Bayer Wins China Approval for Sevabertinib in Lung Cancer

Berlin, Germany, and Beijing, China, November 4, 2026

NMPA Approves Sevabertinib as First-Line Lung Cancer Treatment

The NMPA approval covers adults with unresectable, locally advanced or metastatic NSCLC carrying HER2-activating mutations. These genetic alterations can drive cancer growth and are associated with a distinct molecular subtype of lung cancer. Identifying these mutations through appropriate molecular testing is important for selecting targeted therapies designed to act on specific cancer-driving mechanisms. The approval is based on objective response rate (ORR) and duration of response (DOR) findings from the treatment-naïve patient cohort of the ongoing Phase I/II SOHO-01 clinical trial (NCT05099172). This study evaluates the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC. In the first-line treatment cohort, which included 73 patients, sevabertinib demonstrated an objective response rate of 75%. This included complete responses in 6% of patients and partial responses in approximately 70%. Furthermore, 73% of patients who achieved a response maintained that response for at least six months, indicating encouraging durability of tumor response in the study population. The safety profile was reported to be consistent with previous clinical findings. These results supported the NMPA’s decision to authorize sevabertinib for first-line use in this specific patient population.

Oral HER2 Inhibitor Targets Cancer-Driving Mutations

Sevabertinib is an oral, reversible, small-molecule tyrosine kinase inhibitor designed to target activating mutations in the HER2 receptor. HER2, also known as human epidermal growth factor receptor 2 or ERBB2, plays an important role in cellular signaling pathways involved in cell growth and survival. Certain activating mutations can cause abnormal signaling that contributes to uncontrolled cancer development. By selectively inhibiting mutant HER2, sevabertinib is designed to interfere with signaling pathways that support tumor growth. Its reversible mechanism of action allows temporary inhibition of the targeted kinase activity. HER2 mutations are identified in approximately 2% to 4% of patients with advanced NSCLC. Although this represents a relatively small proportion of lung cancer cases, affected patients have historically faced limited targeted treatment options. Many patients are diagnosed with advanced disease, making the development of effective molecularly targeted therapies particularly important. The availability of a first-line targeted treatment could help address this unmet medical need by enabling eligible patients to receive therapy directed at the molecular characteristics of their tumors earlier in the treatment journey.

Bayer Advances Global Precision Oncology Development

The latest Chinese authorization follows other important regulatory milestones for sevabertinib. The NMPA had previously approved the medicine for adults with unresectable, locally advanced or metastatic HER2-mutant NSCLC who had received one prior systemic therapy. In September 2026, the U.S. Food and Drug Administration granted accelerated approval for first-line use in eligible adults with advanced HER2-mutant non-squamous NSCLC. Japan has also approved sevabertinib for this patient population. Bayer is continuing to evaluate the medicine through its global clinical development program. The ongoing Phase III SOHO-02 confirmatory study (NCT06452277) is comparing sevabertinib with standard-of-care treatment in previously untreated patients with advanced HER2-mutant NSCLC. The study is intended to verify and further characterize the clinical benefit observed in earlier research. Continued approval in China may be contingent upon confirmation of clinical benefit through this Phase III study. This requirement highlights the importance of additional clinical evidence following an authorization based on response-rate and response-duration data. Overall, China’s first-line approval of sevabertinib marks a significant advancement in targeted lung cancer treatment. By expanding access to a HER2-directed therapy, Bayer is strengthening its precision oncology strategy and addressing an important unmet need in advanced NSCLC. Further results from SOHO-02 will be important in establishing the medicine’s long-term clinical benefit.

Source: Bayer press release