TIDMHCM
Hutchmed (China) Limited
16 October 2023
Press Release
HUTCHMED Highlights Clinical Data to be Presented at ESMO
Congress 2023
Hong Kong, Shanghai & Florham Park, NJ - Monday, October 16,
2023: 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 Presentation
author details
======================================== ========================= ====================
SPONSORED STUDY
Fruquintinib plus Sintilimab in Xiaoli Wei, Harbin 1519P
patients with either treatment Medical University Poster presentation
naïve or previously treated Cancer Hospital, (Oesophagogastric
advanced gastric or gastroesophageal Harbin, China cancer)
junction adenocarcinoma: results Monday, October
from a multicenter, single-arm 23, 2023
phase Ib/II study
======================================== ========================= ====================
INVESTIGATOR-INITIATED STUDIES
======================================== ========================= ====================
First report of the safety/tolerability Wenhua Li, Department 639P
and preliminary antitumor activity of Gastrointestinal Poster presentation
of fruquintinib plus capecitabine Medical Oncology, (Colorectal cancer)
versus capecitabine as maintenance Fudan University Sunday, October
treatment for metastatic colorectal Shanghai Cancer Center, 22, 2023
cancer: an open-label, randomized Shanghai, China
phase Ib/II study
======================================== ========================= ====================
Updated results from the multicenter Fuxiang Zhou, Department 612P
phase II study of fruquintinib of Radiation and Poster presentation
plus mFOLFOX6/FOLFIRI as first-line Medical Oncology, (Colorectal cancer)
therapy in advanced metastatic Zhongnan Hospital Sunday, October
colorectal cancer (mCRC) of Wuhan University, 22, 2023
Wuhan, China
======================================== ========================= ====================
A phase II study to evaluate the Lu Wang, Liver surgery 637P
efficacy and safety of fruquintinib department, Fudan Poster presentation
combined with tislelizumab and University Shanghai (Colorectal cancer)
Hepatic artery infusion chemotherapy Cancer Center, Shanghai, Sunday, October
(HAIC) for advanced colorectal China 22, 2023
cancer liver metastases (CRLM)
======================================== ========================= ====================
Fruquintinib combined with sintilimab Pei Ma, Department 1494P
and chemotherapy as the first-line of Oncology, The Poster presentation
treatment in advanced naive EGFR- First Affiliated (NSCLC, metastatic)
and ALK-negative non-squamous non-small Hospital of Nanjing Monday, October
cell lung cancer (nsq-NSCLC): Updated Medical University, 23, 2023
results of a phase II trial Nanjing, Jiangsu,
China
======================================== ========================= ====================
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(R) . 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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