RCS - Hutchmed China Ltd - NDA Acceptance in China for Fanregratinib

HUTCHMED (China)Announcement

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RNS Number : 9760M  Hutchmed (China) Limited  29 December 2025

Press Release

 

HUTCHMED Announces NDA Acceptance in China with Priority Review Status for
Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma

 

- NDA supported by results from a Phase II registration trial in China -

- Second most common form of liver cancer after hepatocellular carcinoma,
with generally poorer long-term survival in comparison -

Hong Kong, Shanghai & Florham Park, NJ - Monday, December 29, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application
("NDA") for fanregratinib (HMPL-453) for the treatment of adult patients with
advanced, metastatic or unresectable  intrahepatic cholangiocarcinoma ("ICC")
with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who
have previously received systemic therapy has been accepted and granted
priority review by the China National Medical Products Administration
("NMPA").

 

Fanregratinib (HMPL‑453) is a novel, selective, oral inhibitor targeting
FGFR 1/2/3. ICC is a highly aggressive malignancy arising from the
intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver
cancers, and consequently it is the second most common type after
hepatocellular carcinoma. In recent years, the incidence of ICC has continued
to rise, with a 5-year overall survival rate of approximately 9%. 1  (#_edn1)
 Approximately 10-15% of ICC patients globally have tumors harboring FGFR2
fusions or rearrangements. 2  (#_edn2) (, 3  (#_edn3) )

 

This NDA is supported by data from a single-arm, multi-center, open-label,
Phase II registration study in China. The study has met its primary endpoint
of objective response rate (ORR). Results from the secondary endpoints
including progression-free survival (PFS), disease control rate (DCR),
duration of response (DoR) and overall survival (OS) also support the primary
endpoint findings. Full results will be submitted for presentation at an
upcoming scientific conference. Additional details may be found at
clinicaltrials.gov using identifier NCT04353375
(https://clinicaltrials.gov/ct2/show/NCT04353375) .

 

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 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 around the world including 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, including its expectations regarding the
review of a NDA for fanregratinib for the treatment of ICC with the NMPA and
the timing of such review, therapeutic potential of fanregratinib for the
treatment of patients with ICC and the further development of fanregratinib in
this and other indications. 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 fanregratinib for the
treatment of patients with ICC or other indications in China or other
jurisdictions, its potential to gain approvals from regulatory authorities on
an expedited basis or at all, the safety profile of fanregratinib, HUTCHMED's
ability to fund, implement and complete its further clinical development and
commercialization plans for fanregratinib and the timing of these events.
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.

 

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 / Tim Stamper                            +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)
 Brunswick - Zhou Yi                                 +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                     (mailto:HUTCHMED@brunswickgroup.com)

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

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

 Deutsche Numis                                      Joint Broker
 Freddie Barnfield / Jeffrey Wong / Duncan Monteith  +44 20 7260 1000

 

 1  (#_ednref1)   Expert consensus on precision detection of intrahepatic
cholangiocarcinoma (2024 edition). Chin J Clin Med. 2025;32(1):1-18.

 2  (#_ednref2)   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  (#_ednref3)   Nakamura H, Arai Y, Totoki Y, et al. Genomic spectra of
biliary tract cancer. Nat Genet. 2015;47:1003-10.

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