RCS - Hutchmed China Ltd - Completed Enrollment of Phase II Study

HUTCHMED (China)Announcement

06/03/2025 10:00

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RNS Number : 6194Z  Hutchmed (China) Limited  06 March 2025

Press Release

 

HUTCHMED Announces that it has Completed Enrollment of a Phase II Registration Study of Fanregratinib (HMPL-453) for Intrahepatic Cholangiocarcinoma in China

 

Hong Kong, Shanghai & Florham Park, NJ -  Thursday, March 6, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13)  today announces that it has completed enrollment
of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic
cholangiocarcinoma ("IHCC") patients with fibroblast growth factor receptor
("FGFR")2 fusion/rearrangement.

 

The study is a single-arm, multi-center, open-label, Phase II registration
study to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in
treating advanced IHCC patients with FGFR2 fusion/rearrangement. Primary
endpoint is objective response rate (ORR). Secondary endpoints include
progression-free survival (PFS), disease control rate (DCR), duration of
response (DoR) and overall survival (OS). A total of 87 patients were enrolled
into the registration phase of the study. Additional details may be found at
clinicaltrials.gov using identifier NCT04353375
(https://clinicaltrials.gov/ct2/show/NCT04353375) .

 

The first patient received the first dose in March 2023 and HUTCHMED expects
to announce topline results from the study around the end of 2025. If
favorable, the results could enable a New Drug Application submission to
China's National Medical Products Administration (NMPA).

 

About Fanregratinib

Fanregratinib (HMPL‑453) is a novel, highly selective and potent inhibitor
targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a
driving force in tumor growth, promotion of angiogenesis and resistance to
anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the
drivers of tumor cell proliferation in several solid tumor settings.

 

HUTCHMED currently retain all rights to fanregratinib worldwide.

 

About IHCC with FGFR2 Fusion/Rearrangement

IHCC is one of the subtypes of primary bile duct cancer. In China, an
estimated 61,900 newly diagnosed IHCC occurred in 2015 and the overall IHCC
incidence increased by 9.2% per year between 2006 and 2015. 1  FGFR2 fusion
has been reported to have a prevalence of 10-15% in IHCC patients. 2 (,) 3 

 

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. Since inception it has
focused on bringing drug candidates from in-house discovery to patients around
the world, with its first three medicines marketed in China, the first of
which is also approved in the US, Europe and Japan. For more information,
please visit: www.hutch‑med.com (https://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 US Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect HUTCHMED's current
expectations regarding future events, includ-ing its expectations regarding
the thera-peutic potential of fanregratinib, the further clinical
develop-ment for fanregratinib, its expectations as to whether any studies on
fanregratinib 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 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 fanregratinib, 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 fanregratinib 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 HUTCHMED's filings with the US 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 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                     +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                      (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Alex Shaw                               +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
 Brunswick - Zhou Yi                                  +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                      (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                      Nominated Advisor and Joint Broker
 Atholl Tweedie / Freddy Crossley / Rupert Dearden    +44 20 7886 2500

 HSBC                                                 Joint Broker
 Simon Alexander / Alina Vaskina / Arnav Kapoor       +44 20 7991 8888

 Cavendish                                            Joint Broker
 Geoff Nash / Nigel Birks                             +44 20 7220 0500

 

 1     An L, Zheng R, Zhang S, et al. Hepatocellular carcinoma and
intrahepatic cholangiocarcinoma incidence between 2006 and 2015 in China:
estimates based on data from 188 population-based cancer registries.
Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):45-55.

 2     Arai Y, Totoki Y, Hosoda F, et al. Fibroblast growth factor receptor
2 tyrosine kinase fusions define a unique molecular subtype of
cholangiocarcinoma. Hepatology. 2014;59:1427-34.

 3     Nakamura H, Arai Y, Totoki Y, et al. Genomic spectra of biliary tract
cancer. Nat Genet. 2015;47:1003-10.

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