Date: 21-Sep-2020

China NMPA Accepts For Review Chi-Meds NDA For Surufatinib To Treat Advanced Pancreatic Neuroendocrine Tumors

Hutchison China MediTech Limited (Chi-Med) announced that its New Drug Application (NDA) for surufatinib for the treatment of patients with advanced pancreatic neuroendocrine tumors (NET) has been accepted for review by the China National Medical Products Administration (NMPA).

The NDA is supported by data from the successful SANET-p study, a Phase III pivotal study of surufatinib in advanced neuroendocrine tumors – pancreatic patients in China for whom there is no effective therapy. The study was terminated early following positive interim analysis completed in January 2020. The positive results of the study demonstrating improvement in progression free survival (PFS) will be presented at the 2020 European Society for Medical Oncology Congress (“ESMO”) (Abstract Number 1156O). This is the second NDA acceptance for surufatinib. The first NDA for non-pancreatic NET was accepted by the NMPA in November 2019 and was granted priority review status in December 2019.

Chi-Med currently retains all worldwide rights to surufatinib. This drug candidate is under investigation in multiple solid tumors in China and the US, both as a monotherapy and in combination with immunotherapies.

In the US, the Food and Drug Administration (FDA) granted Fast Track Designation status to surufatinib for both the non-pancreatic NET and pancreatic NET development programs in April 2020. Chi-Med has initiated preparatory work for the US NDA and intends to utilize a rolling submission, which is expected to start in late 2020. In addition, the Marketing Authorization Application (MAA) submission in Europe is planned for 2021.

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NET is typically classified as pancreatic NET or non-pancreatic NET. Approved targeted therapies include Sutent and Afinitor for pancreatic NET, or well-differentiated, non-functional gastrointestinal or lung NET.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NET in the US in 2018. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with NET in the US in 2018.

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.