Boehringer’s HERNEXEOS Approved in China as First Oral Targeted Therapy for HER2-Mutant Advanced NSCLC

Boehringer Ingelheim announced that its drug HERNEXEOS (zongertinib tablets) has received approval from China’s National Medical Products Administration (NMPA) as a monotherapy treatment for adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations, who have previously undergone at least one systemic therapy.

The accelerated approval, granted after the drug received Breakthrough Therapy Designation and Priority Review status, underscores the significant clinical benefits HERNEXEOS offers for this patient population, which has had limited treatment options.

Professor Wu Yilong of Guangdong Provincial People’s Hospital and Chairman of the Chinese Thoracic Oncology Group (CTONG) hailed the approval as a transformative milestone. He emphasized that until now, there was no well-tolerated oral HER2-targeted drug for NSCLC, making HERNEXEOS a new benchmark in treating HER2-mutant advanced NSCLC.

The approval was based on data from the Phase Ib Beamion-LUNG 1 trial, where HERNEXEOS demonstrated a 71% objective response rate (ORR) among 75 patients, including 7% achieving complete response. Nearly all patients (96%) experienced disease control, with a median duration of response of 14.1 months and median progression-free survival of 12.4 months. These promising results were shared at the American Association for Cancer Research (AACR) Annual Meeting 2025 and published in The New England Journal of Medicine.

HERNEXEOS also showed a manageable safety profile, with a low discontinuation rate of 2.9%, highlighting its tolerability for patients.

This approval marks a significant advancement for targeted oral therapies in HER2-mutant NSCLC in China.