Treatment or new progression of advanced neuroendocrine tumors! Hutchison Whampoa has submitted a marketing authorization application forUrufatinib to the EMA.

Hutchison Whampoa China Pharmaceutical Technology Co., Ltd. (Chi-Med) announced today that it has obtained scientific advice from the European Medicines Agency (EMA) Human Medicines Board (CHMP) for the treatment of advanced neuroendocrine tumors (NET).
completed SANET-ep (Non-Pancreatic NET) and SANET-p (Pancreatic NET) studies, as well as data support marketing authorization applications (MAA) for non-pancreatic and pancreatic NET patients in the United States.
Hutchison Whampoa plans to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2021.
Urufatinib is a new type of oral vascular immunokinase inhibitor that selectively inhibits tyrosine kinase activity associated with vascular endotoriasis factor receptors (VEGFR) and fibroblast growth factor receptors (FGFR), and Surufatinib regulates tumor-related macrophages to promote the body's immune response to tumor cells.
U.S., Surufatinib was awarded the fast-track title of Treatment NET in April 2020 and the Orphan Drug for Pancreatic NET in November 2019.
, China's National Drug Administration (NMPA) began reviewing Surufatinib's NDA for the treatment of patients with advanced non-pancreatic NET in November 2019.
The progress was supported by DATA from the SANET-ep study, a Phase III study of Surufatinib's treatment of non-pancreatic NET patients in China, and a mid-term analysis of 198 patients in June 2019 showed that Surufatinib significantly extended patients' progression-free survival (PFS).
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