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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: toripalimab-tpzi
Trade Name: Loqtorzi
Date Designated: 05/18/2020
Orphan Designation: Treatment of nasopharyngeal carcinoma
Orphan Designation Status: Designated/Approved
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, California 94065
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: toripalimab-tpzi
Trade Name: Loqtorzi
Marketing Approval Date: 10/27/2023
Approved Labeled Indication: In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC); and as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy
Exclusivity End Date: 10/27/2030 
Exclusivity Protected Indication* :  first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC); and for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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