Hutchison Chi-Med upbeat on progress with surufatinib
By Josh White
Date: Monday 20 Jan 2020
(Sharecast News) - Hutchison China MediTech, trading as Chi-Med, announced on Friday that the independent data monitoring committee of the phase 3 pivotal study of surufatinib in advanced neuroendocrine tumours - pancreatic (SANET-p) has completed a pre-planned interim analysis.
The AIM-traded firm said the committee recommended that the study stopped early, as the pre-defined primary endpoint of progression free survival had already been met.
Following the early success of this study, Chi-Med said it now planned to arrange a pre-new drug application meeting with the China National Medical Products Administration (NMPA) to discuss the preparation of the application for surufatinib for the indication.
It said it intended to submit the results of the SANET-p study for presentation at an upcoming scientific conference.
"This positive data is a further important milestone for Chi-Med. Following surufatinib's NDA submission for the treatment of non-pancreatic neuroendocrine tumours, these positive results for pancreatic neuroendocrine tumours reinforce that surufatinib has the unique opportunity to address all advanced neuroendocrine tumours," said Chi-Med chief executive officer Christian Hogg.
"We believe that no targeted therapies are approved in China or globally for such a broad spectrum of neuroendocrine tumour disease."
In November, the US Food and Drug Administration (FDA) granted orphan drug designation to surufatinib for the treatment of pancreatic neuroendocrine tumours.
The China new drug application for surufatinib for the treatment of advanced non-pancreatic neuroendocrine tumours was accepted for review by the NMPA, and was subsequently granted priority review status in December.
Currently, Chi-Med said it was building an oncology-focused sales and marketing team to launch surufatinib, if approved, in China.
At 1548 GMT, shares in Hutchison China MediTech were down 0.58% at 447.4p.
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