Bayer’s sevabertinib approved in China as first‑line therapy for HER2‑mutant NSCLC

Regulatory approval in China

The National Medical Products Administration (NMPA) granted marketing authorization for sevabertinib as a first‑line therapy for adult patients with unresectable, locally advanced or metastatic non‑small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) activating mutations.

Clinical evidence

The approval was based on objective response rate (ORR) and duration of response (DOR) from a treatment‑naïve cohort (N=73) in the ongoing Phase I/II SOHO‑01 trial (NCT05099172). The cohort achieved an ORR of 75%, including complete responses in 6% and partial responses in 70%; 73% of responders maintained their response for at least six months. The safety profile was reported as consistent with previous findings.

Ongoing development and international status

Continued approval in China may be contingent on verification of clinical benefit in the Phase III SOHO‑02 confirmatory trial (NCT06452277), which compares sevabertinib with standard of care in treatment‑naïve advanced HER2‑mutant NSCLC. Sevabertinib previously received NMPA approval earlier this year for patients after one prior systemic therapy and Breakthrough Therapy Designation from China’s CDE for first‑line use. The U.S. FDA granted accelerated first‑line approval in September 2026 following Priority Review and Breakthrough designation, and Japan’s Ministry of Health, Labor and Welfare approved sevabertinib in August for use regardless of line of therapy.

Drug profile

Sevabertinib (Hyrnuo) is an oral, reversible small‑molecule tyrosine kinase inhibitor that targets mutant HER2, including exon 20 insertions and point mutations. It was developed from a strategic research alliance between Bayer and the Broad Institute.