India Pharma Outlook Team | Wednesday, 03 September 2025
The National Medical Products Administration (NMPA) of China has authorized Boehringer Ingelheim's Hernexeos (zongertinib tablets) as a monotherapy for the treatment of adult patients with non-small cell lung cancer (NSCLC) that is incurable, locally advanced, or metastatic and whose tumors contain activating HER2 (ERBB2) mutations.
These patients have already received at least one line of systemic therapy. Its clinical advantage was highly recognized, as seen by its rapid approval after receiving a Breakthrough Therapy Designation and Priority Review designation.
"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."
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Data from the phase Ib Beamion-LUNG 1 study, which showed an objective response rate (ORR) of 71% (N=75), served as the basis for the conditional approval. According to the data, nearly all patients (96%) achieved illness control, while 7% of patients experienced a complete response (CR).
The median progression-free survival (PFS) was 12.4 months, while the median duration of response (mDoR) was 14.1 months. These findings were concurrently published in The New England Journal of Medicine and previously presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR).
