HUTCHMED Advances Surufatinib/Camrelizumab Combo to Phase III for Untreated Pancreatic Cancer

HUTCHMED Advances Pancreatic Cancer Program to Phase III with Combination Therapy

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., January 5, 2026 – HUTCHMED announced today the initiation of the Phase III portion of its Phase II/III trial evaluating a combination therapy for metastatic pancreatic ductal adenocarcinoma (PDAC) in China. The first patient in this pivotal Phase III arm was dosed on December 30, 2025. This significant step forward aims to build upon promising Phase II results for the surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine (S+C+AG) regimen as a first-line treatment for this notoriously aggressive cancer.

Pancreatic cancer, particularly PDAC which accounts for over 90% of cases, presents a formidable challenge in oncology. Globally, the disease carried a grim prognosis in 2022, with an estimated 511,000 diagnoses and 467,000 deaths, and a five-year survival rate below 10%. In China alone, the figures were substantial, with approximately 119,000 new cases and 106,000 deaths in the same year. Despite current treatment modalities like chemotherapy, surgery, and radiation, significant improvements in patient outcomes have remained elusive, with fewer than 20% of metastatic PDAC patients surviving beyond one year.

The current Phase II/III study is a multicenter, randomized, open-label, active-controlled trial designed to rigorously assess the efficacy and safety of the S+C+AG combination compared to nab-paclitaxel plus gemcitabine (AG) in patients with metastatic pancreatic cancer who have not received prior systemic anti-tumor therapy. The Phase II segment of the trial successfully enrolled 62 patients, and the upcoming Phase III portion is slated to include approximately 400 additional participants.

The primary endpoint for the Phase III investigation will be overall survival (OS), a critical measure of treatment benefit. Secondary endpoints are designed to provide a comprehensive view of the therapy’s impact, including progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), patient quality of life, and safety. Professor Shukui Qin from Nanjing Tianyinshan Hospital and Professor Jihui Hao from Tianjin Medical University Cancer Institute and Hospital are leading the clinical investigation. Further details regarding the trial can be found on clinicaltrials.gov under the identifier NCT06361888.

Interim results from the Phase II portion, presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress, demonstrated compelling efficacy signals. As of a July 24, 2025 data cut-off, the S+C+AG regimen achieved a median PFS of 7.20 months, a notable improvement over the 5.52 months observed in the AG arm. This translated to a statistically significant 50.1% reduction in the risk of progression or death (stratified hazard ratio [HR] of 0.499, p=0.0407). Beyond PFS, the combination therapy showed marked enhancements in other key efficacy metrics: the ORR was 67.7% for S+C+AG compared to 41.9% for AG (p=0.0430), and the DCR reached 93.5% versus 71.0% for AG (p=0.0149). While overall survival data remained immature at the time of analysis, a favorable trend was indicated, with the S+C+AG arm not reaching median survival versus 8.48 months in the AG arm.

From a safety perspective, the S+C+AG regimen was deemed manageable. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 80.6% of patients receiving S+C+AG, compared to 61.3% in the AG arm. This elevated rate of severe adverse events warrants careful monitoring throughout the Phase III trial, as patients continue treatment and are followed for longer durations.

**About Surufatinib**
Surufatinib is an internally discovered, novel oral kinase inhibitor developed by HUTCHMED. It targets multiple receptor tyrosine kinases, including VEGFRs and FGFRs, which play roles in tumor angiogenesis, and CSF-1R, which influences the tumor microenvironment and immune response. Marketed in China as SULANDA®, surufatinib is developed by HUTCHMED for various cancer indications.

**About Camrelizumab**
Camrelizumab is a humanized monoclonal antibody that targets the programmed death-1 (PD-1) receptor. Developed by Hengrui Pharma and marketed in China as AiRuiKa®, it has received regulatory approvals for multiple indications in China, including in lung, liver, esophageal, nasopharyngeal, and cervical cancers.

**About HUTCHMED**
HUTCHMED is a biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases. With a strong emphasis on bringing innovative drug candidates from discovery to global markets, HUTCHMED has successfully launched three medicines in China, with one also approved internationally.

**Forward-Looking Statements**
This press release contains forward-looking statements regarding HUTCHMED’s expectations for the therapeutic potential and development of surufatinib, including its Phase III trial for PDAC. These statements are subject to risks and uncertainties, including the timing and outcomes of clinical studies, regulatory approvals, and the safety and efficacy profile of surufatinib and other investigational agents. Investors are cautioned not to place undue reliance on these statements.