Market Overview

Chi-Med and AstraZeneca Initiate SAVOIR, a Global Phase III Trial of Savolitinib in Papillary Renal Cell Carcinoma


Hutchison China MediTech Limited ("Chi-Med") (NASDAQ:HCM) and
AstraZeneca PLC ("AstraZeneca") (NYSE:AZN) today announce that
they have initiated a global pivotal Phase III, open-label, randomized
multi-center registration study of the highly selective inhibitor of
c-MET receptor tyrosine kinase, savolitinib, in c-MET-driven papillary
renal cell carcinoma ("PRCC"). This is the first pivotal study ever
conducted in c-MET-driven PRCC and the first molecularly selected trial
in renal cell carcinoma ("RCC").

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"The launch of the SAVOIR trial, designed to support product
registration in the U.S. and Europe, continues to advance our strategy
to deliver innovative medicines to major markets worldwide," said
Christian Hogg, Chief Executive Officer of Chi-Med. "Based on the
results of our Phase II study, we believe savolitinib has the potential
to bring meaningful clinical benefit to patients with c-MET-driven PRCC.
We also expect to further understand the correlations between c-MET
alterations and patient outcomes through epidemiological analyses using
our newly developed companion diagnostic assay."

Susan Galbraith, SVP IMED Oncology, AstraZeneca commented that "It is
exciting to achieve this milestone in savolitinib's development. The
data building across our early development studies are encouraging,
that savolitinib has the potential to be an important treatment option
for c-MET driven cancers including kidney, lung and gastric cancers."

The initiation of this Phase III trial has triggered a US$5 million
milestone payment to Hutchison MediPharma Limited (a 99.8% subsidiary of
Chi-Med) from AstraZeneca under the terms of the license and
collaboration agreement signed between them in 2011 (as amended).

In addition to SAVOIR, Chi-Med and AstraZeneca are conducting a number
of Phase Ib and II studies of savolitinib in kidney cancer, lung cancer
and gastric cancer. These studies involve savolitinib as a monotherapy
or in combination with other targeted therapy, such as Tagrisso®
(osimertinib) or Iressa® (gefitinib). Additional studies
combining with Imfinzi® (durvalumab) and Taxotere® (docetaxel)
are also in progress.


SAVOIR is a global Phase III, open-label, randomized, controlled trial
evaluating the efficacy and safety of savolitinib, compared with
sunitinib, in patients with c-MET-driven, unresectable, locally advanced
or metastatic PRCC. Approximately 180 patients will be randomized at 50
to 75 sites across five to ten countries. c-MET status is confirmed by
the novel targeted next-generation sequencing (NGS) assay developed for
savolitinib. Patients will be randomized in a 1:1 ratio to receive
either continuous treatment with savolitinib 600 mg (400 mg if <50 kg)
orally, once daily, or intermittent treatment with sunitinib 50 mg
orally once daily (4 weeks on/2 weeks off), on a 6-week cycle.

The primary objective is to evaluate the primary efficacy endpoint
progression free survival ("PFS") of savolitinib as compared with
sunitinib. Secondary endpoints include overall survival, objective
response rate ("ORR"), duration of response, best percentage change in
tumor size, disease control rate, and safety and tolerability. The
impact of savolitinib compared with sunitinib on disease symptoms and
quality of life, along with the pharmacokinetics of savolitinib will
also be assessed. Additional details about this study may be found at, using identifier NCT03091192.

About Savolitinib

Savolitinib (AZD6094/HMPL-504) is a potential first-in-class selective
inhibitor of c-MET (also known as mesenchymal epithelial transition
factor) receptor tyrosine kinase, an enzyme which has been shown to
function abnormally in many types of solid tumors. It was developed as a
potent and highly selective oral inhibitor specifically designed to
address issues observed in the clinic with other selective c-MET
inhibitors, such as renal toxicity.

Savolitinib was discovered by Chi-Med and is being developed in
collaboration with AstraZeneca. Savolitinib is currently being studied
in multiple tumor types worldwide including kidney, lung and gastric
cancers, both as a monotherapy or in combination with other targeted and
immunotherapy agents.

About c-MET-Driven PRCC

Worldwide, about 366,000 new patients are diagnosed with kidney cancer
annually. RCC accounts for approximately 80-85% of kidney cancer and has
several histological sub-types with different genetic and biochemical
characteristics. PRCC is the most common of the non-clear cell renal
carcinomas accounting for 10-15% of RCC. However, the biology and
molecular characteristics of PRCC are different from those of clear cell
RCC ("ccRCC"). Multiple studies indicate that PRCC is c-MET-driven in
40-70% of patients.

There are no therapies approved for patients with PRCC, who currently
receive treatments approved for RCC such as sunitinib. These RCC agents
were mostly approved on the basis of studies where the majority of
subjects were ccRCC patients and where the benefits to the PRCC minority
were more modest. Currently the National Comprehensive Cancer Network
Guidelines advise PRCC patients to enter clinical trials.

About Savolitinib in PRCC

In February 2017, the results of a global Phase II multicenter study in
advanced PRCC was presented at the 2017 American Society of Clinical
Oncology Genitourinary Cancers Symposium, which indicated a clear
efficacy signal with savolitinib monotherapy in c-MET-driven patients.
Median PFS of 6.2 months in c-MET-driven patients as compared with 1.4
months (p<0.0001) in c-MET-independent patients. ORR was 18.2% in
c-MET-driven patients vs. 0% (p=0.002) in c-MET independent patients. An
encouraging durable response and safety profile were reported in
savolitinib treated patients. Further details are available at

Studies of c-MET-driven disease in gastric cancer and lung cancer
suggest that c-MET amplification and/or overexpression can be a negative
prognostic for disease progression. Over the course of 2017, Chi-Med and
AstraZeneca are also conducting a comprehensive molecular epidemiology
study of approximately 300 PRCC patient samples to further understand
the correlations between c-MET alterations and patient outcomes,
including any predictive biomarkers.

About Chi-Med

Chi-Med is an innovative biopharmaceutical company which researches,
develops, manufactures and sells pharmaceuticals and healthcare
products. Its Innovation Platform, Hutchison MediPharma Limited, focuses
on discovering and developing innovative therapeutics in oncology and
autoimmune diseases for the global market. Its Commercial Platform
manufactures, markets, and distributes prescription drugs and consumer
health products in China.

Chi-Med is majority owned by the multinational conglomerate CK Hutchison
Holdings Limited (SEHK: 0001). For more information, please visit:

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly
growing portfolio of new medicines that has the potential to transform
patients' lives and the Company's future. With at least 6 new medicines
to be launched between 2014 and 2020 and a broad pipeline of small
molecules and biologics in development, we are committed to advance new
oncology as one of AstraZeneca's six Growth Platforms focused on lung,
ovarian, breast and blood cancers. In addition to our core capabilities,
we actively pursue innovative partnerships and investments that
accelerate the delivery of our strategy, as illustrated by our
investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms – immuno-oncology,
the genetic drivers of cancer and resistance, DNA damage response and
antibody drug conjugates – and by championing the development of
personalized combinations, AstraZeneca has the vision to redefine cancer
treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in three
main therapy areas – oncology, cardiovascular & metabolic diseases and
respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. For more information, please visit
and follow us on Twitter @AstraZeneca.

Forward-Looking Statements

This announcement contains forward-looking statements within the
meaning of the "safe harbor" provisions of the U.S.
Securities Litigation Reform Act of 1995.
These forward-looking
statements reflect Chi-Med's current expectations regarding future
events, including its expectations for the clinical development of
savolitinib, plans to initiate clinical studies for savolitinib, its
expectations as to whether such studies would meet their primary or
secondary endpoints, and its expectations as to the timing of the
completion and the release of results from such studies.
statements involve risks and uncertainties.
Such risks and
uncertainties include, among other things, assumptions regarding
enrollment rates, timing and availability of subjects meeting a study's
inclusion and exclusion criteria, changes to clinical protocols or
regulatory requirements, unexpected adverse events or safety issues, the
ability of drug candidate savolitinib to meet the primary or secondary
endpoint of a study, to obtain regulatory approval in different
jurisdictions, to gain commercial acceptance after obtaining regulatory
approval, the potential market of savolitinib for a targeted indication
and the sufficiency of funding.
Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
further discussion of these and other risks, see Chi-Med's filings with
the U.S.
Securities and Exchange Commission and on AIM. Chi-Med
undertakes no obligation to update or revise the information contained
in this announcement, whether as a result of new information, future
events or circumstances or otherwise.

Inside Information

This announcement contains inside information for the purposes of
Article 7 of Regulation (EU) No 596/2014.

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