TIDMHCM
Hutchison China Meditech Limited
29 March 2019
Press Release
Chi-Med Initiates a Phase IIb/III Trial of Surufatinib in
Patients with Unresectable or Metastatic Biliary Tract Cancer in
China
London: Friday, March 29, 2019: Hutchison China MediTech Limited
("Chi-Med") (AIM/Nasdaq: HCM) has initiated a registration-enabling
Phase IIb/III study comparing surufatinib (HMPL-012 or sulfatinib)
with capecitabine in patients with advanced biliary tract cancer
("BTC") whose disease progressed on first-line chemotherapy. This
major unmet medical need is a heterogeneous group of rare
malignancies arising from the biliary tract epithelia and the
gallbladder. The first patient was dosed on March 22, 2019 in
China.
The study is a randomized, open-label, active-control,
multi-center, study investigating the effects of surufatinib, an
oral small molecule angio-immuno kinase inhibitor that can
simultaneously block tumor angiogenesis and immune evasion, versus
the chemotherapy agent capecitabine, as a second-line therapy in
patients with unresectable or metastatic BTC. The primary endpoint
is overall survival (OS). Secondary outcomes include measures of
tumor control such as progression free survival ("PFS"), objective
response rate (ORR), disease control rate (DCR), and duration of
response (DOR), quality of life, tumor biomarkers, and safety. The
lead investigator of the study is Professor Jianming Xu of the
Department of Gastrointestinal Oncology, the Fifth Medical Center,
General Hospital of the People's Liberation Army. Additional
details may be found at clinicaltrials.gov, using identifier
NCT03873532.
This study complements a Phase Ib/II proof-of-concept study of
surufatinib in China (clinicaltrials.gov identifier: NCT02966821)
in BTC as well as a Phase Ib study in the US enrolling patients
with BTC and pancreatic neuroendocrine tumors ("NET")
(clinicaltrials.gov identifier: NCT02549937). Results of the Phase
Ib/II proof-of-concept BTC study is expected to be submitted for
publication in 2019.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptor (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. Its unique dual mechanism of action may be
very suitable for possible combinations with other immunotherapies.
In addition to the BTC studies, surufatinib is in proof-of-concept
clinical trials in the U.S. and several proof-of-concept and
late-stage clinical trials in China.
Pancreatic NET in China: In 2016, we initiated the SANET-p
study, which is a pivotal Phase III study in patients with low- or
intermediate-grade, advanced pancreatic NET in China. The primary
endpoint is PFS. We expect to deliver an interim analysis in late
2019 and complete enrollment in 2020 (clinicaltrials.gov
identifier: NCT02589821).
Non-pancreatic NET in China: In December 2015, we initiated the
SANET-ep study, which is a pivotal Phase III study in patients with
low or intermediate grade advanced non-pancreatic NET in China. The
primary endpoint is PFS. We expect to deliver an interim analysis
in mid-2019 and complete enrollment in 2020. (clinicaltrials.gov
identifier: NCT02588170).
Pancreatic NET in the U.S. and Europe: The encouraging data from
the Phase II study of surufatinib in pancreatic NET in China
(clinicaltrials.gov identifier: NCT02267967), and the ongoing Phase
Ib study in the U.S., have led us to decide to proceed with
planning a registration study in pancreatic NET patients.
Immunotherapy combinations: In November 2018, we entered into
two collaboration agreements to evaluate the safety, tolerability
and efficacy of surufatinib in combination with checkpoint
inhibitors. These include a global collaboration to evaluate the
combination of surufatinib with Tuoyi(R) (toripalimab, JS001), a
PD-1 monoclonal antibody approved in China in late 2018 by Shanghai
Junshi Biosciences Co. Ltd. and a collaboration in China to
evaluate the combination of surufatinib with HX008, a PD-1
monoclonal antibody being developed by Taizhou Hanzhong
Pharmaceuticals, Inc.. Safety run-in studies are currently being
planned/underway to establish the safe and effective dose regimens
for the surufatinib combinations with both Tuoyi(R) and HX008.
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 420 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies 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, plans to initiate clinical studies for surufatinib,
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. 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 drug
candidate surufatinib, including as a combination therapy, 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 for a targeted indication and the sufficiency of
funding. In addition, as certain studies rely on the use of
Tuoyi(R) and HX008 as combination therapeutics with surufatinib,
such risks and uncertainties include assumptions regarding the
safety, efficacy, supply and continued regulatory approval for
Tuoyi(R) and HX008. 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
Annie Cheng, Vice President, Corporate Finance & Development +1 (973) 567 3786
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 / Atholl Tweedie, 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
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contact rns@lseg.com or visit www.rns.com.
END
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