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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: penpulimab-kcqx
Trade Name:
Date Designated: 02/23/2021
Orphan Designation: Treatment of nasopharyngeal carcinoma
Orphan Designation Status: Designated/Approved
Akeso Biopharma Co., Ltd.
6 Shennong Road, Torch Development Zone
Zhongshan, Guangdong 528437
China

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

Marketing approved:

1 Generic Name: penpulimab-kcqx
Trade Name:
Marketing Approval Date: 04/23/2025
Approved Labeled Indication: in combination with either cisplatin or carboplatin and gemcitabine, for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC); and as a single agent, for the treatment of adults with metastatic non-keratinizing NPC and disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
Exclusivity End Date: 04/23/2032 
Exclusivity Protected Indication* :  in combination with either cisplatin or carboplatin and gemcitabine, for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC); and as a single agent, for the treatment of adults with metastatic non-keratinizing NPC and disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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