Hutchison China MediTech Limited said on Friday that it got approval from the China’s authority, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), a Priority Review status to the New Drug Application (NDA) for surufatinib, for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (NET).
Surufatinib is Hutchison’s second drug to be granted priority review by China’s national administration, said Christian Hogg, Chief Executive Officer of Chi-Med. He said that the company is collaborating with the national body as they review its new drug application for the treatment of non-pancreatic NET. “Surufatinib being granted priority review is a positive step forward in potentially bringing this innovative drug to patients, who currently have very limited treatment options,” he said.
In November 2019, the NDA for surufatinib for the treatment of non-pancreatic NET was accepted for review by the NMPA, and the U.S. Food and Drug Administration granted Orphan Drug designation to surufatinib for the treatment of pancreatic NET, the company reminded.