AstraZeneca completes global license agreement for oral EGFR inhibitor ZEGFROVY® (sunvozertinib) for lung cancer

AstraZeneca today announced the successful completion of thepreviously announced exclusive license agreementwith Dizal Pharmaceutical Co., Ltd forZegfrovy(sunvozertinib), an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialiseZegfrovy.

Zegfrovyis approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) withEGFRexon 20 insertion mutations. Patients with NSCLC withEGFRexon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8%underscoring the unmet need for new treatment options.1Zegfrovyis already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication.

Sunvozertinib (Zegfrovy)is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC. It is recommended as a subsequent therapy option for patients withEGFRexon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines®for detailed recommendations.2

A supplemental New Drug Application for approval ofZegfrovyin the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial ofZegfrovyin 1st-line NSCLC withEGFRexon 20 insertion mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published inThe New England Journal of Medicine.Zegfrovyhas also been submitted for approval in the 1st-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation toZegfrovyin this setting.

Financial considerationsAstraZeneca will make an upfront payment of $600m to Dizal together with additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales ofZegfrovy.

NSCLCLung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.3Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.3-4Approximately 75% of people are diagnosed with advanced NSCLC.5Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia haveEGFRm NSCLC.6-8

ZegfrovyZegfrovyis an irreversible EGFR inhibitor targeting a wide spectrum ofEGFRmutations with wild-typeEGFRselectivity.Zegfrovyis approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC withEGFRexon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Supplemental New Drug Applications for approval ofZegfrovyin the 1st-line setting have also been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation toZegfrovyin this setting.

AstraZeneca in lung cancerAstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, includingTagrissoandIressa(gefitinib);Imfinzi(durvalumab) andImjudo(tremelimumab);Zegfrovy(sunvozertinib);Enhertu(trastuzumab deruxtecan) andDatroway(datopotamab deruxtecan) in collaboration with Daiichi Sankyo;Orpathys(savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in oncologyAstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZenecaAstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Social Media@AstraZeneca.

1. Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboringEGFRexon 20 insertion mutations and commonEGFRmutations. Lung Cancer, 2021; 162, 154-161.

2. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026).https://www.nccn.org/login?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 2026. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

3. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at:https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.  Accessed August 2025.

4. American Cancer Society. What Is Lung Cancer?. Available at:https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html.  Accessed August 2025.

5. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688.

6. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.

7. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812.

8. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89.

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