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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 has been approved by the China National Medical Products Administration (“NMPA”) for the treatment of pancreatic and non-pancreatic neuroendocrine tumors. It is marketed in China under the brand name SULANDA®. The NMPA approval of SULANDA® was based on results from the SANET-ep and SANET-p study, two Phase III trials (clinicaltrials.gov identifier: NCT02588170/NCT02589821) in patients with advanced extra-pancreatic and pancreatic NETs conducted in China.
Filing of a New Drug Application (NDA) for surufatinib with the U.S. Food and Drug Administration (FDA) has been accepted on July 1, 2021. A Marketing Authorization Application for surufatinib has also been submitted and validated by the European Medicines Agency (EMA).
HUTCHMED currently retains all rights to surufatinib worldwide.
* surufatinib is not approved for use outside of China
Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.
Savolitinib was granted conditional approval by the China National Medical Products Administration (“NMPA”) in June 2021, for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is marketed in China under the brand name ORPATHYS®. The NMPA approval of ORPATHYS® was based on results from a Phase II study in China (clinicaltrials.gov identifier: NCT02897479) ; results of this study were published in The Lancet Respiratory Medicine.
In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide.
* savolitinib is not approved for use outside of China