Chi-Med Plans to Submit NDA for Surufatinib Following Pre-NDA Meeting with the U.S. FDA

LONDON, June 01, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it has held its pre-New Drug Application (“NDA”) meeting with the U.S. Food and Drug Administration (“FDA”) for surufatinib for the treatment of patients with advanced neuroendocrine tumors (“NET”). Chi-Med has reached an agreement with the FDA that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a U.S. NDA submission.

The FDA granted Fast Track Designation status to surufatinib for the non-pancreatic and pancreatic NET development programs in April 2020. Chi-Med has initiated preparatory work for the U.S. NDA and intends to utilize a rolling submission under Fast Track Designation Status. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. Filing acceptance of the NDA is subject to FDA review of the complete application. The planned start of the NDA submission is late 2020.

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