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

Rhea-AI Summary

HUTCHMED (Nasdaq/AIM: HCM) has initiated the Phase III portion of its Phase II/III trial evaluating surufatinib + camrelizumab + nab-paclitaxel + gemcitabine (S+C+AG) as first-line treatment for metastatic pancreatic ductal adenocarcinoma in China, with the first patient dosed on Dec 30, 2025.

The Phase III plans ~400 additional patients (62 in Phase II). Primary endpoint is overall survival (OS). Phase II results showed median PFS 7.20 vs 5.52 months (HR 0.499, p=0.0407), ORR 67.7% vs 41.9% (p=0.0430) and DCR 93.5% vs 71.0% (p=0.0149). OS was immature (not reached vs 8.48 months, unstratified HR 0.555). Safety: grade ≥3 TEAEs 80.6% vs 61.3%.

Positive

• Median PFS improved to 7.20 months (HR 0.499, p=0.0407)
• ORR 67.7% for S+C+AG versus 41.9% for AG (p=0.0430)
• DCR 93.5% for S+C+AG versus 71.0% for AG (p=0.0149)

Negative

• Grade ≥3 TEAEs occurred in 80.6% of S+C+AG patients versus 61.3% for AG
• Overall survival data immature (not reached vs 8.48 months; unstratified HR 0.555)

News Market Reaction – HCM

-2.05%

-2.05% Session close to close

In the Jan 5 session, HCM declined 2.05%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances HUTCHMED’s pancreatic cancer program into a Phase III stage after Phase I...

Analysis

This announcement advances HUTCHMED’s pancreatic cancer program into a Phase III stage after Phase II data showed improved progression-free survival, response rates, and disease control versus standard chemotherapy. The study’s primary endpoint is overall survival, with quality-of-life and safety as key secondary measures. Investors may watch future readouts for mature survival data, the durability of responses, and how manageable the higher rate of grade ≥3 adverse events remains over longer follow-up.

Key Figures

Global pancreatic cases: 511,000 people Global pancreatic deaths: 467,000 deaths Phase II enrollment: 62 patients +5 more

8 metrics

Global pancreatic cases 511,000 people Estimated diagnosed with pancreatic cancer globally in 2022

Global pancreatic deaths 467,000 deaths Estimated deaths from pancreatic cancer globally in 2022

Phase II enrollment 62 patients Patients enrolled in Phase II part of S+C+AG vs AG trial

Planned Phase III enrollment ≈400 patients Additional patients planned for Phase III part

Median PFS S+C+AG 7.20 months Median progression-free survival vs 5.52 months for AG arm

PFS hazard ratio HR 0.499 Stratified hazard ratio for PFS (p=0.0407)

ORR S+C+AG vs AG 67.7% vs 41.9% Objective response rate with combination vs control (p=0.0430)

Grade ≥3 TEAEs 80.6% vs 61.3% Treatment-emergent adverse events in S+C+AG vs AG arms

Historical Context

5 past events · Latest: Dec 30 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Dec 30	Regulatory filing	Positive	-1.5%	China NDA acceptance and priority review for savolitinib in MET-amplified gastric cancer.
Dec 29	Regulatory filing	Positive	-2.7%	China NDA acceptance with priority review for fanregratinib in second-line ICC.
Dec 16	Clinical development	Positive	+0.5%	Initiation of global Phase I/IIa trial of ATTC candidate HMPL-A251 in solid tumors.
Dec 07	Reimbursement update	Positive	-1.3%	NRDL renewal and first commercial insurance drug list inclusion for key oncology drugs.
Nov 26	Data presentations	Positive	+0.7%	Announcement of multiple ESMO Asia and ASH presentations across the oncology portfolio.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news with generally positive oncology/regulatory updates has often seen muted or negative next-day moves, indicating occasional divergence between news tone and price.

Recent Company History

Over the last few months, HUTCHMED reported multiple late-stage and registration-focused oncology milestones, including Chinese NDA acceptances for savolitinib and fanregratinib and expanded reimbursement coverage effective Jan 1, 2026. It also advanced global and regional clinical programs, such as the SAFFRON Phase III and ATTC candidate HMPL-A251. Today’s initiation of a Phase III stage in metastatic pancreatic cancer fits this pattern of broad pipeline execution in difficult tumor types.

Key Terms

pancreatic ductal adenocarcinoma, overall survival, progression-free survival, objective response rate, +3 more

7 terms

pancreatic ductal adenocarcinoma medical

"first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma"

A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.

overall survival medical

"The primary endpoint for the Phase III part is overall survival (OS)."

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

progression-free survival medical

"Secondary endpoints include progression-free survival (“PFS”), objective response rate"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

objective response rate medical

"Secondary endpoints include ... objective response rate (“ORR”), duration of response"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

disease control rate medical

"including ORR (67.7% vs 41.9%, p=0.0430) and DCR (93.5% vs 71.0%, p=0.0149)."

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

hazard ratio medical

"median PFS of 7.20 months compared to 5.52 months for the AG arm (stratified hazard ratio [HR] 0.499"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

treatment-emergent adverse events medical

"Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 80.6%"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 05, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (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.

Results from the Phase II part were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress.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 or follow us on LinkedIn.

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
Media Enquiries
FTI Consulting –	+44 20 3727 1030 / 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
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

______________________________

REFERENCES

1 The Global Cancer Observatory, China fact sheet. 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

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

FAQ

What did HUTCHMED (HCM) announce on January 5, 2026 regarding its PDAC trial?

HUTCHMED announced initiation of the Phase III portion of the Phase II/III trial for S+C+AG in first-line metastatic PDAC, with first patient dosed on Dec 30, 2025.

How many patients will HUTCHMED enroll in the Phase III part of the HCM trial?

The company plans to enroll approximately 400 additional patients in the Phase III portion (62 were in Phase II).

What were the key Phase II efficacy results for HCM's S+C+AG regimen?

Phase II showed median PFS 7.20 vs 5.52 months (HR 0.499, p=0.0407), ORR 67.7% vs 41.9%, and DCR 93.5% vs 71.0% versus AG.

What is the primary endpoint for HUTCHMED's Phase III PDAC study (HCM)?

The primary endpoint for the Phase III part is overall survival (OS).

Where can investors find the HCM clinical trial registration and identifier?

The trial is registered at clinicaltrials.gov under identifier NCT06361888.

How did safety compare between S+C+AG and AG in HUTCHMED's Phase II data?

Grade ≥3 treatment-emergent adverse events were 80.6% with S+C+AG versus 61.3% with AG; the safety profile was described as manageable.