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China FDA Accepts JHL’s First Clinical Trial Application

JHL1101 is a biosimilar that JHL is pursuing as part of its strategic biologics alliance with Sanofi

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By: Tim Wright

Editor-in-Chief, Contract Pharma

JHL Biotech’s clinical trial application (CTA) for JHL1101 in Phase 1 and Phase 3 clinical trials in non-Hodgkin’s lymphoma patients has been accepted by the China Food and Drug Administration (CFDA). JHL is filing under the new guidelines for biosimilars issued in 2015. JHL1101 is a proposed rituximab biosimilar that JHL is pursuing as part of its strategic biologics alliance with Sanofi, and it is the first product in JHL’s pipeline. Material used to support the CTA was manufact...

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