The accelerated approval followed a Breakthrough Therapy Designation and Priority Review status, reflecting the high recognition of its clinical benefit.
"The absence of a well-tolerated oral drug targeting HER2, has been a long-standing challenge in the treatment of non-small cell lung cancer. The approval of zongertinib will change this landscape, setting a new treatment benchmark for HER2-mutant advanced non-small cell lung cancer,” said Professor Wu Yilong from Guangdong Provincial People's Hospital, Chairman of the Chinese Thoracic Oncology Group (CTONG). “This innovative drug provides a highly effective, targeted, oral treatment option for this patient population, which has an extremely poor prognosis and very limited treatment choices."
The conditional approval has been granted based on data from the Phase Ib Beamion-LUNG 1 trial, which demonstrated an objective response rate (ORR) of 71% (N=75). Data showed 7% of patients had a complete response (CR), with almost all patients (96%) achieving disease control. The median duration of response (mDoR) was 14.1 months, and the median progression-free survival (PFS) was 12.4 months. These results were previously presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine.
HERNEXEOS demonstrated a manageable safety profile with a low discontinuation rate of 2.9%.
The therapy was recently granted Breakthrough Therapy Designation by China’s Center for Drug Evaluation (CDE) for the first-line treatment of adult patients with unresectable or metastatic NSCLC harboring activating mutations in the HER2 tyrosine kinase domain (TKD). Zongertinib is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby limiting associated toxicities.
“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,” said Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim. “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 tumor-agnostic setting.”
Lung cancer is the leading cause of cancer death in China and the incidence and mortality rates of lung cancer have significantly increased in recent years. NSCLC is the most common type of lung cancer, accounting for approximately 85% of all cases. HER2 mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases. Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.
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