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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lentiviral vector harboring the human NF2 transgene
Date Designated: 03/10/2026
Orphan Designation: treatment of NF2-related schwannomatosis (formerly NF2)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Santo Therapeutics Co., Ltd.
Room 1001, 10th Floor, Building 30, Qianwan Biopark Phase One, Ningwei Street, Xiaoshan District
Hangzhou, Zhejiang
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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