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Hutchison China Meditech Limited
24 August 2020
Press Release
Chi-Med Highlights Clinical Data to be Presented at the Upcoming
ESMO Virtual Congress 2020
Hong Kong, Shanghai, & Florham Park, NJ: Monday, August 24,
2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announces that new and updated analyses on the studies
of surufatinib and fruquintinib will be presented at the upcoming
European Society for Medical Oncology (ESMO) Virtual Congress 2020,
taking place on September 17-21, 2020.
Further details of the presentations are as follows:
SURUFATINIB
Title: Surufatinib (S) for patients (Pts) with advanced pancreatic
neuroendocrine tumors (SANET-p): a randomized, double-blind,
placebo (P)-controlled Phase III trial (NCT02589821)
Lead Author: Jianming Xu, Head of the Department of Gastrointestinal
Oncology, The Fifth Medical Center, General Hospital
of the PLA
Session: Proffered Paper - NETs
Abstract #: 1156O
Date & Time: Sunday, September 20, 2020 2:25 PM CEST
Room: Channel 3
Title: Subgroup analysis by Ki-67 and primary tumor origins
of the randomized, placebo-controlled phase 3 study
of surufatinib in advanced well-differentiated extrapancreatic
neuroendocrine tumors (SANET-ep)
Lead Author: Zhiwei Zhou, Director, Department of Gastric and Pancreatic
Surgery, Sun Yat-sen University Cancer Center
Session: e-Poster Display Session
Abstract #: 1165P
Date available: Thursday, September 17, 2020
FRUQUINTINIB
Title: Phase (Ph) 1/1b Trial of Fruquintinib (Fru) in Patients
(Pts) with Advanced Solid Tumors: Preliminary Results
of the Dose Expansion (Exp) Cohort in Refractory Metastatic
Colorectal Cancer (mCRC)
Lead Author: N. Arvind Dasari, Associate Professor, Department
of Gastrointestinal (GI) Medical Oncology, Division
of Cancer Medicine, The University of Texas MD Anderson
Cancer Center
Session: e-Poster Display Session
Abstract #: 458P
Date available: Thursday, September 17, 2020
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.
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. A
second NDA for surufatinib for the treatment of patients with
advanced pancreatic NET has been submitted to the NMPA. We have
completed a pre-NDA meeting in the U.S. and received scientific
advice in Europe, regarding surufatinib's respective paths to
registration in both geographies. Chi-Med is planning a rolling NDA
submission from late 2020 into early 2021 to the U.S. Food and Drug
Administration (FDA), followed by a marketing authorization
application (MAA) to the European Medicines Agency (EMA) in 2021.
In the U.S., surufatinib was granted Fast Track Designations for
development in pancreatic and non-pancreatic (extra-pancreatic)
NET, and Orphan Drug Designation for pancreatic NET. Additionally,
surufatinib is in several late-stage and proof-of-concept trials in
China, including in combination with immunotherapies, and
proof-of-concept clinical trials in the U.S.
Chi-Med currently retains all rights to surufatinib
worldwide.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of
VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor
angiogenesis. Fruquintinib was designed to improve kinase
selectivity to minimize off-target toxicities, improve tolerability
and provide more consistent target coverage. The generally good
tolerability in patients to date, along with fruquintinib's low
potential for drug-drug interaction based on preclinical
assessment, suggests that it may be highly suitable for
combinations with other anti-cancer therapies.
Fruquintinib was approved for marketing in China by the NMPA in
September 2018 and commercially launched by Eli Lilly and Company
("Lilly") in late November 2018 under the brand name Elunate(R) ,
for the treatment of patients with metastatic colorectal cancer
("CRC"). A Phase III registration study for CRC is being initiated
in the U.S., Europe and Japan. A Phase III registration study is
also ongoing in China for the treatment of patients with gastric
cancer, in combination with paclitaxel. Additionally, fruquintinib
is in several other proof-of-concept trials in China and the U.S.,
including in combination with immunotherapies.
Chi-Med retains all rights to fruquintinib outside of China and
is partnered with Lilly in China. Starting October 1, 2020, Chi-Med
will be responsible, through its commercial team in oncology of
over 320 staff, for the development and execution of all
on-the-ground medical detailing, promotion and local and regional
marketing activities in China for Elunate(R) . Lilly and Chi-Med
will continue to collaborate, as before, in the formulation and
execution of national marketing strategy and events in China for
Elunate(R) .
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
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 nine 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 for the clinical development of
fruquintinib and surufatinib, the further clinical development for
surufatinib and fruquintinib, 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
candidates surufatinib and fruquintinib, including as a combination
therapies, 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 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.
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
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END
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