Zongertinib

Strong U.S. demand and new product launches drive first-half sales in Human Pharma Net sales reach EUR 15.8 billion, led by JARDIANCE® and successful U.S. launches Positive Phase III data for survodutide and pipeline progress strengthen long-term outlook Boehringer Ingelheim reported continued sales growth in the first half of 2026, driven by strong growth in the U.S. due to increased demand for JARDIANCE® (empagliflozin) and successful new launches. Group net sales increased by 16.2%* to EUR 15.8 billion, with Human Pharma contributing EUR 13.1 billion and Animal Health EUR 2.6 billion. Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim said: “The strong uptake of our new products JASCAYD® and HERNEXEOS® show the value of the scientific innovation behind these medicines for patients, bringing real progress in areas with significant unmet medical need. In an era of accelerated medical discovery, where the boundaries of what is possible are continuously expanding, innovation-friendly environments such as the United States play a critical role in ensuring new therapies reach patients more rapidly.” Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: “Our business results show that, in Human Pharma and Animal Health, we successfully navigated a challenging macroeconomic environment and political uncertainties. We remain focused on delivering innovative medicines to patients and animals worldwide. Looking ahead, we need to direct our long-term investments to where they are closest to our growth markets and where they can create the best possible impact for patients. This also includes engaging with governments around the globe to create an environment that appropriately recognizes the value of innovative medicines and ensures patient access.” Human Pharma: Growth supported by key launches Human Pharma sales grew 20.1%* to EUR 13.1 billion, supported by the new product launches. Established products such as JARDIANCE® for the treatment of chronic kidney disease, type 2 diabetes and heart failure remained major growth drivers, contributing EUR 5.7 billion in net sales in the first half of the year. The positive development of JARDIANCE® was supported by a large and growing patient base, as well as changes in the U.S. pricing and reimbursement environment, which drove significant volume growth. This trend is in line with Boehringer’s commitment to ensuring continued patient access and affordability. Without the JARDIANCE® volume effect, the growth of the Human Pharma Business Unit in the first six months would have been in line with the overall pharma market. The company also saw a successful uptake of its most recent product launches, JASCAYD® (nerandomilast) and HERNEXEOS® (zongertinib), particularly in the U.S., as both medicines were able to gain significant traction thanks to the innovation-friendly climate in the U.S. but also in China and Japan. Streamlined processes as well as stronger incentives for innovation in these geographies paved the way for swiftly making these breakthrough medicines available to patients. JASCAYD®, for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), saw a strong uptake reflecting the urgent need for new treatment options in a disease area that has seen limited therapeutic progress for many years. Following approvals in the United States, China and Japan, as well as Thailand, the United Arab Emirates, the UK and Brazil, JASCAYD® is awaiting EU approval from the European Medicines Agency (EMA). HERNEXEOS®, an oral treatment for HER2-mutant advanced non-small cell lung cancer, marked the company’s successful re-entry into oncology after ten years with launches in the U.S., China and Japan. The company expects that HERNEXEOS® will be available for European patients only from 2028 after Phase III data becomes available. Boehringer continued to advance its late-stage pipeline programs during the first half of 2026, realizing significant progress in oncology and cardio-renal-metabolic diseases. Positive Phase III data for survodutide demonstrated the medicine’s potential to address metabolic and liver health in addition to overweight and obesity. Progress with a next-generation triple agonist underlines Boehringer’s ambition to build a broad obesity and metabolic health portfolio. At the same time, Boehringer Ingelheim initiated three Phase III oncology trials, reinforcing its goal to expand precision cancer care. The company also advanced key assets such as obrixtamig, an experimental cancer immunotherapy, and apecotrep, an investigational drug targeting kidney disease. Research momentum also continued to be strong, with five new compounds entering clinical trials. The Boehringer Human Pharma R&D pipeline spans around 80 projects. Animal Health: Focus on new launches and emerging disease outbreaks response The Animal Health business reported net sales of EUR 2.6 billion in the first six months of 2026, a 0.4%* increase compared to the previous year. The performance reflected a modestly growing animal health market, with increased consumer price sensitivity and fewer veterinary visits in several countries. The company continues to execute its 2026 launch plan, including LENZELTA®, a new vaccine that advances mastitis prevention in dairy cows and has launched in several EU countries, and Eko Vet+™ | CANINEBEAT® AI, an AI-based solution that helps detect heart murmurs in dogs and has already launched in the U.S., the UK and Germany. Boehringer Ingelheim also continues to support responses to emerging animal disease outbreaks, including New World screwworm in the U.S., after receiving Emergency Use Authorizations (EUAs) earlier this year from the U.S. Food and Drug Administration. The company continues to progress its R&D pipeline in Animal Health, with strong candidates across infectious and non-infectious diseases as well as parasiticides, building a solid innovation foundation for the future in pets, equine, and livestock animals. Outlook Looking ahead, Boehringer expects that uptake of recent launches, upcoming pipeline milestones, and ongoing investments in innovation will support performance for the remainder of the year and beyond. At the same time, the company will remain focused on navigating a dynamic external environment while maintaining a balanced and disciplined approach to growth. 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 .

Boehringer Ingelheim is committed to improving outcomes for people facing aggressive cancers where there are currently few treatment options DAREON®-Lung-1 and DAREON®-NEC-1 will evaluate obrixtamig, Boehringer's immunoglobin G (IgG)-like bispecific T-cell engager, as a DLL3 biomarker-informed approach designed to help identify patients and inform treatment decisions for small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC)1,2 Beamion LUNG-3 will explore HERNEXEOS® (zongertinib tablets) in earlier stages of disease in resectable HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC), where new targeted treatment options are still needed3 June 22, 2026 -- Boehringer Ingelheim is advancing biomarker-informed approaches and extending precision care across multiple cancers and stages of disease, reinforcing its ambition to bring unprecedented impact and improve long-term outcomes where unmet need remains high.4,5,6 The company has initiated two Phase III clinical trials within the DAREON® program: DAREON®-Lung-1 in small cell lung cancer (SCLC) and DAREON®-NEC-1 in extrapulmonary neuroendocrine carcinoma (epNEC). In parallel, the Phase III Beamion LUNG-3 trial has been initiated in HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC).4,5,6 "People living with aggressive cancers often face a shortage of treatment choices," said Lykke Hinsch Gylvin, MD, Chief Medical Officer, Boehringer Ingelheim. "With the launch of these trials, we are advancing our precision oncology ambitions to move targeted therapies into earlier treatment lines and bring biomarker-informed science into late-stage development. By focusing on the biology of each tumor, we aim to give patients facing cancer more precise treatment options with the goal of improving outcomes where the need is greatest." The two DAREON® Phase III trials mark a pivotal step for obrixtamig, Boehringer's investigational DLL3/CD3 T-cell engager, and for the company's broader biomarker strategy in aggressive neuroendocrine carcinomas (NECs) such as SCLC and epNEC. People with SCLC, the most aggressive type of lung cancer, often face short-lived therapeutic benefit and poor survival with existing approaches.5,7 EpNEC is a historically under-researched cancer for which survival outcomes have not improved in decades. For those living with these cancers, treatment options are limited and significant unmet needs persist.7,8 Delta-like canonical Notch ligand 3 (DLL3) is expressed on tumor cells in SCLC and epNEC while largely absent from non-cancerous cells. This makes it a potential predictive biomarker that could help to redefine treatment strategies for these aggressive cancers.9,10 DAREON®-Lung-1 and DAREON®-NEC-1 are designed to test whether the addition of obrixtamig, a DLL3 targeted T-cell engager, can improve outcomes in biomarker-informed patient populations versus the current standard of care.1,2 Together, the studies aim to position obrixtamig as part of a broader shift toward more personalized and potentially more transformative treatment approaches in these aggressive NECs. In addition, the company is investigating HERNEXEOS® (zongertinib tablets) in earlier stages of disease with the initiation of Beamion LUNG-3. This global, randomized Phase III trial will study the efficacy and safety of HERNEXEOS as adjuvant monotherapy compared with physician's choice standard of care in patients with stage II-IIIB HER2 (ERBB2)-mutant NSCLC who have undergone complete surgical resection and have received either neoadjuvant or adjuvant therapy.3 The study is designed to evaluate whether HERNEXEOS can improve disease-free survival compared to standard of care following surgery, addressing the significant risk of recurrence after curative-intent treatment.11 Beamion LUNG-3 reflects the company's focus on advancing targeted therapies earlier in the treatment pathway, where effective targeted adjuvant treatment options are not available.12 This trial extends the investigation of zongertinib to early stage disease.3 Boehringer Ingelheim continues to expand its portfolio of precision oncology approaches that combine targeted therapies for biomarker-defined populations with innovative strategies to both activate and direct the immune system. This includes next-generation immunotherapies such as T-cell engagers, alongside complementary modalities that aim to enhance anti-tumor responses and address tumor-intrinsic drivers of disease. By integrating these approaches, the company aims to expand treatment options for people facing cancers with high unmet medical need. Obrixtamig is an investigational novel Immunoglobin G (IgG)-like bispecific T-cell engager designed to bind concomitantly to DLL3 on tumor cells and CD3 on T-cells, potentially resulting in destruction of tumor cells by the body's own immune system. Obrixtamig is being evaluated in multiple, ongoing clinical trials, including a Phase I trial in combination with atezolizumab and chemotherapy in extensive-stage small-cell lung cancer (ES-SCLC) patients (DAREON®-8), a Phase Ib study to investigate obrixtamig in combination with the current SoC (carboplatin + etoposide) as 1L treatment for patients with DLL3-positive NEC, including epNEC (DAREON®-7), and a Phase II trial in patients with relapsed/refractory DLL3-high extrapulmonary neuroendocrine carcinomas (epNEC) (DAREON®-5).13,14,15 The Phase III clinical development program includes DAREON®-LUNG-1, which evaluates obrixtamig in combination with atezolizumab plus chemotherapy vs. atezolizumab plus chemotherapy for first-line use in patients with ES-SCLC.1 In addition, DAREON®-NEC-1 is evaluating obrixtamig in combination with current SoC (carboplatin and etoposide) vs. SoC alone as first-line therapy in patients with DLL3-positive unresectable locally advanced or metastatic epNEC.2 In order to tackle hard-to-treat cancers, Boehringer is drawing on innovation enabled through collaboration. The company is developing obrixtamig through a long-term partnership with Oxford BioTherapeutics (OBT), using OBT's OGAP® platform to identify novel target opportunities for new immunotherapies harnessing its investigational T-cell engager, investigational cancer vaccine and exploratory oncolytic virus platforms. HERNEXEOS® (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2).16 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer.16 Comprehensive biomarker testing using next generation sequencing determines a patient's eligibility for treatment with HERNEXEOS by identifying HER2 (ERBB2)-mutant advanced NSCLC.16,17 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 HERNEXEOS as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574).18 Beamion LUNG-3 is a Phase III clinical trial investigating HERNEXEOS as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).3 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. 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. Xu J, Li Y, Xu B, Lian J, Lu H. Clinical characteristics and survival outcomes of extrapulmonary neuroendocrine carcinomas: a retrospective study. Front Endocrinol (Lausanne). 2025;16:1635630. Published 2025 Oct 27. doi:10.3389/fendo.2025.1635630 Plaja A, et al. Small-Cell Lung Cancer Long-Term Survivor Patients : How to Find a Needle in a Haystack?. Int J Mol Sci. 2021;22(24):13508. Published 2021 Dec 16. doi:10.3390/ijms222413508 Jeon H, Wang S, Song J, Gill H, Cheng H. Update 2025: Management of Non Small-Cell Lung Cancer. Lung. 2025;203(1):53. Published 2025 Mar 25. doi:10.1007/s00408-025-00801-x Uprety D, Seaton R, Niroula A, Hadid T, Parikh K, Ruterbusch JJ. Trends in the incidence and survival outcomes in patients with small cell lung cancer in the United States: an analysis of the SEER database. Cancer Med. 2025;14(3):e70608. doi:10.1002/cam4.70608 Frizziero M, Chakrabarty B, Nagy B, et al. Is the morphological subtype of extra-pulmonary poorly differentiated neuroendocrine carcinoma clinically relevant? Cancers (Basel). 2021;13(16):3986 Liverani C, Bongiovanni A, Mercatali L, et al. Diagnostic and Predictive Role of DLL3 Expression in Gastroenteropancreatic Neuroendocrine Neoplasms. Endocr Pathol. 2021;32(2):309-317. doi:10.1007/s12022-020-09657-81 Wermke M, et al. Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas. J Clin Oncol 2025;43(27):3021–31. Brandon, S. et al. Risk factors and survival associated with lung cancer recurrence after curative-intent surgery: beyond TNM pathological staging. Journal Of Thoracic Disease. 2025;17(11):10285-10297. Hao S, Zhao S, Shi L, Zhong L, Wei H, Jiao X, Xue C. Targeting rare oncogenic mutations in resectable non-small cell lung cancer: emerging perioperative strategies. Journal of Thoracic Disease. 2026;18(2) Peters, S, et al. DAREON®-8: updated efficacy and safety from a phase I dose-escalation/expansion trial of first-line (1L) obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC). Poster presented at: American Society of Clinical Oncology Annual Meeting; May 29 – June 2, 2026; Chicago, IL. ClinicalTrials.gov. DAREON-7 (NCT06132113). Accessed June 2026. ClinicalTrials.gov. DAREON-5 (NCT05882058). Accessed June 2026. HERNEXEOS Prescribing Information. Zeng J, Ma W, Young RB, Li T. Targeting HER2 genomic alterations in non-small cell lung cancer. J Natl Cancer Cent. 2021;1(2):58-73. ClinicalTrials.gov. Beamion LUNG-2 (NCT06151574). Accessed June 2026. The content above comes from the network. if any infringement, please contact us to modify.