Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 412

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 412
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 respectively. Surufatinib also reduced VEGF- or FGF-stimulated human umbilical vein endothelial cell proliferation with an IC50 < 50 nM. In animal studies, a single oral dose of surufatinib inhibited VEGF-stimulated VEGFR2 phosphorylation in lung tissues of nude mice in an exposure-dependent manner. Elevation of FGF23 levels in plasma 24 hours post dosing suggested suppression of FGFR signaling. Surufatinib demonstrated potent tumor growth inhibition in multiple human xenograft models and decreased cluster of differentiation 31 expression remarkably, suggesting strong inhibition on angiogenesis through VEGFR and FGFR signaling.
In a syngeneic murine colon cancer model, surufatinib demonstrated moderate tumor growth inhibition after single-agent treatment. Flow cytometry and immunohistochemistry analysis revealed an increase of certain T cells and a significant reduction in certain tumor-associated macrophages, including CSF-1R mutation positive tumor-associated macrophages in tumor tissue, indicating surufatinib has a strong effect on CSF-1R. A combination of surufatinib with a PD-L1 antibody resulted in enhanced anti-tumor effect. These results suggested that surufatinib has a strong effect in modulating angiogenesis and cancer immunity.
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Surufatinib Clinical Development

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Treatment                                  Trial Name, Patient Focus          Sites       Phase        Status/Plan                      NCT #      
Surufatinib + Airuika + chemotherapy       1L PDAC                            China       II/III       Fully enrolled Phase II          NCT06361888
Surufatinib                                SANET-ep: Non-pancreatic NET       China       III          Approved; Launched in 2021       NCT02588170
Surufatinib                            ​   SANET-p: Pancreatic NET        ​   China   ​   III      ​   Approved; Launched in 2021   ​   NCT02589821
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Surufatinib Combination – Pancreatic Cancer
Phase II/III study of surufatinib in combination with Airuika and chemotherapy in 1L PDAC (NCT06361888)
We started a China Phase II/III multicenter, randomized, open-label, active-controlled study in adults with metastatic pancreatic cancer who have not been previously treated with