20th Sep 2021 09:09
(Alliance News) -Â Hutchmed (China) Ltd on Monday said it has initiated a bridging study in Japan to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors.
Following talks with the Japanese Pharmaceuticals & Medical Devices Agency, it was agreed that surufatinib's new drug application for the treatment of advanced NETs include results from a study conducted in Japan.
The Japan study will be a two-stage, open-label study of surufatinib into which around 34 patients are expected to be recruited. The safety and tolerability of surufatinib will be evaluated in the first phase, and efficacy will be the focus of part two of the study.
The first patient was dosed last Wednesday.
Surufatinib, to which Hong Kong-based pharmaceutical company Hutchmed currently holds all global rights, is a novel, oral angio-immuno kinase inhibitor.
Shares in Hutchmed were up 2.7% at 571.00 pence in London early Monday.
By Lucy Heming;Â [email protected]
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