(RTTNews) – HUTCHMED (China) Ltd (HCM, HCM.L,0013.HK), a commercial-stage, biopharmaceutical company, announced on Monday that it has commenced the Phase III part of the Phase II/III trial to evaluate the efficacy of the combination of surufatinib combined with camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma or PDAC in China.
Notably, on December 30, 2025, the first patient received the first dose.
Globally, an estimated 511,000 people were diagnosed with pancreatic cancer, and PDAC represents 90% pancreatic cancer cases, leading to approximately 467,000 deaths in 2022, with an average five-year survival rate of less than 10%.
Surufatinib is an oral angi-immuno kinase inhibitor that regulates tumour-associated macrophages, promoting the body’s immune response against tumour cells. In China, Surufatinib is marketed by HUTCHMED under the brand name SULANDA. HUTCHMED currently retains all rights to surufatinib worldwide.
The trial is a multicenter, randomised, 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-tumour therapy.
The primary endpoint for the Phase III part is overall survival. Secondary endpoints include progression-free survival, objective response rate, duration of response, disease control rate, quality of life and safety.
Camrelizumab (SHR-1210) is a humanised monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Camrelizumab has been approved in China for multiple indications 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.
Nab paclitaxel and gemcitabine are two separate chemotherapy drugs that are frequently combined as a first-line treatment for metastatic pancreatic cancer. Nab paclitaxel is sold under the brand name Abraxane by Celgene, part of Bristol Myers Squibb, while gemcitabine was originally introduced as Gemzar by Eli Lilly and Company.
In the Phase II part, the (S+C+AG) regimen demonstrated a median progression-free survival of 7.20 months, compared with 5.52 months in the AG arm, representing a 50.1% reduction in the risk of progression or death.
HCM closed Friday’s trading at $13.65.
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