Bayer's first-in-class oral HER2 inhibitor, sevabertinib, has been recommended for priority review by China's Centre for Drug Evaluation (CDE) for the first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) harbouring HER2 (ERBB2) activating mutations. The drug, which gained US approval in November 2025 for a later-line indication, is a non-covalent, reversible tyrosine kinase inhibitor (TKI) designed to target both EGFR and HER2 mutations, including HER2 exon 20 insertions.

The CDE recommendation is supported by data from the Phase I/II SOHO-01 study. In treatment-naive patients, sevabertinib demonstrated an objective response rate (ORR) of 71% and a median duration of response (mDOR) of 11.0 months. In a separate cohort of patients who had received prior systemic therapy, including HER2-targeted agents, the ORR was 38%. Bayer had previously submitted a new drug application (NDA) in China in July 2025 for the second-line treatment of the same patient population.

PharmCube's NextBiopharm® database shows that sevabertinib is under global development in nine other oncology indications. Click here to request a free trial for NextBiopharm®.