Bayer has received marketing authorisation in China for sevabertinib (BAY 2927088) for the treatment of adults with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring HER2 (ERBB2)-activating mutations who have received prior systemic therapy. Sevabertinib is an oral, non-covalent, reversible tyrosine kinase inhibitor (TKI) designed to target both EGFR and HER2 mutations, including HER2 exon 20 insertions. The drug was previously approved in the US market in 2025 for a similar patient population.

The approval is supported by data from the I/II stage SOHO-01 study, which showed an objective response rate (ORR) of 64% and a median progression-free survival (PFS) of 8.3 months in previously treated, HER2 inhibitor-naive patients. The drug also demonstrated activity in patients who had received prior HER2-targeted therapies, including antibody-drug conjugates (ADCs). Bayer has also submitted a new drug application (NDA) in China for the first-line treatment of HER2-mutant NSCLC, with a decision expected following a recent priority review recommendation.

PharmCube's NextBiopharm® database shows sevabertinib is under clinical devleopment in China for eight other oncology indications. Click here to request a free trial for NextBiopharm®.