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Hutchison China Meditech Limited
13 January 2020
Press Release
Chi-Med Initiates a Phase II Trial of Surufatinib in Combination
with Tuoyi in Patients with Advanced Solid Tumors
London: Monday, January 13, 2020: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase II
study in China of surufatinib in combination with Tuoyi
(toripalimab) in patients with advanced solid tumors. This follows
the recent completion of the Phase I dose finding study and
successful establishment of the Phase II combination dosing regimen
for surufatinib and Tuoyi.
This China Phase II clinical study is part of a global
collaboration with Shanghai Junshi Biosciences Co. Ltd. ("Junshi"),
to evaluate surufatinib, Chi-Med's oral angio-immuno kinase
inhibitor, in combination with Tuoyi, Junshi's anti-programmed cell
death protein 1 ("PD-1") monoclonal antibody which was approved by
China's National Medical Products Administration ("NMPA") in
December 2018. The study is designed to test the potential
synergistic anti-tumor effects of the combination's ability to
simultaneously target multiple cell types and signaling pathways in
the tumor microenvironment.
The Phase II study plans to explore multiple solid tumor patient
populations. The primary outcome measures are objective response
rate (ORR) and safety. The secondary outcomes include duration of
response (DoR), progression-free survival ("PFS"), disease control
rate (DCR) and overall survival ("OS"). The lead principal
investigator of the study is Professor Lin Shen, Vice President of
Peking University Hospital and Cancer Institute. Additional details
may be found at clinicaltrials.gov, using identifier
NCT04169672.
Christian Hogg, Chief Executive Officer of Chi-Med, said, "We
are excited to move into Phase II development on the surufatinib
toripalimab combination and look forward to identifying patient
groups that could benefit from this innovative treatment
regimen."
In December 2019, surufatinib was granted Priority Review status
by the Center for Drug Evaluation (CDE) of China's NMPA for its New
Drug Application ("NDA") for the treatment of patients with
advanced non-pancreatic neuroendocrine tumors ("NET").
In November 2019, the NDA for surufatinib for the treatment of
non-pancreatic NET was accepted for review by the NMPA, and the
U.S. Food and Drug Administration granted Orphan Drug designation
to surufatinib for the treatment of pancreatic NET.
About Surufatinib
Surufatinib (previously known as HMPL-012 or sulfatinib) 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.
Surufatinib is in several late-stage and proof-of-concept clinical
trials in China and proof-of-concept clinical trials in the
U.S.
According to Frost & Sullivan, the market for
anti-angiogenesis VEGF/VEGFR inhibitors in China has grown from
US$500 million in 2015 to over US$1.5 billion in 2019 and is
expected to reach US$5 billion by 2026.
Chi-Med currently retains all rights to surufatinib
worldwide.
Non-Pancreatic NET in China: In 2015, we initiated the SANET-ep
study, a Phase III study of surufatinib in advanced neuroendocrine
tumors - extra-pancreatic patients in China for whom there is no
effective therapy. In June 2019, a 198-patient interim analysis was
conducted, leading the independent data monitoring committee to
determine that the study met the pre-defined primary endpoint of
progression-free survival ("PFS") and should be stopped early. The
positive results were highlighted in an oral presentation at the
2019 European Society for Medical Oncology Congress in September
2019. In November 2019, the NDA was accepted for review by the NMPA
(clinicaltrials.gov identifier: NCT02588170) and subsequently
granted Priority Review status.
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 an interim analysis in the first half of
2020 and enrollment to complete in 2020 (clinicaltrials.gov
identifier: NCT02589821).
NET in the U.S. and Europe: We are planning a U.S. registration
study in NET patients based on the encouraging data from the Phase
II and Phase III studies of surufatinib in NET in China
(clinicaltrials.gov identifier: NCT02267967), and the ongoing Phase
II study in the U.S. (clinicaltrials.gov identifier:
NCT02549937).
Biliary tract cancer in China: In March 2019, we initiated a
Phase IIb/III study comparing surufatinib with capecitabine in
patients with advanced biliary tract cancer whose disease
progressed on first-line chemotherapy. The primary endpoint is
overall survival (OS) (clinicaltrials.gov identifier
NCT03873532).
Immunotherapy combinations: In November 2018 and September 2019,
we entered into collaboration agreements to evaluate the safety,
tolerability and efficacy of surufatinib in combination with
anti-PD-1 monoclonal antibodies. This included global
collaborations to evaluate the combination of surufatinib with
Tuoyi, approved in China by Junshi, and with Tyvyt(R) , approved in
China by Innovent Biologics, Inc.
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 490 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies in cancer 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.
Chi-Med is headquartered in Hong Kong and is dual-listed on the
AIM market of the London Stock Exchange and the Nasdaq Global
Select Market. 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 in combination therapy with toripalimab, its
expectations regarding the NDA approval and launch of surufatinib
for the treatment of patients with non-pancreatic NET in China, the
further clinical development of surufatinib in non-pancreatic NET,
pancreatic NET and other indications, its expectations as to
whether clinical studies of surufatinib 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 the sufficiency of its data to support NDA approval of
surufatinib for the treatment of patients with non-pancreatic NET
in China, its potential to gain expeditious approvals for
surufatinib under priority review in China and in other
jurisdictions such as the U.S. and EU, the safety profile of
surufatinib, the potential for surufatinib to become a new standard
of care for non-pancreatic NET patients, its ability to implement
and complete its further clinical development plans for
surufatinib, its potential commercial launch of surufatinib in
China and other jurisdictions and the timing of these events.
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 +852 2121 8200
Annie Cheng, Vice President +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
Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500
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END
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