Bayer confirms China approval of sevabertinib after prior treatment and is studying first-line use
Key Facts
Bayer said China approved sevabertinib as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer whose tumors carry activating HER2 mutations and who have received prior systemic therapy. The approval therefore covers previously treated patients and does not include first-line use. Separately, China granted the drug breakthrough therapy designation to accelerate its development for first-line use in patients with advanced HER2-mutant lung cancer. Bayer said the designation is intended to accelerate development, while a Phase III trial continues to evaluate the drug for this use. On January 6, 2026, the company announced that China’s Center for Drug Evaluation and the U.S. Food and Drug Administration had granted the drug potential breakthrough therapy designation as a first-line treatment.
The Chinese registration application is based on positive results from the SOHO-01 trial, an ongoing Phase I/II study in previously treated patients with advanced HER2-mutant lung cancer. The possibility of using the drug before prior systemic treatment is being studied in the Phase III SOHO-02 trial in China. Bayer said the study is evaluating sevabertinib as a first-line treatment option for these patients. The different development stages indicate that the existing approval and ongoing evaluation concern different lines of treatment. The company did not describe the breakthrough therapy designation as marketing approval for first-line use.
In the United States, the Food and Drug Administration on September 9, 2026, granted accelerated approval to sevabertinib for adults with locally advanced or metastatic non-squamous non-small cell lung cancer with activating HER2 tyrosine kinase domain mutations, as identified by an FDA-approved test. The U.S. approval applies to a defined patient group based on tumor type, mutation and test. Bayer described the drug as a small-molecule, reversible oral tyrosine kinase inhibitor targeting HER2 mutations. This places the drug among targeted therapies directed at a specific genetic alteration in the tumor. The SOHO-02 trial remains central to evaluating its first-line use in China.
In China’s market, the RatingDog services activity index fell to 50.8 points in October from 51.6 points in September, but remained above the 50-point threshold separating expansion from contraction. October’s reading was the weakest since July, reflecting slower growth in the sector. By contrast, new export orders rose for a sixth consecutive month, the longest such growth streak since 2024. Services companies, however, cut average selling prices for a second month, while input prices rose at their fastest pace in five months. Companies attributed the increase in input costs to higher material, fuel and wage prices.
Services companies’ confidence fell to its lowest level since July, with firms citing concerns about rising input prices and intensifying competition. In trading, Bayer’s U.S.-listed shares, under the ticker BAYRY, closed at $14.41 on November 3, 2026, up from $13.95 in the previous session. Closing data show an increase between the two sessions, without identifying the reason for the move. The drug’s main regulatory development in China remains approval for patients who have received prior treatment, while first-line use is being studied in a Phase III trial. The information provided did not specify when results from that study or a Chinese decision on this use are expected.