HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it received scientific advice from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) for surufatinib for the treatment of patients with advanced neuroendocrine tumors (“NET”). Based on the CHMP advice, we have concluded 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 marketing authorization application (“MAA”). Given that no filing issues were identified, the MAA submission is planned for 2021, following submission for the U.S. Food and Drug Administration (“FDA”) new drug application (“NDA”).
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