RCS - Hutchmed China Ltd - China NDA Acceptance-Savolitinib in Gastric Cancer

HUTCHMED (China)Announcement

30/12/2025 10:00

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RNS Number : 1317N  Hutchmed (China) Limited  30 December 2025

Press Release

 

HUTCHMED Announces NDA Acceptance in China with Priority Review Status for
Savolitinib for the treatment of Gastric Cancer Patients with MET
Amplification

 

- NDA supported by positive Phase II registration study data in Chinese
patients; follows Breakthrough Therapy Designation granted in 2023 -

- Savolitinib has the potential to become the first selective MET inhibitor
in China for MET-amplified gastric cancer -

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, December 30, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application
("NDA") for savolitinib for the treatment of locally advanced or metastatic
gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients
with MET amplification who have failed at least two prior systemic
treatments has been accepted and granted priority review by the China National
Medical Products Administration ("NMPA").

 

This NDA is supported by data from a single-arm, multi-center, open-label,
Phase II registration study of savolitinib in gastric cancer patients
with MET amplification in China. The study has met its primary endpoint of
objective response rate (ORR) by the Independent Review Committee (IRC)
(RECIST 1.1). Additional details may be found at clinicaltrials.gov using
identifier NCT04923932 (https://clinicaltrials.gov/ct2/show/NCT04923932) .

 

Gastric cancer remains one of the most common cancers and leading causes of
cancer death in China. MET-driven gastric cancer has a very poor
prognosis. 1  (#_edn1) It is estimated that MET amplification accounts for
approximately 4-6% of gastric cancer patients. 2  (#_edn2) (, 3  (#_edn3) )
(https://www.hutch-med.com/hutchmed-completes-patient-enrollment-of-a-phase-ii-registration-study-of-savolitinib-in-gastric-cancer-in-china/#_edn3)
 The annual incidence of MET amplification gastric cancer is estimated to
be approximately 18,000 in China. 4  (#_edn4)

 

The NMPA has granted Breakthrough Therapy Designation to savolitinib for this
potential indication in 2023. The NMPA granted this designation to this new
treatment that could target a serious condition where clinical evidence
demonstrates substantial advantages over existing therapies.

 

About Savolitinib

Savolitinib is an oral, potent, and highly selective MET tyrosine kinase
inhibitor (TKI) being jointly developed by AstraZeneca and HUTCHMED and
commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an
essential role in normal cell development. 5  (#_edn5)  Savolitinib blocks
atypical activation of the MET receptor tyrosine kinase pathway that occurs
because of mutations (such as exon 14 skipping alterations or other point
mutations), gene amplification or protein overexpression.

 

Savolitinib is approved in China and is marketed under the brand name
ORPATHYS(®) by our partner, AstraZeneca, representing the first selective
MET inhibitor approved in China. It has been included
(https://www.hutch-med.com/orpathys-nrdl-inclusion/)  in the National
Reimbursement Drug List of China (NRDL) since March 2023.

 

It is currently under clinical development for multiple tumor types, including
lung, kidney, and gastric cancers as a single treatment and in combination
with other medicines.

 

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 savolitinib for the treatment of gastric cancer with the
NMPA and the timing of such review, therapeutic potential of savolitinib for
the treatment of patients with gastric cancer and the further development of
savolitinib 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 savolitinib for
the treatment of patients with gastric cancer 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
savolitinib, HUTCHMED and/or its partner's ability to fund, implement and
complete its further clinical development and commercialization plans for
savolitinib 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.

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 / 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)   Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase
receptor expression and amplification as prognostic biomarkers of survival in
gastroesophageal adenocarcinoma. Cancer. 2017;123(6):1061-1070.
doi:10.1002/cncr.30437

 2  (#_ednref2)   Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides
Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY
Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405.
doi:10.1158/2159-8290.CD-19-044

 3  (#_ednref3)   Van Cutsem E, Karaszewska B, Kang YK, et al. A Multicenter
Phase II Study of AMG 337 in Patients with MET-Amplified
Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma and Other
MET-Amplified Solid Tumors. Clin Cancer Res. 2019;25(8):2414-2423.
doi:10.1158/1078-0432.CCR-18-1337

 4  (#_ednref4)   Global Cancer Observatory. China Fact
Sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf)
. Accessed April 7, 2025.

 5  (#_ednref5)   Uchikawa E, et al. Structural basis of the activation of
c-MET receptor. Nat Commun. 2021;12(4074).

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