RCS - Hutchmed China Ltd - Clinical Data to be Presented at ESMO 2023

HUTCHMED (China)Announcement

16/10/2023 09:30

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RNS Number : 2177Q  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 (https://www.hutch-med.com/) ")
(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          Xiaoli Wei, Harbin Medical University Cancer Hospital, Harbin, China           1519P
 previously treated advanced gastric or gastroesophageal junction
Poster presentation (Oesophagogastric cancer)
 adenocarcinoma: results from a multicenter, single-arm phase Ib/II study
Monday, October 23, 2023
 INVESTIGATOR-INITIATED STUDIES
 First report of the safety/tolerability and preliminary antitumor activity of    Wenhua Li, Department of Gastrointestinal Medical Oncology, Fudan University   639P
 fruquintinib plus capecitabine versus capecitabine as maintenance treatment      Shanghai Cancer Center, Shanghai, China
Poster presentation (Colorectal cancer)
 for metastatic colorectal cancer: an open-label, randomized phase Ib/II study
Sunday, October 22, 2023
 Updated results from the multicenter phase II study of fruquintinib plus         Fuxiang Zhou, Department of Radiation and Medical Oncology, Zhongnan Hospital  612P
 mFOLFOX6/FOLFIRI as first-line therapy in advanced metastatic colorectal         of Wuhan University, Wuhan, China
Poster presentation (Colorectal cancer)
 cancer (mCRC)
Sunday, October 22, 2023
 A phase II study to evaluate the efficacy and safety of fruquintinib combined    Lu Wang, Liver surgery department, Fudan University Shanghai Cancer Center,    637P
 with tislelizumab and Hepatic artery infusion chemotherapy (HAIC) for advanced   Shanghai, China
Poster presentation (Colorectal cancer)
 colorectal cancer liver metastases (CRLM)
Sunday, October 22, 2023
 Fruquintinib combined with sintilimab and chemotherapy as the first-line         Pei Ma, Department of Oncology, The First Affiliated Hospital of Nanjing       1494P
 treatment in advanced naive EGFR- and ALK-negative non-squamous non-small cell   Medical University, Nanjing, Jiangsu, China
Poster presentation (NSCLC, metastatic)
 lung cancer (nsq-NSCLC): Updated results of a phase II trial
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 (http://www.hutch-med.com/)
or follow us on LinkedIn (https://www.linkedin.com/company/hutchmed/) .

 

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
                                                                   (mailto: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
                                                                   (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                   (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon   +44 (20) 7886 2500

 

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