Search Orphan Drug Designations and Approvals
-
Generic Name: | FC-fusion bispecific antibody targeting extracellular domains II and IV of HER 2 and FC-fusion bispecific IgG1 antibody inhibiting PD-L1 and CTLA-4 |
---|---|
Date Designated: | 12/21/2020 |
Orphan Designation: | Treatment of Gastric Cancer, including Cancer of the Gastroesophageal Junction |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Jiangsu Alphamab Biopharmaceuticals Co., Ltd. Bldg. C23, 218 Xinghu Street SIP SuZhou China The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-