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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Humanized Recombinant IgG4 Anti-PD-1 Monoclonal Antibody
Date Designated: 07/14/2020
Orphan Designation: Treatment of hepatocellular carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CStone Pharmaceuticals (Suzhou) Co., Ltd.
1000 Zhangheng Road
Building 25
Shanghai 201203
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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