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HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced

HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced
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HUTCHMED Initiates a Japan Bridging Study to Support

HUTCHMED Initiates a Japan Bridging Study to Support
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Investegate |Hutchmed China Ltd Announcements | Hutchmed China Ltd: Total Voting Rights

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HUTCHMED s Marketing Authorization Application for Surufatinib Submitted and Validated by the European Medicines Agency

Share: – EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumors – – Expands potential global reach of surufatinib, in addition to China where it is already launched, and in the U.S. where it is under review for marketing approval – HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., July 15, 2021 (GLOBE NEWSWIRE) HUTCHMED (China) Limited ( HUTCHMED ) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the European Medicines Agency ( EMA ) has validated and accepted its marketing authorization application ( MAA ) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors ( NETs ). The EMA s validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process.

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