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Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Fruquintinib was approved by the China National Medical Products Administration (“NMPA”) in September 2018 under the brand name Elunate®. The NMPA approval was based on the results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic colorectal cancer in China demonstrating improvement in overall survival (clinicaltrials.gov identifier: NCT02314819).
A Global Phase III trial of fruquintinib in metastatic colorectal cancer is ongoing; first patient was dosed in September 2020.
HUTCHMED retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.
* fruquintinib is not approved for use outside of China
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) 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. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
Surufatinib was approved by the China National Medical Products Administration (“NMPA”) in December 2020 under the brand name Sulanda®. The NMPA approval of Sulanda® was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced non-pancreatic NETs conducted in China.
Filing of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) was initiated in December 2020 – the first portion of a rolling submission for surufatinib for the treatment of pancreatic and non-pancreatic NETs.
HUTCHMED currently retains all rights to surufatinib worldwide.
* surufatinib is not approved for use outside of China