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    FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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    Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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              RemeGen

              • Development Update

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              FDA Grants Fast Track Designation to RemeGen's Telitacicept as a Treatment for Systemic Lupus Erythematosus

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              Lead Product(s): Telitacicept

              Therapeutic Area: Immunology Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 15, 2020

              Details:

              US FDA granted Fast Track designation for RC18, for the treatment of systemic lupus erythematosus (SLE). RC18 shows statistically significant improvement for patients at multiple doses.

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