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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: an autologous cell product derived from the human airway basal cells without any gene modification
Date Designated: 02/04/2025
Orphan Designation: treatment of idiopathic pulmonary fibrosis (IPF)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Regend Therapeutics Co., Ltd.
Bld 38, 100 Banxia Road, Zhangjiang Science City, Pudong New Area
Shanghai, Shanghai 201318
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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