epidermal growth factor receptor 2 (HER2) gene (ERBB2) and who have previously undergone a minimum of one systemic therapy.
The decision by the NMPA was informed by the outcomes of the Phase Ib Beamion-LUNG 1 study, which revealed a notable objective response rate of 71% in a cohort of 75 participants.
Within this group, 7% experienced a complete response, and 96% reported disease control.
The median duration of response stood at 14.1 months, while the median progression-free survival reached 12.4 months.
The therapy has also been acknowledged by China's Center for Drug Evaluation with a breakthrough therapy designation for its potential as a first-line treatment for adults with unresectable or metastatic NSCLC that carry activating mutations in the HER2 tyrosine kinase domain.
Zongertinib operates as an irreversible tyrosine kinase inhibitor that specifically targets HER2 mutations while sparing wild-type epidermal growth factor receptor, which is expected to reduce toxicity.
This targeted therapy, which is administered orally, has been approved by the US Food and Drug Administration and China's NMPA and gained orphan drug status in Japan.
Boehringer Ingelheim board of managing directors chairman Shashank Deshpande stated: “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.”
In July 2025, Re-Vana Therapeutics, a spin-out from Queen’s University, partnered with Boehringer to develop ophthalmic therapies under a licensing agreement.
