Bayer Wins China Approval for Sevabertinib After 75% Response Rate

Bayer has secured first-line marketing authorization for sevabertinib in China for adults with unresectable, locally advanced or metastatic HER2-mutant non-small cell lung cancer (NSCLC). The approval, supported by a 75% objective response rate (ORR) in the Phase I/II SOHO-01 trial, expands access to targeted treatment for a patient population with historically limited therapeutic options.

NMPA Approves First-Line Use Based on SOHO-01 Results

China’s National Medical Products Administration (NMPA) has approved Bayer’s sevabertinib (Hyrnuo) as a first-line treatment for adults with unresectable, locally advanced or metastatic NSCLC harbouring activating HER2 (ERBB2) mutations.

The authorization is based on efficacy and safety findings from the treatment-naïve cohort of the ongoing Phase I/II SOHO-01 trial (NCT05099172), which evaluated sevabertinib in patients with advanced HER2-mutant NSCLC.

Among 73 treatment-naïve patients, sevabertinib demonstrated an ORR of 75%, including complete responses in 6% and partial responses in 70%. Notably, 73% of responders maintained their responses for at least six months, indicating sustained tumour control in a substantial proportion of patients.

The safety profile remained consistent with previously reported findings. However, the approval relies on response-based endpoints, and confirmation of clinical benefit remains necessary.

HER2-Targeted Inhibition Addresses an Unmet Need in NSCLC

HER2-activating mutations occur in approximately 2% to 4% of patients with advanced NSCLC and represent a distinct molecular subtype associated with limited treatment options and historically poor outcomes.

Sevabertinib is an oral, reversible, small-molecule tyrosine kinase inhibitor (TKI) that selectively targets mutant HER2, including exon 20 insertions and HER2 point mutations. By inhibiting aberrant HER2 signalling, the drug interferes with molecular pathways involved in cancer cell growth and survival.

Unlike irreversible inhibitors, reversible TKIs temporarily bind their molecular targets. This pharmacological distinction provides a different approach to HER2 inhibition, although comparative clinical evidence is needed to establish differences in efficacy and tolerability.

Phase III SOHO-02 to Confirm Clinical Benefit

Bayer’s confirmatory Phase III SOHO-02 trial (NCT06452277) is evaluating sevabertinib against standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC.

The study will provide additional evidence on whether the response rates observed in SOHO-01 translate into sustained clinical benefit compared with existing treatment approaches. Continued approval in China may be contingent upon verification and description of clinical benefit through this confirmatory trial.

The company is also investigating sevabertinib in the panSOHO study (NCT06760819), which is evaluating patients with metastatic or unresectable solid tumours harbouring HER2-activating mutations, excluding advanced NSCLC.

Regulatory Expansion Across Major Markets

The China approval adds to sevabertinib’s expanding regulatory presence. In September 2026, the US Food and Drug Administration (FDA) granted accelerated approval for first-line treatment of advanced HER2-mutant NSCLC. Japan’s Ministry of Health, Labour and Welfare also approved the therapy in August 2026 for this indication.

China had previously approved sevabertinib for patients with advanced HER2-mutant NSCLC following one prior systemic therapy. The Center for Drug Evaluation (CDE) subsequently granted Breakthrough Therapy Designation to accelerate its development in the first-line setting.

Commenting on the latest milestone, Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, highlighted the importance of expanding precision oncology options for patients in China, particularly those with molecularly defined NSCLC.

The first-line approval strengthens Bayer’s position in HER2-targeted lung cancer treatment. However, the longer-term clinical value of sevabertinib will depend on confirmatory Phase III evidence and its ability to establish meaningful benefits over existing treatment strategies.

 Reference

Sevabertinib approved in China as first-line treatment for patients with HER2-mutant non-small cell lung cancer, Bayer, 04 November 2026

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/​or Human Epidermal Growth Factor Receptor 2 (HER2), ClinicalTrials.gov ID NCT05099172