On May 26, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the European Commission has granted orphan drug designation (ODD) to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer (Press release, Alligator Bioscience, MAY 26, 2025, View Source [SID1234653378]). HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

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

Henlius is conducting a global Phase 3 clinical trial (NCT06532006) to evaluate HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer.

Søren Bregenholt, CEO of Alligator Bioscience, commented:
"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."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.