阿斯利康完成对迪哲医药EGFR抑制剂Zegfrovy（sunvozertinib）的全球独家许可交易交割

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6-K
1
a7349s.htm
ASTRAZENECA COMPLETES AGREEMENT FOR ZEGFROVY
a7349s
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 September 2026
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca completes agreement for Zegfrovy
01 September 2026
AstraZeneca completes global license agreement
for
oral
EGFR
inhibitor
Zegfrovy
for
lung cancer
AstraZeneca today announced the successful completion of
the
previously announced
exclusive license agreement
with Dizal Pharmaceutical Co., Ltd
for
Zegfrovy
(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
commercialise
Zegfrovy
.
Zegfrovy
is 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)
with
EGFR
exon 20 insertion mutations. Patients
with NSCLC with
EGFR
exon 20 insertion mutations experience
a real-world five-year overall survival rate as low as 8%
underscoring the unmet need for new treatment
options.
1
Zegfrovy
is
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
with
EGFR
exon 20 insertion mutation-positive advanced
or metastatic NSCLC. See NCCN Guidelines
®
for detailed
recommendations.
2
A supplemental New Drug Application for approval
of
Zegfrovy
in 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
of
Zegfrovy
in 1st-line NSCLC
with
EGFR
exon 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 in
The
New England Journal of Medicine
.
Zegfrovy
has 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 to
Zegfrovy
in this setting.
Financial considerations
AstraZeneca 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 of
Zegfrovy
.
This 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.
3
Lung
cancer is broadly split into small cell lung cancer or NSCLC, the
latter accounting for 80-85% of cases.
3-4
Approximately
75% of people are diagnosed with advanced NSCLC.
5
Additionally,
about 10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have
EGFR
m NSCLC.
6-8
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. Supplemental New Drug Applications for approval
of
Zegfrovy
in 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
to
Zegfrovy
in
this setting.
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);
Zegfrovy
(sunvozertinib);
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. Bazhenova L, et
al. Comparative clinical outcomes for patients with advanced
NSCLC harboring
EGFR
exon 20 insertion mutations and
common
EGFR
mutations. 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.
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.
AstraZeneca
PLC
Date:
01 September 2026
By: /s/
Matthew Bowden
Name:
Matthew Bowden
Title:
Company Secretary