Boehringer Ingelheim’s HERNEXEOS (zongertinib tablets) has secured conditional approval from China’s National Medical Products Administration (NMPA), marking a major step forward in the first-line treatment of a difficult-to-treat form of lung cancer.
The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors carry activating HER2 (ERBB2) tyrosine kinase domain mutations. Full approval will depend on confirmation of clinical benefit in an ongoing trial.
The approval is backed by strong early clinical data showing a 75.7% objective response rate in treatment-naïve patients, positioning HERNEXEOS as a potentially transformative option in a setting where treatment choices have historically been limited.
The therapy had previously received Breakthrough Therapy Designation from China’s Center for Drug Evaluation (CDE), underscoring its priority status.
“In the past, patients with HER2-mutant advanced non-small cell lung cancer faced significant diagnostic and treatment challenges in clinical practice.
"These challenges not only placed considerable physical and psychological burdens on patients but also limited the delivery of precise lung cancer treatment,” said Professor Yi-Long Wu from Guangdong Provincial People's Hospital, Chairman of the Chinese Thoracic Oncology Group (CTONG).
“This advancement directly addresses patients’ core clinical needs for quality care."
The approval draws on data from 74 previously untreated patients in the Phase Ib Beamion LUNG-1 trial. Results showed an objective response rate of 75.7%, including 10.8% complete responses and 64.9% partial responses. Median duration of response reached 15.2 months, with most treatment-related side effects reported as low-grade.
Across a broader safety population of 177 patients, adverse events led to dose reductions in 9% of cases and discontinuation in 6%.
“The first-line approval of HERNEXEOS in China marks an important step forward in our ambition to redefine the treatment of HER2-driven cancers,” said Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim.
“Building on strong global momentum, including approvals in the U.S., and supported by compelling clinical evidence, we are advancing this therapy across various stages of disease and tumor types. This milestone reflects not only the progress we have made, but the broader opportunity ahead – to deliver unprecedented impact for people living with cancer, now and for generations to come.”
Lung cancer remains the world’s deadliest cancer, with NSCLC accounting for the majority of cases. Up to 4% are driven by HER2 mutations, which fuel uncontrolled tumor growth and disease progression.
