Boehringer-Ingelheim and Sino Biopharmaceutical’s Zongertinib approved for first-line indication
On May 21, Boehringer-Ingelheim announced that a new indication for its lung cancer drug Zongertinib has been officially approved for use as a first-line monotherapy in adult patients with advanced non-small cell lung cancer harboring HER2 tyrosine kinase domain-activating mutations. This indication had previously been granted priority review status.
Zongertinib is a highly selective, irreversible HER2-TKI that precisely targets and inhibits HER2 without affecting wild-type EGFR, effectively reducing drug-related toxicity. In April 2024, Sino Biopharmaceutical entered into a collaboration with Boehringer-Ingelheim to jointly advance the drug’s development and commercialization in China. The regulatory review process proceeded efficiently and smoothly: in August 2025, Zongertinib achieved simultaneous approvals in China and the United States for the treatment of HER2-mutant lung cancer in the post-line setting, becoming the world’s first oral targeted therapy of its kind. In February 2026, its first-line indication received FDA approval in the U.S., and now it has successfully obtained approval in China, enabling rapid synchronized approvals both domestically and internationally.This approval is based on data from the Beamion LUNG-1 study, with results presented at the 2026 ELCC Congress and simultaneously published in the New England Journal of Medicine. Clinical data show that among 74 treatment-naïve patients, the objective response rate reaches 76%, with a complete response rate of 11% and a partial response rate of 65%; the median duration of response is 15.2 months, and the median progression-free survival is 14.4 months. The safety profile is favorable, with most adverse events being mild; only 16% of patients require dose reduction, and 9% discontinue treatment.
