FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca licenses novel EGFR inhibitor
14 July 2026
AstraZeneca enters exclusive global license agreement
for novel
oral EGFR
inhibitor Zegfrovy for lung cancer with Dizal
Pharmaceutical
Complements AstraZeneca's leading portfolio of medicines targeting
EGFR mutations
Zegfrovy is approved in the US and China to treat lung cancer
patients whose tumours carry exon 20 insertion
mutations
AstraZeneca has entered into an exclusive license agreement with
Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), a novel oral
irreversible epidermal growth factor receptor
(EGFR) inhibitor for patients with lung
cancer. AstraZeneca will acquire worldwide rights to develop
and commercialise Zegfrovy.
Zegfrovy is approved in
the US and China for the treatment of adult patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC)
with EGFR exon 20 insertion mutations, whose disease
has progressed on or after platinum-based
chemotherapy.
Approximately 80-85% of lung cancer patients globally have NSCLC.
About 10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia, have EGFR-mutated (EGFRm) NSCLC. Roughly one in four patients
with EGFRm NSCLC has a tumour with an exon 20
insertion mutation or other atypical mutation for which
targeted treatment options are limited.
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "AstraZeneca is a leader in
treating EGFR-mutated lung cancer, and we are eager to
add Zegfrovy to our world-class portfolio of innovative
medicines for patients whose tumours carry exon 20 insertion
mutations. With this agreement, we will bring a
differentiated, oral targeted treatment to these patients with
limited options across the globe."
Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: "As
a leading global company with a strong lung cancer franchise,
AstraZeneca will help ensure patients around the world can benefit
from this innovation discovered by Dizal scientists in
China. Zegfrovy is the only oral targeted therapy
for EGFR exon 20 insertion non-small cell lung cancer
approved in the US and China for patients following prior systemic
therapy."
Dizal recently announced positive results from the global WU-KONG28
Phase III trial of Zegfrovy in 1st-line NSCLC with exon 20
insertion EGFR 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 in The
New England Journal of Medicine.
Supported by these results, a Supplemental New Drug Application for
approval in the 1st-line setting has 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 have also both granted
Breakthrough Therapy Designation to Zegfrovy in this setting.
Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines®) for NSCLC as a
Category 2A recommended subsequent therapy option for patients
with EGFR exon 20 insertion mutation-positive advanced
or metastatic NSCLC. See NCCN Guidelines® for detailed
recommendations.1
Financial considerations
AstraZeneca will make an upfront payment to Dizal of $600m and
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
of Zegfrovy.
The transaction is expected to close in the second half of 2026,
subject to customary closing conditions and regulatory clearances.
The transaction does not impact AstraZeneca's financial guidance
for 2026.
Notes
NSCLC
Lung cancer is the leading cause of cancer death among men and
women, accounting for about one-fifth of all cancer
deaths.2 Lung
cancer is broadly split into small cell lung cancer or NSCLC, the
latter accounting for 80-85% of cases.2-3 Approximately
75% of people are diagnosed with advanced NSCLC.4 Additionally,
about 10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFRm NSCLC.5-7
Zegfrovy
Zegfrovy is an
irreversible EGFR inhibitor targeting a wide spectrum
of EGFR mutations with
wild-type EGFR selectivity. Zegfrovy is approved in the US and China for the
treatment of adult patients with locally advanced or metastatic
NSCLC with EGFR exon 20 insertion mutations, whose disease
has progressed on or after platinum-based
chemotherapy.
In addition, Zegfrovy also demonstrated encouraging anti-tumour
activity in NSCLC patients with EGFR sensitizing, T790M, and
uncommon mutations, as well as HER2 exon 20
insertions. Zegfrovy showed a well-tolerated and manageable
safety profile in the clinic. The most common drug-related
treatment-emergent adverse events were Grade 1/2 in nature and
clinically manageable.
AstraZeneca in lung cancer
AstraZeneca 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, including
Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and
Datroway (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 oncology
AstraZeneca 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.
AstraZeneca
AstraZeneca (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 visit astrazeneca.com and
follow the Company on Social Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. 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.
2. 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.
3. American Cancer Society. What Is
Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html.
Accessed August 2025.
4.
Chen HJ, et al. Long-term survival of advanced lung
adenocarcinoma by maintenance chemotherapy followed by
EGFR-TKI. Medicine. 2021;100(6):e24688.
5.
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.
6.
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.
7.
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.
Matthew Bowden
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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AstraZeneca
PLC
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Date: 14 July 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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