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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous CAR-T cell targeting HER2 and IL13Ralpha2 that simultaneously secrete CD3 EGFR/EGFRvIII bispecific T cell engagers
Date Designated: 01/18/2024
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Simnova Biotechnology Co., Ltd.
Building 16, Lane 118, Furonghua Road
Pudong New Area
Shanghai, Shanghai 201200
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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