Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal ...

SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22 ...

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action ...

LUND, SE / ACCESS Newswire / March 20, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX) today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) t ...

SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the ...

HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator. The FDA's ODD provides incentives such ...