HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2023
16 Oktober 2023 - 10:30AM
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13)
today announces that new and updated clinical data from several
ongoing studies of fruquintinib, in combination with chemotherapies
and/or immunotherapies, will be presented at the upcoming European
Society for Medical Oncology (“ESMO”) Congress 2023, taking place
on October 20-24, 2023 in Madrid, Spain.
Details of the presentations are as follows:
Abstract title |
Presenter / Lead author |
Presentation details |
SPONSORED STUDY |
|
|
Fruquintinib plus Sintilimab in patients with either
treatment naïve or previously treated advanced gastric or
gastroesophageal junction adenocarcinoma: results from a
multicenter, single-arm phase Ib/II study |
Xiaoli Wei, Harbin Medical University Cancer Hospital, Harbin,
China |
1519PPoster presentation (Oesophagogastric cancer)Monday, October
23, 2023 |
INVESTIGATOR-INITIATED STUDIES |
|
|
First report of the safety/tolerability and preliminary
antitumor activity of fruquintinib plus capecitabine versus
capecitabine as maintenance treatment for metastatic colorectal
cancer: an open-label, randomized phase Ib/II study |
Wenhua Li, Department of Gastrointestinal Medical Oncology, Fudan
University Shanghai Cancer Center, Shanghai, China |
639PPoster presentation (Colorectal cancer)Sunday, October 22,
2023 |
Updated results from the multicenter phase II study of
fruquintinib plus mFOLFOX6/FOLFIRI as first-line therapy in
advanced metastatic colorectal cancer (mCRC) |
Fuxiang Zhou, Department of Radiation and Medical Oncology,
Zhongnan Hospital of Wuhan University, Wuhan, China |
612PPoster presentation (Colorectal cancer)Sunday, October 22,
2023 |
A phase II study to evaluate the efficacy and safety of
fruquintinib combined with tislelizumab and Hepatic artery infusion
chemotherapy (HAIC) for advanced colorectal cancer liver metastases
(CRLM) |
Lu Wang, Liver surgery department, Fudan University Shanghai Cancer
Center, Shanghai, China |
637PPoster presentation (Colorectal cancer)Sunday, October 22,
2023 |
Fruquintinib combined with sintilimab and chemotherapy as
the first-line treatment in advanced naive EGFR- and ALK-negative
non-squamous non-small cell lung cancer (nsq-NSCLC): Updated
results of a phase II trial |
Pei Ma, Department of Oncology, The First Affiliated Hospital of
Nanjing Medical University, Nanjing, Jiangsu, China |
1494PPoster presentation (NSCLC, metastatic)Monday, October 23,
2023 |
About Fruquintinib
Fruquintinib is a selective oral inhibitor of
VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in
inhibiting tumor angiogenesis. Fruquintinib was designed to have
enhanced selectivity that limits off-target kinase activity,
allowing for high drug exposure, sustained target inhibition, and
flexibility for the potential use as part of combination therapy.
Fruquintinib has been shown to be generally well tolerated in
patients to date and is being investigated in combinations with
other anti-cancer therapies.
Fruquintinib was approved for marketing by the
China National Medical Products Administration (NMPA) in September
2018 and commercially launched in China in November 2018 under the
brand name ELUNATE®. A marketing submission to the U.S. Food and
Drug Administration (“FDA”) was granted Priority Review and
assigned a Prescription Drug User Fee Act (PDUFA) goal date of
November 30, 2023. In addition, a submission to the European
Medicines Agency (“EMA”) was validated and accepted for review in
June 2023, and a submission to the Japan Pharmaceuticals and
Medical Devices Agency (“PMDA”) took place in September 2023.
Takeda has the exclusive worldwide license to
further develop, and commercialize, and manufacture fruquintinib
outside of China. Fruquintinib is developed and marketed in China
by HUTCHMED, in partnership with Eli Lilly and Company.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an
innovative, commercial-stage, biopharmaceutical company. It is
committed to the discovery and global development and
commercialization of targeted therapies and immunotherapies for the
treatment of cancer and immunological diseases. It has
approximately 5,000 personnel across all its companies, at the
center of which is a team of about 1,800 in oncology/immunology.
Since inception it has focused on bringing cancer drug candidates
from in-house discovery to patients around the world, with its
first three oncology drugs now approved and marketed in China. For
more information, please visit: www.hutch-med.com or follow us on
LinkedIn.
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 HUTCHMED’s current expectations
regarding future events, including but not limited to its
expectations regarding the approval of a New Drug Application
(“NDA”) for fruquintinib for the treatment of CRC with the FDA, EMA
and the PMDA and the timing of such approvals, the therapeutic
potential of fruquintinib, the further clinical development for
fruquintinib, its expectations as to whether any studies on
fruquintinib 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 timing and outcome of
clinical studies and the sufficiency of clinical data to support
NDA approval of fruquintinib for the treatment of patients with CRC
or other indications in jurisdictions such as China, the U.S., the
E.U. or Japan, its potential to gain approvals from regulatory
authorities on an expedited basis or at all; the efficacy and
safety profile of fruquintinib;, assumptions regarding enrollment
rates and the 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 fruquintinib, including as a combination
therapy, to meet the primary or secondary endpoint of a study, to
obtain regulatory approval in different jurisdictions and to gain
commercial acceptance after obtaining regulatory approval; the
potential market of fruquintinib for a targeted indication; the
sufficiency of funding; and the impact of COVID-19 or other
infectious diseases on general economic, regulatory and political
conditions. In addition, as certain studies rely on the use of
capecitabine, mFOLFOX6/FOLFIRI, tislelizumab or sintilimab as
combination therapeutics, such risks and uncertainties include
assumptions regarding their safety, efficacy, supply and continued
regulatory approval. 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 HUTCHMED’s filings with
the U.S. Securities and Exchange Commission, The Stock Exchange of
Hong Kong Limited and on AIM. HUTCHMED 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.
Medical Information
This press release contains information about
products that may not be available in all countries, or may be
available under different trademarks, for different indications, in
different dosages, or in different strengths. Nothing contained
herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under
development.
CONTACTS
Investor Enquiries |
+852 2121 8200 /
+1 973 306 4490 / ir@hutch-med.com |
|
|
Media Enquiries |
|
Ben Atwell / Alex Shaw, FTI Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) /
HUTCHMED@fticonsulting.com |
Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
|
|
Nominated Advisor |
|
Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon |
+44 (20) 7886 2500 |
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