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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: stem cell-derived protein complex derived from the secretome of human mesenchymal stem cells
Date Designated: 09/08/2026
Orphan Designation: treatment of amyotrophic lateral sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.
Room 04, 1st Floor, Building A12, Phase II, Biological Innovation Park,
No. 1 Jiufeng 1st Road, Wuhan East Lake High-Tech Development Zone
Wuhan, Hubei Province 430070
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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