Recently, the official website of China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) indicated that Bayer has formally submitted a New Drug Application (NDA) for BAY 2927088 tablets, a Category 1 innovative drug. The application seeks approval for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have previously received systemic therapy. As a targeted therapy currently undergoing global accelerated development, BAY 2927088 has already received multiple breakthrough therapy designations from both Chinese and U.S. regulatory agencies and was granted Priority Review status by the U.S. FDA.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC accounting for over 85% of cases. Due to the lack of early symptoms, many patients are diagnosed at advanced stages when surgical options are no longer viable. While precision medicine has brought new treatment opportunities for some, HER2-mutant NSCLC continues to pose a significant therapeutic challenge. HER2 activating mutations are found in approximately 2%–4% of NSCLC patients. Based on the 2.48 million new global lung cancer cases reported in 2022, this translates to an estimated 50,000 to 100,000 new patients annually. These individuals typically face poor prognoses and a longstanding lack of approved targeted therapies, leaving a significant unmet medical need.

BAY 2927088, also known as Sevabertinib (structure shown in Formula I), is an oral, reversible tyrosine kinase inhibitor (TKI) designed specifically to target HER2 mutations. It effectively inhibits both HER2 exon 20 insertions and point mutations, while demonstrating selective inhibition of mutant EGFR over wild-type EGFR. This selectivity improves targeting precision and reduces the risk of off-target effects. The molecular design of Sevabertinib is supported by research collaborations with the Broad Institute of MIT and Harvard University.

Formula I

Sevabertinib is currently being evaluated in several ongoing clinical trials, including the global Phase III SOHO-02 study, which aims to assess its efficacy and safety as a first-line treatment in HER2-mutant NSCLC patients. Its potential in treating other solid tumors is also being explored in the panSOHO study.

The NDA in China is primarily supported by positive findings from the Phase 1/2 SOHO-01 trial, an open-label, multicenter study. The trial assessed two cohorts: Cohort D included patients who had not previously received HER2-targeted therapies, and Cohort E included those who had been treated with HER2-targeted antibody-drug conjugates (ADCs). In Cohort D, the objective response rate (ORR) was 70.5%, the disease control rate (DCR) reached 81.8%, and the median duration of response (mDOR) was 8.7 months. Notably, patients with the common HER2 YVMA insertion mutation achieved an ORR of 90%. In Cohort E, despite prior ADC treatment, the ORR was 35.3% with a mDOR of 9.5 months, demonstrating meaningful clinical activity.

In terms of safety, Sevabertinib exhibited good tolerability. The most common treatment-related adverse event was diarrhea, which was mostly mild to moderate. No patients discontinued treatment due to diarrhea, and no cases of interstitial lung disease were reported. Overall, the incidence of serious treatment-related adverse events was low, supporting the feasibility of long-term treatment.

Since 2024, Sevabertinib has received breakthrough therapy designation from both the U.S. FDA and China's CDE. In May 2025, it was granted Priority Review status by the FDA, providing a regulatory pathway for expedited approval. The acceptance of the NDA in China marks another critical milestone in bringing this therapy closer to Chinese patients.

Dr. Dominik Ruettinger, Head of Oncology Research and Early Development at Bayer, stated that the company will continue to collaborate closely with global regulatory authorities to deliver meaningful therapeutic advancements for patients with lung cancer. With ongoing progress in Phase III trials, Sevabertinib has the potential to become a key treatment option for HER2-mutant NSCLC, addressing a major unmet medical need.

According to data from the PatSnap database, Sevabertinib's compound was first disclosed in PCT application WO2020216781A1, filed on April 22, 2020. It has since entered the national phase in 28 countries and regions and has been granted patents in mainland China, Hong Kong, Taiwan, Brazil, Georgia, India, Japan, Singapore, and Vietnam. In China, the granted patent CN114127064B has given rise to two divisional applications (CN117946100A and CN117986251A), both of which are currently under substantive examination.