TIDMHCM
Hutchison China Meditech Limited
22 April 2020
Press Release
Chi-Med Highlights Presentations of Surufatinib at the Upcoming
AACR Virtual Annual Meetings
London: Wednesday, April 22, 2020: Hutchison China MediTech
Limited ("Chi-Med") (Nasdaq/AIM: HCM) today announces that new and
updated analyses on the ongoing studies of surufatinib will be
presented at the upcoming American Association for Cancer Research
(AACR) Virtual Annual Meeting I, taking place on April 27,
2020.
Further details of the presentations are as follows:
Title: A Phase I Trial of Surufatinib Plus Toripalimab in Patients with Advanced Solid Tumors
Presenter: Yanshuo Cao
Authors: M Lu (1) , Y Cao (1) , J Gong (1) , Y Sun (2) , J Li (1) , L Shen (1) .
(1) Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational
Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing,
China; (2) Department of Pathology, Key Laboratory of Carcinogenesis and Translational Research
(Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China
Session: VPO.CT01
Number: CT142
Link: www.abstractsonline.com/pp8/#!/9045/presentation/10641
Title: Comparison of Pharmacokinetic Profiles and Safety of Surufatinib in Patients from China and
the United States
Presenter: Arvind Dasari
Authors: A Dasari (1) , S Paulson (2) , E Hamilton (3) , J Wang (4) , M Sung (5) , G Falchook (6) ,
C Tucci (7) , K Li (7) , C Chien (7) , J Kauh (7) , M Kania (7) , D Li (8) .
(1) MD Anderson Cancer Center, Houston, TX, USA, (2) Baylor Sammons Cancer Center, Dallas,
TX, MD Anderson Cancer Center, Houston, TX, USA, (3) Sarah Cannon Research Institute/Tennessee
Oncology, Nashville, TN, USA, (4) Florida Cancer Specialists/Sarah Cannon Research Institute,
Sarasota, FL, USA, (5) Mount Sinai Hospital, New York, NY, USA, (6) Sarah Cannon Research
Institute at HealthONE, Denver, Co, USA, (7) Hutchison MediPharma International Inc., Florham
Park, NJ, USA, (8) City of Hope Cancer Center, Duarte, CA, USA.
Session: VPO.CT01
Number: CT115
Link: www.abstractsonline.com/pp8/#!/9045/presentation/10614
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.
Chi-Med currently retains all rights to surufatinib
worldwide.
Neuroendocrine tumors ("NET") in the U.S., Europe and Japan: We
are preparing for regulatory interactions in the U.S., Europe and
Japan to confirm clinical development and path to registration,
based on the encouraging data from the two positive Phase III
studies of surufatinib in NET in China, and the ongoing
multi-cohort Phase Ib study in the U.S. (clinicaltrials.gov
identifier: NCT02549937). In the U.S., surufatinib was granted Fast
Track Designations for development in pancreatic and non-pancreatic
(extra-pancreatic) NET in April 2020, and Orphan Drug Designation
for pancreatic NET in November 2019.
Non-pancreatic neuroendocrine tumors in China : In November
2019, a New Drug Application ("NDA") for surufatinib for the
treatment of patients with advanced non-pancreatic NET was accepted
for review by the China National Medical Products Administration
(NMPA) and granted Priority Review status in December 2019. The NDA
is supported by data from the successful SANET-ep study, a Phase
III study of s urufatinib in a dvanced n euro e ndocrine t umors -
e xtra- p ancreatic patients in China for whom there is no
effective therapy. A 198-patient interim analysis was conducted in
June 2019, leading the Independent Data Monitoring Committee
("IDMC") to determine that the study met the pre-defined primary
endpoint of progression-free survival ("PFS") and should be stopped
early. The positive results of this trial were highlighted in an
oral presentation at the 2019 European Society for Medical Oncology
Congress (clinicaltrials.gov identifier: NCT02588170).
Pancreatic neuroendocrine tumors 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.
A second NDA for surufatinib for the treatment of patients with
advanced pancreatic NET is being prepared for submission, following
an interim analysis review conducted in January 2020 by the IDMC
that recommended that registrational study be terminated early as
the pre-defined primary endpoint of PFS had already been met
(clinicaltrials.gov identifier: NCT02589821). Study results will be
submitted for presentation at an upcoming scientific
conference.
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-programmed cell death protein 1 (PD-1) monoclonal antibodies.
This included global collaborations to evaluate the combination of
surufatinib with Tuoyi (R) , approved in China by Shanghai Junshi
Biosciences Co. Ltd, and with Tyvyt(R) , approved in China by
Innovent Biologics, Inc.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical
company committed, over the past twenty years, to the discovery and
global development of targeted therapies and immunotherapies for
the treatment of cancer and immunological diseases. It has a
portfolio of eight cancer drug candidates currently in clinical
studies around the world and extensive commercial infrastructure in
its home market of China. 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 regarding the therapeutic
potential of surufatinib for the treatment of patients with NET,
the further clinical development of surufatinib in this 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 NET in China, its potential to gain expeditious
approvals for surufatinib in other jurisdictions such as the U.S.,
E.U. or Japan, the safety profile of surufatinib, the potential for
surufatinib to become a new standard of care for 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
Media Enquiries
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / 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
Authority to act as a Primary Information Provider in the United
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of this information may apply. For further information, please
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END
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