{"id":82757,"date":"2026-07-14T12:37:07","date_gmt":"2026-07-14T12:37:07","guid":{"rendered":"https:\/\/www.europesays.com\/britain\/82757\/"},"modified":"2026-07-14T12:37:07","modified_gmt":"2026-07-14T12:37:07","slug":"astrazeneca-licenses-lung-cancer-drug-zegfrovy-azn-sec-filing","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/britain\/82757\/","title":{"rendered":"AstraZeneca licenses lung cancer drug Zegfrovy | AZN SEC Filing"},"content":{"rendered":"<p>FORM 6-K<\/p>\n<p>\u00a0<\/p>\n<p>\nSECURITIES<br \/>\nAND EXCHANGE COMMISSION<\/p>\n<p>\nWashington,<br \/>\nD.C. 20549<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\nReport<br \/>\nof Foreign Issuer<\/p>\n<p>\u00a0<\/p>\n<p>\nPursuant<br \/>\nto Rule 13a-16 or 15d-16 of<\/p>\n<p>\nthe<br \/>\nSecurities Exchange Act of 1934<\/p>\n<p>\n\u00a0<\/p>\n<p>\nFor the<br \/>\nmonth of July 2026\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\nCommission<br \/>\nFile Number: 001-11960<\/p>\n<p>\n\u00a0<\/p>\n<p>AstraZeneca PLC<\/p>\n<p>\n\u00a0<\/p>\n<p>\n1<br \/>\nFrancis Crick Avenue<\/p>\n<p>\nCambridge<br \/>\nBiomedical Campus<\/p>\n<p>\nCambridge<br \/>\nCB2 0AA<\/p>\n<p>\nUnited<br \/>\nKingdom<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark whether the registrant files or will file annual<br \/>\nreports under cover of Form 20-F or Form 40-F.<\/p>\n<p>\u00a0<\/p>\n<p>\nForm<br \/>\n20-F X Form 40-F __<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark if the registrant is submitting the Form 6-K in paper<br \/>\nas permitted by Regulation S-T Rule 101(b)(1):<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark if the registrant is submitting the Form 6-K in paper<br \/>\nas permitted by Regulation S-T Rule 101(b)(7): ______<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark whether the registrant by furnishing the information<br \/>\ncontained in this Form is also thereby furnishing the information<br \/>\nto the Commission pursuant to Rule 12g3-2(b) under the Securities<br \/>\nExchange Act of 1934.<\/p>\n<p>\u00a0<\/p>\n<p>\nYes __<br \/>\nNo X<\/p>\n<p>\u00a0<\/p>\n<p>\nIf<br \/>\n\u201cYes\u201d is marked, indicate below the file number<br \/>\nassigned to the Registrant in connection with Rule 12g3-2(b):<br \/>\n82-_____________<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>AstraZeneca PLC<\/p>\n<p>\n\u00a0<\/p>\n<p>\nINDEX<br \/>\nTO EXHIBITS<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>1.<\/p>\n<p>\nAstraZeneca licenses novel EGFR inhibitor<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a014 July 2026<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca enters exclusive global license agreement<br \/>\nfor\u00a0novel<br \/>\noral\u00a0EGFR<br \/>\ninhibitor\u00a0Zegfrovy\u00a0for lung cancer with Dizal<br \/>\nPharmaceutical<\/p>\n<p>\u00a0<\/p>\n<p>Complements AstraZeneca&#8217;s leading portfolio of medicines targeting<br \/>\nEGFR mutations<\/p>\n<p>\u00a0<\/p>\n<p>Zegfrovy is approved in the US and China to treat lung cancer<br \/>\npatients whose tumours carry exon 20 insertion<br \/>\nmutations<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca has entered into an exclusive license agreement with<br \/>\nDizal Pharmaceutical Co., Ltd for\u00a0Zegfrovy\u00a0(sunvozertinib), a novel oral<br \/>\nirreversible\u00a0epidermal growth factor receptor<br \/>\n(EGFR)\u00a0inhibitor for patients with lung<br \/>\ncancer.\u00a0AstraZeneca will acquire worldwide rights to develop<br \/>\nand commercialise\u00a0Zegfrovy.<\/p>\n<p>\u00a0<\/p>\n<p>Zegfrovy\u00a0is approved in<br \/>\nthe US and China for the treatment of adult patients with locally<br \/>\nadvanced or metastatic non-small cell lung cancer (NSCLC)<br \/>\nwith\u00a0EGFR\u00a0exon 20 insertion mutations, whose disease<br \/>\nhas progressed on or after platinum-based<br \/>\nchemotherapy.<\/p>\n<p>\u00a0<\/p>\n<p>Approximately 80-85% of lung cancer patients globally have NSCLC.<br \/>\nAbout 10-15% of NSCLC patients in the US and Europe, and 30-40% of<br \/>\npatients in Asia, have\u00a0EGFR-mutated (EGFRm) NSCLC. Roughly one in four patients<br \/>\nwith\u00a0EGFRm NSCLC has a tumour with an\u00a0exon 20<br \/>\ninsertion mutation\u00a0or other atypical mutation for which<br \/>\ntargeted treatment options are limited.<\/p>\n<p>\u00a0<\/p>\n<p>Dave Fredrickson, Executive Vice President, Oncology Haematology<br \/>\nBusiness Unit, AstraZeneca, said: &#8220;AstraZeneca is a leader in<br \/>\ntreating\u00a0EGFR-mutated lung cancer, and we are eager to<br \/>\nadd\u00a0Zegfrovy\u00a0to our world-class portfolio of innovative<br \/>\nmedicines for patients whose tumours carry exon 20 insertion<br \/>\nmutations. With\u00a0this agreement, we will bring a<br \/>\ndifferentiated, oral targeted treatment to these patients with<br \/>\nlimited options across the globe.&#8221;<\/p>\n<p>\u00a0<\/p>\n<p>Dr.\u00a0Xiaolin Zhang, Chief Executive Officer of Dizal said: &#8220;As<br \/>\na leading global company with a strong lung cancer franchise,<br \/>\nAstraZeneca will help ensure patients around the world can benefit<br \/>\nfrom this innovation discovered by Dizal scientists in<br \/>\nChina.\u00a0Zegfrovy\u00a0is the only oral targeted therapy<br \/>\nfor\u00a0EGFR\u00a0exon 20 insertion non-small cell lung cancer<br \/>\napproved in the US and China for patients following prior systemic<br \/>\ntherapy.&#8221;<\/p>\n<p>\u00a0<\/p>\n<p>Dizal recently announced positive results from the global WU-KONG28<br \/>\nPhase III trial of\u00a0Zegfrovy\u00a0in 1st-line NSCLC with exon 20<br \/>\ninsertion\u00a0EGFR\u00a0mutations. These data were presented as a<br \/>\nLate-Breaking Abstract Oral Presentation at the 2026 American<br \/>\nSociety of Clinical Oncology Annual Meeting and simultaneously<br \/>\npublished in\u00a0The<br \/>\nNew England Journal of Medicine.<\/p>\n<p>\u00a0<\/p>\n<p>Supported by these results, a Supplemental New Drug Application for<br \/>\napproval in the 1st-line setting has been submitted to the US Food<br \/>\nand Drug Administration (FDA) and China&#8217;s Center for Drug<br \/>\nEvaluation (CDE). The US FDA and China&#8217;s CDE have also both granted<br \/>\nBreakthrough Therapy Designation to\u00a0Zegfrovy\u00a0in this setting.<\/p>\n<p>\u00a0<\/p>\n<p>Sunvozertinib (Zegfrovy)\u00a0is included in the NCCN Clinical Practice<br \/>\nGuidelines in Oncology (NCCN Guidelines\u00ae) for NSCLC as a<br \/>\nCategory 2A recommended subsequent therapy option for patients<br \/>\nwith\u00a0EGFR\u00a0exon 20 insertion mutation-positive advanced<br \/>\nor metastatic NSCLC. See NCCN Guidelines\u00ae\u00a0for detailed<br \/>\nrecommendations.1<\/p>\n<p>\u00a0<\/p>\n<p>Financial considerations<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca will make an upfront payment to Dizal of $600m and<br \/>\nadditional payments of up to\u00a0$900m\u00a0upon achievement of specific development,<br \/>\nregulatory and sales-related milestones. Additionally, Dizal will<br \/>\nreceive tiered royalties on the global sales<br \/>\nof\u00a0Zegfrovy.<\/p>\n<p>\u00a0<\/p>\n<p>The transaction is expected to close in the second half of 2026,<br \/>\nsubject to customary closing conditions and regulatory clearances.<br \/>\nThe transaction does not impact AstraZeneca&#8217;s financial guidance<br \/>\nfor 2026.<\/p>\n<p>\u00a0<\/p>\n<p>Notes<\/p>\n<p>\u00a0<\/p>\n<p>NSCLC<\/p>\n<p>Lung cancer is the leading cause of cancer death among men and<br \/>\nwomen, accounting for about one-fifth of all cancer<br \/>\ndeaths.2\u00a0Lung<br \/>\ncancer is broadly split into small cell lung cancer or NSCLC, the<br \/>\nlatter accounting for 80-85% of cases.2-3\u00a0Approximately<br \/>\n75% of people are diagnosed with advanced NSCLC.4\u00a0Additionally,<br \/>\nabout 10-15% of NSCLC patients in the US and Europe, and 30-40% of<br \/>\npatients in Asia have\u00a0EGFRm NSCLC.5-7<\/p>\n<p>\u00a0<\/p>\n<p>Zegfrovy<\/p>\n<p>Zegfrovy\u00a0is an<br \/>\nirreversible EGFR inhibitor targeting a wide spectrum<br \/>\nof\u00a0EGFR\u00a0mutations with<br \/>\nwild-type\u00a0EGFR\u00a0selectivity.\u00a0Zegfrovy\u00a0is approved in the US and China for the<br \/>\ntreatment of adult patients with locally advanced or metastatic<br \/>\nNSCLC with\u00a0EGFR\u00a0exon 20 insertion mutations, whose disease<br \/>\nhas progressed on or after platinum-based<br \/>\nchemotherapy.<\/p>\n<p>\u00a0<\/p>\n<p>In addition,\u00a0Zegfrovy\u00a0also demonstrated encouraging anti-tumour<br \/>\nactivity in NSCLC patients with EGFR sensitizing, T790M, and<br \/>\nuncommon mutations, as well as HER2 exon 20<br \/>\ninsertions.\u00a0Zegfrovy\u00a0showed a well-tolerated and manageable<br \/>\nsafety profile in the clinic. The most common drug-related<br \/>\ntreatment-emergent adverse events were Grade 1\/2 in nature and<br \/>\nclinically manageable.<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca in lung cancer<\/p>\n<p>AstraZeneca is working to bring patients with lung cancer closer to<br \/>\ncure through the detection and treatment of early-stage disease,<br \/>\nwhile also pushing the boundaries of science to improve outcomes in<br \/>\nthe resistant and advanced settings. By defining new therapeutic<br \/>\ntargets and investigating in innovative approaches, the Company<br \/>\naims to match medicines to the patients who can benefit<br \/>\nmost.<\/p>\n<p>\u00a0<\/p>\n<p>\nThe<br \/>\nCompany\u2019s comprehensive portfolio includes leading lung<br \/>\ncancer medicines and the next wave of innovations, including<br \/>\nTagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and<br \/>\nDatroway (datopotamab<br \/>\nderuxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration<br \/>\nwith HUTCHMED; as well as a pipeline of potential new medicines and<br \/>\ncombinations across diverse mechanisms of action.<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca is a founding member of the Lung Ambition Alliance, a<br \/>\nglobal coalition working to accelerate innovation and deliver<br \/>\nmeaningful improvements for people with lung cancer, including and<br \/>\nbeyond treatment.<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca in oncology\u00a0<\/p>\n<p>AstraZeneca is leading a revolution in oncology with the ambition<br \/>\nto provide cures for cancer in every form, following the science<br \/>\nto\u00a0understand\u00a0cancer and all its complexities to<br \/>\ndiscover, develop and deliver life-changing medicines to<br \/>\npatients.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>The Company&#8217;s focus is on some of the most challenging cancers. It<br \/>\nis through persistent innovation that AstraZeneca has built one of<br \/>\nthe most diverse portfolios and pipelines in the industry, with the<br \/>\npotential to catalyse changes in the practice of medicine and<br \/>\ntransform the patient experience.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca has the vision to redefine cancer care and, one<br \/>\nday,\u00a0eliminate\u00a0cancer as a cause of<br \/>\ndeath.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca<\/p>\n<p>AstraZeneca (LSE\/STO\/NYSE: AZN) is a global, science-led<br \/>\nbiopharmaceutical company that focuses on the discovery,<br \/>\ndevelopment, and commercialisation of prescription medicines in<br \/>\nOncology, Rare Disease, and BioPharmaceuticals, including<br \/>\nCardiovascular, Renal &amp; Metabolism, and Respiratory &amp;<br \/>\nImmunology. Based in Cambridge, UK, AstraZeneca&#8217;s innovative<br \/>\nmedicines are sold in more than 125 countries and used by millions<br \/>\nof patients worldwide. Please visit\u00a0astrazeneca.com\u00a0and<br \/>\nfollow the Company on Social Media\u00a0@AstraZeneca.<\/p>\n<p>\u00a0<\/p>\n<p>Contacts<\/p>\n<p>For details on how to contact the Investor Relations Team, please<br \/>\nclick\u00a0here.<br \/>\nFor Media contacts, click\u00a0here.<\/p>\n<p>\u00a0<\/p>\n<p>References<\/p>\n<p>\n1.\u00a0 \u00a0 \u00a0National Comprehensive<br \/>\nCancer Network. Non-Small Cell Lung Cancer. (Version<br \/>\n6.2026).\u00a0https:\/\/www.nccn.org\/login?ReturnURL=https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/nscl.pdf.<br \/>\nAccessed July 2026. NCCN makes no warranties of any kind whatsoever<br \/>\nregarding their content, use or application and disclaims any<br \/>\nresponsibility for their application or use in any<br \/>\nway.<\/p>\n<p>\n2.\u00a0 \u00a0 World Health Organization.<br \/>\nInternational Agency for Research on Cancer. Lung Cancer Fact<br \/>\nSheet. Available at:\u00a0https:\/\/gco.iarc.who.int\/media\/globocan\/factsheets\/cancers\/15-trachea-bronchus-and-lung-fact-sheet.pdf.<br \/>\n\u00a0Accessed August 2025.<\/p>\n<p>\n3.\u00a0 \u00a0 American Cancer Society. What Is<br \/>\nLung Cancer?. Available at:\u00a0https:\/\/www.cancer.org\/cancer\/types\/lung-cancer\/about\/what-is.html.<br \/>\n\u00a0Accessed August 2025.<\/p>\n<p>\n4.\u00a0<br \/>\n\u00a0 Chen HJ, et al. Long-term survival of advanced lung<br \/>\nadenocarcinoma by maintenance chemotherapy followed by<br \/>\nEGFR-TKI.\u00a0Medicine. 2021;100(6):e24688.<\/p>\n<p>\n5.\u00a0<br \/>\n\u00a0 Keedy VL, et al. American Society of Clinical Oncology<br \/>\nProvisional Clinical Opinion: Epidermal Growth Factor Receptor<br \/>\n(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell<br \/>\nLung Cancer Considering First Line EGFR Tyrosine Kinase Inhibitor<br \/>\nTherapy.\u00a0J Clin Oncol. 2011:29;2121-27.<\/p>\n<p>\n6.\u00a0<br \/>\n\u00a0 Szumera-Cie\u0107kiewicz A, et al.\u00a0EGFR Mutation<br \/>\nTesting on Cytological and Histological Samples in Non-Small Cell<br \/>\nLung Cancer: a Polish, Single Institution Study and Systematic<br \/>\nReview of European Incidence.\u00a0Int J Clin Exp Pathol.<br \/>\n2013;6:2800-2812.<\/p>\n<p>\n7.\u00a0<br \/>\n\u00a0 Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a<br \/>\nReview of Available Methods and Their Use for Analysis of Tumour<br \/>\nTissue and Cytology Samples.\u00a0J Clin Pathol.<br \/>\n2013;66:79-89.<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>Matthew Bowden<\/p>\n<p>Company Secretary<\/p>\n<p>AstraZeneca PLC<\/p>\n<p>\n\u00a0<\/p>\n<p>SIGNATURES<\/p>\n<p>\u00a0<\/p>\n<p>\nPursuant<br \/>\nto the requirements of the Securities Exchange Act of 1934, the<br \/>\nRegistrant has duly caused this report to be signed on its behalf<br \/>\nby the undersigned, thereunto duly authorized.<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>Date: 14 July 2026<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\nBy: \/s\/<br \/>\nMatthew Bowden<\/p>\n<p>\u00a0<\/p>\n<p>\nName:<br \/>\nMatthew Bowden<\/p>\n<p>\u00a0<\/p>\n<p>\nTitle:<br \/>\nCompany Secretary<\/p>\n","protected":false},"excerpt":{"rendered":"FORM 6-K \u00a0 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 \u00a0 \u00a0 Report of Foreign Issuer \u00a0 Pursuant&hellip;\n","protected":false},"author":2,"featured_media":72847,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[20662],"tags":[11153,21721,36595,36596,28736,35519,36597,36514,36526],"class_list":["post-82757","post","type-post","status-publish","format-standard","has-post-thumbnail","category-astrazeneca","tag-astrazeneca","tag-azn","tag-egfr-exon-20","tag-license-agreement","tag-non-small-cell-lung-cancer","tag-oncology-drug","tag-royalty-deal","tag-sunvozertinib","tag-zegfrovy"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@UnitedKingdom\/116918369895054847","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/82757","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/comments?post=82757"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/82757\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media\/72847"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media?parent=82757"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/categories?post=82757"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/tags?post=82757"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}