HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator .

Henlius is conducting a Phase 3 clinical trial (HLX22-GC-301) to evaluate HLX22/AC101 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and GEJ cancer. The global study is enrolling patients across the U.S., China, Japan, and Australia.

“The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator,” says Søren Bregenholt, CEO of Alligator.

Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.