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Fruquintinib
ELUNATE® (fruquintinib) is approved in China. Fruquintinib is not approved for use outside of China.
Please see the Pipeline Information for the current status of the product’s development in each country.
Fruquintinib is an oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis.
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 (clinicaltrials.gov identifier: NCT02314819).
HUTCHMED has licensed the rights of fruquintinib to Takeda on a worldwide basis excluding mainland China, Hong Kong and Macau where the rights have been licensed to Eli Lilly and Company.
Surufatinib
SULANDA® (surufatinib) is approved in China. Surufatinib is not approved for use outside of China.
Please see the Pipeline Information for the current status of the product’s development in each country.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that 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.
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. Surufatinib is not approved for use in the U.S.
HUTCHMED currently retains all rights to surufatinib worldwide.
Savolitinib
ORPATHYS® (savolitinib) is approved in China. Savolitinib is not approved for use outside of China.
Please see the Pipeline Information for the current status of the product’s development in each country.
Savolitinib is an oral selective MET TKI that 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 non-small cell lung cancer (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. Savolitinib is not approved for use in the U.S.
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.