TIDMHCM
Hutchison China Meditech Limited
29 November 2018
Press Release
Chi-Med Enters into Multiple Collaborations to Evaluate
Combinations of
Surufatinib and Fruquintinib with PD-1 Checkpoint Inhibitors
London: Thursday, November 29, 2018: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) entered into four
collaboration agreements to evaluate the safety, tolerability and
efficacy of Chi-Med's surufatinib (HMPL-012 or sulfatinib) and
fruquintinib in combination with checkpoint inhibitors. It is an
important part of Chi-Med's strategy to explore the potential
synergies of its drug candidates in combination with other
anti-cancer treatments. These four new immunotherapy collaborations
add to our ongoing studies combining savolitinib, Chi-Med's highly
selective c-Met inhibitor, with AstraZeneca PLC's checkpoint
inhibitor, durvalumab (Imfinzi(R) ).
Today, Chi-Med is announcing the first steps to develop its
vascular endothelial growth factor receptor ("VEGFR") inhibitors,
surufatinib and fruquintinib, in combination with various
programmed cell death protein-1 ("PD-1") monoclonal antibodies in
several solid tumor settings:
-- A global collaboration to evaluate the combination of
surufatinib with toripalimab (JS001), a PD-1 monoclonal antibody
being developed by Shanghai Junshi Biosciences Co. Ltd.;
-- A global collaboration to evaluate the combination of
fruquintinib with sintilimab (IBI308), a PD-1 monoclonal antibody
being developed by Innovent Biologics (Suzhou) Co. Ltd.;
-- A collaboration in China to evaluate the combination of
surufatinib with HX008, a PD-1 monoclonal antibody being developed
by Taizhou Hanzhong Pharmaceuticals, Inc.; and
-- A collaboration in China to evaluate the combination of
fruquintinib with genolimzumab (GB226), a PD-1 monoclonal antibody
being developed by Genor Biopharma Co. Ltd.
The global market for angiogenesis inhibitors was over US$18
billion in 2017, based on their use in around 30 different tumor
settings. Each of the agreements announced today will pursue
different initial indications within the field of solid tumors.
"Recent innovations in solid tumor drugs have focused on
targeted therapies and immunotherapies which, as monotherapies,
have both provided improved patients outcomes," said Christian
Hogg, Chief Executive Officer of Chi-Med. "We believe that the
future of oncology treatments increasingly lies in combining
therapies, utilizing multiple mechanisms of action ("MOA") to
confront tumors. Our unique next-generation anti-angiogenesis VEGFR
inhibitors, with high selectivity and tolerability, make them ideal
candidates for such combinations with immunotherapy agents such as
PD-1/L1 monoclonal antibodies to prolong and expand the benefits of
these therapies to more patients."
Chi-Med's proof-of-concept studies have already demonstrated the
benefits of combinations with other kinase inhibitors or with
chemotherapy.
Surufatinib (HMPL-012 or sulfatinib) is a novel, oral
angio-immuno kinase inhibitor that inhibits VEGFR and fibroblast
growth factor receptor (FGFR) which both inhibit angiogenesis, and
colony stimulating factor-1 receptor (CSF-1R) which regulates
tumor-associated macrophages, promoting the body's immune response
against tumor cells. This dual angiogenesis-checkpoint inhibitor's
MOA may be very suitable for combination use with other
immunotherapies. Surufatinib, as a monotherapy, is in late-stage
clinical trials in China and began proof-of-concept clinical trials
in the United States in July 2018.
Fruquintinib is a highly selective and potent oral inhibitor of
VEGFR. Its unique kinase selectivity has been shown to reduce
off-target toxicity thereby allowing possible use in combination
with other agents. It was first approved for colorectal cancer in
China in September 2018. It is in several late-stage clinical
trials for lung and gastric cancer, including in combination with
chemotherapy such as paclitaxel (Taxol(R) ) and other kinase
inhibitors such as gefitinib (Iressa(R) ), and is in a Phase I
clinical trial in the United States.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical
company which researches, develops, manufactures and markets
pharmaceutical products. Its Innovation Platform, Hutchison
MediPharma, has about 400 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
in oncology and autoimmune diseases. It has a portfolio of eight
cancer drug candidates currently in clinical studies around the
world. Chi-Med's Commercial Platform manufactures, markets, and
distributes prescription drugs and consumer health products,
covering an extensive network of hospitals across China.
Dual-listed on the AIM market of the London Stock Exchange and
the Nasdaq Global Select Market, Chi-Med is headquartered in Hong
Kong and majority owned by the multinational conglomerate CK
Hutchison Holdings Limited (SEHK: 1). For more information, please
visit: www.chi-med.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
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
surufatinib and fruquintinib including as combination therapy with
toripalimab, sintilimab, HX008 or genolimzumab; plans to initiate
clinical studies for surufatinib and fruquintinib including as a
combination therapy with toripalimab, sintilimab, HX008 or
genolimzumab; its expectations as to whether such studies would
meet their primary or secondary endpoints; and its expectations as
to the timing of the enrollment completion and the release of
results from such studies. Forward-looking 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
surufatinib and fruquintinib including as a combination therapy
with toripalimab, sintilimab, HX008 or genolimzumab 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
surufatinib and fruquintinib including as a combination therapy
with toripalimab, sintilimab, HX008 or genolimzumab for a targeted
indication and the sufficiency of funding. In particular, as
certain studies rely on the use of toripalimab, sintilimab, HX008
or genolimzumab as a combination therapeutic with surufatinib and
fruquintinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and regulatory approval of
toripalimab, sintilimab, HX008 or genolimzumab. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. For 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 press release, whether as a
result of new information, future events or circumstances or
otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President, Corporate Finance & Development +852 2121 8200
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
Media Enquiries
UK & Europe - Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
- Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China - Sam Shen, Edelman +86 136 7179 1029 (Mobile)
sam.shen@edelman.com
Nominated Advisor
Richard Gray / Andrew Potts, Panmure Gordon (UK) Limited +44 (20) 7886 2500
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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