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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: serplulimab (Recombinant humanized anti-PD-1 monoclonal antibody injection)
Date Designated: 03/31/2022
Orphan Designation: treatment of small cell lung cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Fosun Pharma USA Inc.
104 Carnegie Center, Suite 204
Princeton, New Jersey 08540
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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