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

This designation follows the ODD granted by the US Food and Drug Administration (FDA) in March 2025, further highlighting HLX22’s potential as a treatment for HER2-positive gastric cancer, states the company.

Henlius is conducting a global Phase 3 clinical trial to evaluate HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer.

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

“The orphan designation to HLX22 in Europe represents another important regulatory milestone for this program. Following the earlier FDA designation, this reinforces the potential clinical and commercial value of the antibody. While Alligator is not directly involved in the development, we look forward to following its progress as it may contribute future revenue to Alligator,” says Søren Bregenholt, CEO of Alligator Bioscience.

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