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2019-08-22

AstraZeneca: Roxadustat approved in China for the treatment of anaemia in non-dialysis-dependent patients with chronic kidn...

China becomes the first country to approve roxadustat for all chronic
kidney disease patients with anaemia

AstraZeneca today announced that its partner FibroGen (China) Medical
Technology Development Co., Ltd. (FibroGen China) has received
marketing authorisation for roxadustat in China for the treatment of
anaemia caused by chronic kidney disease (CKD) in
non-dialysis-dependent (NDD) patients.

This approval, granted by the National Medical Products
Administration, is primarily supported by a Phase III trial in
NDD-CKD patients with anaemia, in which roxadustat demonstrated a
statistically-significant improvement in haemoglobin levels from
baseline averaged over weeks seven to nine of treatment, with a mean
change of 1.9 g/dL compared to -0.4 g/dL with placebo. This data was
published in The New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa1813599) in July 2019.

This marketing authorisation follows the approval of roxadustat in
China in December 2018 for anaemia in CKD patients who are on
dialysis. AstraZeneca and FibroGen China expect to launch roxadustat
in China during the second half of 2019.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"With this approval for roxadustat in China, we are now able to
provide this first-in-class medicine to all patients living with
chronic kidney disease who experience anaemia, regardless of whether
they require dialysis. This is a significant milestone and we look
forward to bringing the medicine to patients later this year."

Anaemia caused by CKD is associated with cardiovascular disease,
hospitalisation, cognitive impairment and reduced quality of life,
and has been shown consistently to increase the risk of death in
patients with CKD.[1] Anaemia becomes increasingly common in patients
with CKD as their disease progresses.[1]

About roxadustat

Roxadustat is a first-in-class, orally-administered small-molecule
currently approved in China for the treatment of patients with
anaemia from CKD on dialysis and not on dialysis. Roxadustat is a
hypoxia-inducible factor prolyl hydroxylase inhibitor that promotes
erythropoiesis by increasing endogenous production of erythropoietin
and improving iron regulation, and overcoming the negative impact of
inflammation on haemoglobin synthesis and red blood cell production
by downregulating hepcidin. Administration of roxadustat has been
shown to induce coordinated erythropoiesis, increasing red blood cell
count while maintaining plasma erythropoietin levels within or near
normal physiologic range, in multiple subpopulations of CKD patients,
including in the presence of inflammation, and without a need for
supplemental intravenous iron.

About the AstraZeneca and FibroGen China collaboration

AstraZeneca and FibroGen China are collaborating on the development
and commercialisation of roxadustat in China. FibroGen China, based
in Beijing, is a wholly-owned subsidiary of FibroGen Inc. that
sponsored the development and registration of roxadustat. FibroGen
China conducted the China Phase III clinical trials and submitted the
New Drug Application for registration of roxadustat to the Chinese
regulatory authorities. Following this approval, AstraZeneca will
manage commercialisation activities in China, and FibroGen China will
manage commercial manufacturing and medical affairs as well as
continued clinical development and regulatory affairs.

About anaemia in CKD in China

Anaemia commonly develops in association with CKD and is linked to
significant morbidity and mortality in both the dialysis and
non-dialysis populations. CKD affects an estimated 120 million
patients in China.[2] Although CKD may occur at any age, it is more
common in aging populations, and its prevalence is increasing. CKD
can be both a cause and a consequence of cardiovascular disease and
is a critical healthcare issue. There is no treatment available that
is curative or has the ability to stop kidney deterioration.

About AstraZeneca in CV, renal and metabolism (CVRM)

CVRM together form one of AstraZeneca's main therapy areas and a key
growth driver for the Company. By following the science to understand
more clearly the underlying links between the heart, kidneys and
pancreas, AstraZeneca is investing in a portfolio of medicines to
protect organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. Our ambition is to modify
or halt the natural course of CVRM diseases and potentially
regenerate organs and restore function, by continuing to deliver
transformative science that improves treatment practices and
cardiovascular health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are used
by millions of patients worldwide. For more information, please visit
astrazeneca.com (http://www.astrazeneca.com/) and follow us on
Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
Matt Kent BioPharmaceuticals +44 203 749 5906
Jennifer Hursit Other +44 203 749 5762
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Malmberg
Hägerstrand
Michele Meixell US +1 302 885 2677

Investor
Relations
Thomas Kudsk +44 203 749 5712
Larsen
Henry Wheeler Oncology +44 203 749 5797
Christer BioPharmaceuticals (CV, metabolism) +44 203 749 5711
Gruvris
Nick Stone BioPharmaceuticals (respiratory, renal) +44 203 749 5716
Josie Afolabi Other medicines +44 203 749 5631
Craig Marks Finance, fixed income +44 7881 615 764
Jennifer Corporate access, retail investors +44 203 749 5824
Kretzmann
US toll-free +1 866 381 72 77

References

1. Babitt JL, Lin HY. Mechanisms of Anemia in CKD. J Am Soc Nephrol
(2012); 23:1631-1634.

2. Zhang L, Wang F, Wang L, et al. Prevalence of chronic kidney
disease in China: a cross-sectional survey. Lancet 2012; 379: 815-22.

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