Bayer closes the gap with Boehringer in China’s lung cancer race

Bayer has received another approval in China for its HER2 inhibitor sevabertinib. The National Medical Products Administration (NMPA) has authorized its use in adults with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor activating HER2 mutations. What is new is primarily the line of therapy: Sevabertinib can now also be used in previously untreated patients.

Why it matter: This is not the drug’s first approval. Sevabertinib, marketed by Bayer under the brand name Hyrnuo, was approved in the U.S. in 2025 for previously treated patients. A corresponding approval in China followed in early 2026 for patients who had received prior systemic therapy. The first-line approval in China therefore represents an indication expansion. In the U.S., the FDA had already granted accelerated approval for first-line treatment in September 2026, while Japan had authorized the drug for this patient population in August.

By the numbers: China’s first-line approval is based on data from the ongoing Phase 1/2 SOHO-01 trial. In a cohort of 73 previously untreated patients, the objective response rate was 75%. Six percent achieved a complete response, while another 70% showed a partial response. Among patients who responded, 73% maintained their response for at least six months.

These are impressive early signs of activity. However, they do not yet establish whether the treatment extends progression-free or overall survival compared with the current standard of care. The approval may therefore remain conditional on confirmation of clinical benefit. That is precisely what the ongoing Phase 3 SOHO-02 trial is intended to demonstrate: It compares sevabertinib with standard therapy in previously untreated patients with advanced HER2-mutated NSCLC.

China’s strategy: The fact that conditional first-line approval has nevertheless been granted on the basis of these data illustrates China’s strategy of making improvements observed in clinical trials directly available to the broader patient population. This is not without risk, as further studies could also reveal negative or, at best, neutral efficacy signals. Yet the high response rate has evidently been sufficient for regulators to allow the drug to be used beyond the clinical trial setting.

For Bayer and other companies, this is also highly attractive because it allows them to avoid the difficulties associated with studying previously treated patients in clinical trials. In these patients, analyzing response and efficacy data is often particularly challenging because, for example, their immune systems may be weakened or other effects of prior treatment may interfere with the investigational drug.

Boehringer Ingelheim has a head start: The competition is already underway. Boehringer Ingelheim has another oral HER2-targeted tyrosine kinase inhibitor in its portfolio: zongertinib (Hernexeos). The drug was initially approved in China for previously treated patients and received authorization for first-line treatment in May 2026. Zongertinib therefore reached the first-line setting in China ahead of sevabertinib.

Clinically, the two drugs are also serious competitors. Response rates of around 76% have been reported for zongertinib in a first-line cohort of the Beamion LUNG-1 trial. These figures are therefore similar to the 75% reported in Bayer’s SOHO-01 trial. However, a direct comparison would not be scientifically sound: The data come from different studies, patient populations and follow-up periods. The adverse-event profiles and duration of response must also be considered in their respective clinical contexts.

Alongside the two oral drugs, trastuzumab deruxtecan (Enhertu), developed by AstraZeneca and Daiichi Sankyo, also plays an important role. The antibody-drug conjugate (ADC) also targets HER2 but works through a different mechanism than the small molecules developed by Bayer and Boehringer. In HER2-mutated NSCLC, the ADC is primarily relevant as an option after prior treatment. It is also being evaluated in the first-line setting in a Phase 3 trial: DESTINY-Lung04 is comparing trastuzumab deruxtecan with standard treatment.

The three programs thus represent different development approaches: Sevabertinib and zongertinib are oral TKIs that block signaling by the mutated HER2 receptor. As an ADC, trastuzumab deruxtecan delivers a cytotoxic substance directly to HER2-expressing tumor cells. Which approach will prevail in which patient population and line of therapy remains an open question.

The big picture: HER2 mutations are found in approximately 2% to 4% of patients with advanced NSCLC. This makes the subgroup relatively small, but given the prevalence of lung cancer in China, it is also commercially relevant. Lung cancer is among the most common cancers in the country and a leading cause of cancer-related deaths. In addition, HER2-mutated lung cancer represents a distinct molecular subgroup for which targeted treatment options have so far been limited.

For Bayer, China is also more than just a large sales market. The approval demonstrates how important China’s drug regulator, the NMPA, has become for the global development and launch of innovative cancer medicines. The drug’s breakthrough therapy designation had already accelerated its development for first-line treatment. Approval based on response rate and duration of response allows earlier market access but requires subsequent confirmation of clinical benefit. For Bayer, this represents another step toward establishing sevabertinib internationally.

The drug originated from Bayer’s research alliance with the Broad Institute of MIT and Harvard University. This also supports Bayer’s strategy of combining external academic research with its own pharmaceutical development capabilities.

Bottom line: For Bayer, the Chinese approval represents an important regulatory and commercial step. In the competition with rival drugs, however, the decisive question will not simply be which treatment achieves the highest response rate in an early-stage trial. Other important factors include duration of response, progression-free and overall survival, tolerability, efficacy against brain metastases and which HER2 mutations actually respond to treatment.

Only the Phase 3 data from SOHO-02, Beamion LUNG-2 and DESTINY-Lung04 will allow a much clearer assessment of the competitive landscape. Until then, sevabertinib remains another promising contender in a field — HER2 — that is rapidly evolving from an area of unmet medical need into a genuine race for first-line treatment.