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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  humanized bispecific IgG1 antibody that can simultaneously bind to both programmed death-ligand 1 and cytotoxic T-lymphocyte-associated protein 4
Date Designated:  09/02/2020
Orphan Designation:  Treatment of Thymic Epithelial Tumors
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Bldg. C23, 218 Xinghu Street,
SIP
SuZhou, Jiangsu
China

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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