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2018-12-18

AstraZeneca: Roxadustat approved in China for the treatment of anaemia in chronic kidney disease patients on dialysis

China is the first country to approve roxadustat

AstraZeneca today announced that its partner FibroGen (China) Medical
Technology Development Co., Ltd. (FibroGen China) has now received
formal marketing authorisation from the National Medical Products
Administration (NMPA) for roxadustat, a first-in-class
hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and
new oral treatment for patients with anaemia caused by chronic kidney
disease (CKD) that are on dialysis. The medicine can be prescribed to
patients who use haemodialysis or peritoneal dialysis.

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 mortality risk in
patients with CKD.1 Anaemia becomes increasingly common among
individuals with CKD as their disease progresses, affecting nearly
all patients at the dialysis stage.1

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "Roxadustat is a long-awaited,
first-in-class medicine for patients with anaemia in chronic kidney
disease that are on dialysis. This first approval of roxadustat in
China is a significant step towards achieving our ambition to
transform care in a condition where prevalence in China is
increasing."

Roxadustat is the first approved oral HIF-PHI medicine for patients
with anaemia from CKD. This approval is supported by an open-label,
active-control 26-week Phase III trial in dialysis dependent-CKD (DD
CKD) patients with anaemia who were previously treated with various
forms of a generic erythropoiesis-stimulating agent (ESA). In the
trial, these DD-CKD patients were then randomised to receive either
roxadustat or epoetin alfa, an ESA. Rates of adverse events related
to roxadustat observed in the trial were generally low (<5%), and
mostly of Grade 1-2 severity. The adverse events observed were
consistent with underlying diseases in patients with CKD.

Anaemia commonly develops in association with CKD and is estimated to
affect 120 million patients in China, with an estimated 0.5 million
patients on dialysis who may be suffering from anaemia, a number that
is increasing significantly.2,3

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. AstraZeneca
and FibroGen expect to launch roxadustat in China during the second
half of 2019.

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. Roxadustat is a HIF-PHI 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.

FibroGen, Inc., the originator, and AstraZeneca are collaborating on
the development and commercialisation of roxadustat for the treatment
of anaemia in patients with CKD in the US, China, and other global
markets. FibroGen and Astellas Pharma Inc. are collaborating on the
development and commercialisation of roxadustat for the treatment of
anaemia in patients with CKD in territories including Japan, Europe,
the Commonwealth of Independent States, the Middle East, and South
Africa.

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 FibroGen

FibroGen, Inc., headquartered in San Francisco, California, with
subsidiary offices in Beijing and Shanghai, People's Republic of
China, is a leading biopharmaceutical company discovering and
developing a pipeline of first-in-class therapeutics. The company
applies its pioneering expertise in hypoxia-inducible factor (HIF),
connective tissue growth factor (CTGF) biology, and clinical
development to advance innovative medicines for the treatment of
anemia, fibrotic disease, and cancer. Roxadustat, the company's most
advanced product candidate, is an oral small molecule inhibitor of
HIF prolyl hydroxylase activity, completing worldwide Phase 3
clinical development for the treatment of anemia in chronic kidney
disease (CKD), with a New Drug Application (NDA) now approved by the
National Medical Products Administration (NMPA) in China. Our partner
Astellas submitted a NDA for the treatment of anemia in CKD patients
on dialysis in Japan and currently under review by the
Pharmaceuticals and Medical Devices Agency (PMDA). Roxadustat is in
Phase 3 clinical development in the U.S. and Europe and in Phase 2/3
development in China for anemia associated with myelodysplastic
syndromes (MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody,
is advancing towards Phase 3 clinical development for the treatment
of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is
currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD).
FibroGen is also developing a biosynthetic cornea in China. For more
information, please visit www.fibrogen.com.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and key growth drivers. 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, Cardiovascular, Renal & Metabolism
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
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jennifer Hursit UK/Global +44 203 749 5762
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris Cardiovascular; Metabolism +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
Josie Afolabi Other +44 203 749 5631
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Jennifer Kretzmann Retail Investors +44 203 749 5824
US toll-free +1 866 381 7277

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.

China National Renal Data System (CNRDS

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