[{"orgOrder":0,"company":"Hutchison China MediTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chi-Med Announces that Surufatinib Phase III SANET-p Study Has Already Achieved its Primary Endpoint in Advanced Pancreatic Neuroendocrine Tumors in China and Will Stop Early","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"HONG KONG","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Hutchison China MediTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chi-Med's Surufatinib Bags US Fast Track Designations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"HONG KONG","productType":"Small molecule","productStatus":"New Molecular 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Tislelizumab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Undisclosed","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Innovent Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innovent Announces First Patient Dosed in a Phase 1b Clinical Trial of Sintilimab plus Surufatinib in Advanced Malignancies in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Hutchison China MediTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chi-Med Plans to Submit Marketing 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molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Hutchmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUTCHMED Initiates SURTORI-01, a Phase III Trial of SULANDA\u00ae in Combination with TUOYI\u00ae in the Treatment of Advanced Neuroendocrine Carcinoma in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"HONG KONG","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Hutchmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUTCHMED Highlights Surufatinib and Toripalimab Combination Clinical Data being Presented at the ESMO Immuno-Oncology 2021 Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"HONG KONG","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Hutchmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUTCHMED Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"HONG KONG","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Surufatinib
Safety and efficacy of HMPL-012 (surufatinib), an oral inhibitor of angiogenesis and immune modulation, was demonstrated in SANET-p and SANET-ep studies, in patients with advanced pNETs and epNETs conducted in China.
SURTORI-01, a Phase III study to evaluate the efficacy and safety of surufatinib (SULANDA), a novel, oral angio-immuno kinase inhibitor in combination with toripalimab compared with FOLFIRI to treat patients with advanced neuroendocrine carcinoma.
Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.
This trial is to explore potential synergistic activity of the novel, oral angio-immuno kinase inhibitor surufatinib with the anti-PD-1 antibody tislelizumab in enhancing overall antitumor activity from inhibition of angiogenesis along with stimulation of an immune response.
The NMPA approval of Sulanda® was based on results from the SANET-ep study. The Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio.
The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio.
Phase III SANET-p demonstrated surufatinib reduces the risk of disease progression or death by 51% in patients with pancreatic neuroendocrine tumors (“NET”).
The NDA is supported by data from the successful SANET-p study, a Phase III pivotal study of surufatinib in advanced neuroendocrine tumors – pancreatic patients in China for whom there is no effective therapy.
New and updated analyses on the studies of surufatinib and fruquintinib will be presented at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020.
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