29th Dec 2020 12:31
(Alliance News) - Hutchison China MediTech Ltd on Tuesday said it has initiated a new drug application filing to the US Food & Drug Administration for surufatinib, a treatment for pancreatic and non-pancreatic neuroendocrine tumours.
The China-based biopharmaceutical company received fast track designation from the FDA in April, which allows it to submit sections of the new drug application on a rolling basis. It said it plans to complete the rolling submission, which is its first in the US, during the first half of 2021.
Hutchison China said the NDA filing was due to positive results from its phase III Sanet-ep trial, which demonstrated that surufatinib reduced risk of progression or death in non-pancreatic NET patients by 67%, and reduced risk of progression or death in pancreatic NET patients by 51%, with an acceptable risk and benefit ratio for both.
Chief Medical Officer & Managing Director Marek Kania said: "There is a great need for additional therapies to treat neuroendocrine tumours, and surufatinib has demonstrated significant clinical benefit in patients with advanced tumours. The NDA filing to the US FDA represents a significant step toward our goal of commercialising surufatinib and other novel therapies globally."
Hutchison China said in September that its new drug application for surufatinib as a treatment for advanced pancreatic NET was accepted for review by China National Medical Products Administration.
Shares in Hutchison China were up 5.4% at 432.00 pence in London on Tuesday.
By Zoe Wickens; [email protected]
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