China approves HERNEXEOS® as first targeted oral treatment option for HER2-mutant advanced NSCLC at initial diagnosis

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About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type⁷ and the incidence is set to increase to over 3 million cases worldwide by 2040.⁸ NSCLC is the most common type of lung cancer.⁷ The condition is often diagnosed at a late stage⁹, and fewer than 3 in 10 patients are alive five years after diagnosis.^9,10 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.^8,11,12

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Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).⁷ Mutations in HER2 can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.¹³

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About HERNEXEOS® (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities. HERNEXEOS is approved in the U.S., China, Hong Kong and Japan as the first orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets.

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The treatment is being evaluated in ongoing trials across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as an initial treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

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About Boehringer Ingelheim in oncology
We have a clear aspiration – to transform the lives of people facing cancer by delivering unprecedented impact, with the ultimate goal to redefine standards of care. Boehringer Ingelheim’s long-term commitment to scientific innovation is reflected by the company’s robust pipeline of cancer cell-directed and immuno-oncology investigational therapies, as well as in smart combinations of these approaches. In everything we do, we focus on people — not just data — working alongside them to develop solutions that truly meet their needs and help move cancer into the background of their lives. This drives our research approach, drawing on diverse minds and a long-term perspective to address the needs of people facing cancer today and for generations to come. Read more at https://www.boehringer-ingelheim.com/human-health/cancer.

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About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

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References

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HERNEXEOS Prescribing Information.
U.S. Food and Drug Administration. FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell (Accessed: May 2026).
Cao, M., Chen, W. Epidemiology of lung cancer in China. Thorac Cancer. 2019 Jan;10(1):3-7.
Li J, Zhang H, Li X, et al. POSC187 Epidemiology of Lung Cancer in China: A Targeted Literature Review. Value in Health, 2022 Jan; 25(1);S137.
Boehringer Ingelheim. Boehringer’s HERNEXEOS approved in China as first oral targeted therapy for previously treated patients with HER2-mutant advanced NSCLC. Available at: https://www.boehringer-ingelheim.com/human-health/cancer/lung-cancer/hernexeos-approved-china-targeted-therapy-nsclc (Accessed: May 2026).
Heymach JV, Yamamoto N, Girard N, et al. First-Line Zongertinib in Advanced HER2-Mutant Non–Small-Cell Lung Cancer. N Engl J Med. 2026(394):1675-1684.
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Presley, C. J. et al. Functional Disability Among Older Versus Younger Adults With Advanced Non–Small-Cell Lung Cancer. JCO Oncol Pract. 2021 May 3;17(6):e848–e858.
Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997.

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