RCS - Hutchmed China Ltd - Surufatinib + Camrelizumab PDAC Phase 3 initiation

HUTCHMED (China)Announcement

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RNS Number : 4785N  Hutchmed (China) Limited  05 January 2026

Press Release

 

HUTCHMED Initiates Phase III Stage of the Ongoing Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, January 5, 2026:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the Phase III
part of the Phase II/III trial to evaluate the efficacy of the combination of
surufatinib, camrelizumab, nab-paclitaxel and gemcitabine as a first-line
treatment for patients with metastatic pancreatic ductal adenocarcinoma
("PDAC") in China. The first patient received the first dose on December 30,
2025.

 

PDAC is a highly aggressive form of cancer, representing over 90% of
pancreatic cancer cases. Globally, an estimated 511,000 people were diagnosed
with pancreatic cancer, leading to approximately 467,000 deaths in 2022, with
an average five-year survival rate of less than 10%. In China, an estimated
119,000 people were diagnosed with pancreatic cancer, causing approximately
106,000 deaths in 2022. 1  Treatments such as chemotherapy, surgery and
radiation are commonly employed, but have not shown significant improvement in
patient outcomes. Under 20% of metastatic pancreatic cancer patients survive
for more than a year. (( 2 ))

 

The trial is a multicenter, randomized, open-label, active-controlled Phase
II/III study to evaluate the efficacy and safety of surufatinib combined with
camrelizumab, nab-paclitaxel and gemcitabine ("S+C+AG") versus nab-paclitaxel
plus gemcitabine ("AG") in adults with metastatic pancreatic cancer who have
not previously received systemic anti-tumor therapy. A total of 62 patients
were enrolled in the Phase II part, with plans to enroll approximately 400
additional patients in the Phase III part. The primary endpoint for the Phase
III part is overall survival (OS). Secondary endpoints include
progression-free survival ("PFS"), objective response rate ("ORR"), duration
of response (DoR), disease control rate ("DCR"), quality of life and safety.
Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan
Hospital and Professor Jihui Hao of Tianjin Medical University Cancer
Institute and Hospital are the leading principal investigators of this study.
Additional details may be found at clinicaltrials.gov, using
identifier NCT06361888 (https://clinicaltrials.gov/study/NCT06361888) .

 

Results from the Phase II part were recently presented at the 2025 European
Society for Medical Oncology (ESMO) Asia Congress
(https://cslide.ctimeetingtech.com/asia2025/attendee/confcal/show/session/101)
. 3  As of the data cut-off of July 24, 2025, the median PFS follow-up
duration was 8.15 months. The S+C+AG regimen demonstrated a median PFS of 7.20
months compared to 5.52 months for the AG arm (stratified hazard ratio  HR 
0.499, log-rank p=0.0407), representing a 50.1% reduction in the risk of
progression or death. Consistent benefits were observed across other key
efficacy endpoints, including ORR (67.7% vs 41.9%, p=0.0430) and DCR (93.5% vs
71.0%, p=0.0149). Although overall survival data were immature at the time of
analysis, a favorable trend was observed (not reached vs 8.48 months,
unstratified HR 0.555), with 9 events in the S+C+AG arm (N=31) and 15 events
in the AG arm (N=31). The safety profile was manageable. Treatment-emergent
adverse events (TEAEs) of grade 3 or above occurred in 80.6% of patients in
the S+C+AG arm compared to 61.3% in the AG arm.

 

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively
inhibits the tyrosine kinase activity associated with vascular endothelial
growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR),
which both inhibit angiogenesis, and colony stimulating factor-1 receptor
(CSF-1R), which regulates tumor-associated macrophages, promoting the body's
immune response against tumor cells. Surufatinib is marketed in China by
HUTCHMED under the brand name SULANDA(®). HUTCHMED currently retains all
rights to surufatinib worldwide.

 

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the
programmed death-1 (PD-1) receptor. Camrelizumab has been approved in China
for multiple indications in areas such as lung cancer, liver cancer,
esophageal cancer, nasopharyngeal cancer and cervical cancer. Camrelizumab is
marketed in China by Hengrui Pharma under the brand name AiRuiKa(®).

 

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
therapeutic potential of surufatinib for the treatment of PDAC and the further
development of surufatinib 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 a new drug
application submission of surufatinib for the treatment of PDAC or other
indications in China or other jurisdictions, its potential to gain approvals
from regulatory authorities on an expedited basis or at all, the efficacy and
safety profile of surufatinib, HUTCHMED's ability to fund, implement and
complete its further clinical development and commercialization plans for
surufatinib and the timing of these events. In addition, as certain studies
rely on the use of other drug products such as camrelizumab, nab-paclitaxel
and gemcitabine as combination therapeutics with surufatinib, such risks and
uncertainties include assumptions regarding the safety, efficacy, supply and
continued regulatory approval of these therapeutics. 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    The 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 December 3, 2025

 2    Sarantis P et al. Pancreatic ductal adenocarcinoma: Treatment hurdles,
tumor microenvironment and immunotherapy. World J Gastrointest Oncol.
2020;12(2):173-181. DOI:10.4251/wjgo.v12.i2.173
(https://doi.org/10.4251%2Fwjgo.v12.i2.173)

 3    Qin S et al. 375P - Surufatinib (S) in combination with camrelizumab
(C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in
metastatic pancreatic cancer: Results from phase II part of a randomized,
open-label, active-controlled, phase II/III study. Annals of Oncology (2025)
36 (suppl_4): S1859-S1939. 10.1016/annonc/annonc1989

 

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