12th Nov 2019 12:19
(Correcting the headline that Hutchison's new drug application has been accepted, but not approved.)
(Alliance News) - Hutchison China Meditech Ltd on Monday said its new drug application for surufatinib has been accepted for review by the China National Medical Products Administration.
Surufatinib was created for the treatment of patients with advanced non-pancreatic neuroendocrine tumors.
The AIM-listed healthcare company said the application was supported by data from the successful SANET-ep study, a phase III study of surufatinib in advanced neuroendocrine tumors pancreatic patients in China for whom there is no effective therapy.
"This new drug application filing puts us on track for the potential approval and launch of surufatinib in China, an important development for neuroendocrine tumors patients with limited treatment options," said Hutchison Chief Executive Christian Hogg.
Hutchison currently retains all worldwide rights to surufatinib, which is under investigation in multiple solid tumours in China, the US and Europe, both as a monotherapy and in combination with immunotherapies.
By Evelina Grecenko; [email protected]
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