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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cell therapy product derived from an allogeneic hematopoietic stem cell donor and expressed anti-CD19 chimeric antigen receptor, T cell receptor of invariant natural killer T cells, and interleukin-15
Date Designated: 03/02/2026
Orphan Designation: treatment of follicular lymphoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Allovanta Biotechnology Co., Ltd.
Room 308, 3rd Floor, 781 Cailun Road,
(Shanghai) Pilot Free Trade Zone
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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