HLX22
Through its subsidiary Atlas Therapeutics AB, Alligator holds a participating interest in the HER2-directed antibody HLX22 (AC101), developed by Shanghai Henlius Biotech, Inc. under license from AbClon, Inc., following a discovery collaboration. Under the agreement, Alligator incurs no development costs but is entitled to 35% of milestone and royalty income that AbClon receives from Henlius. To date, Alligator has received milestone payments totaling USD 3 million.
Project summary
HLX22 is currently being evaluated in several clinical studies across HER2-positive cancers. These include a global Phase 3 trial in gastric and gastroesophageal junction (GEJ) cancer, a Phase 2 trial in gastric cancer expected to complete in 2025, and a recently initiated Phase 2 trial in HER2-positive breast cancer. Together, these studies expand the clinical potential of HLX22 across multiple tumor types.
The most advanced clinical study of HLX22 dosed it’s first patient in the global Phase 3 trial (HLX22-GC-301) in Q3 2025, a trial evaluating HLX22 in combination with trastuzumab and chemotherapy as first-line therapy in HER2-positive metastatic gastric and GEJ cancer. The program has also been strengthened by the Orphan Drug Designations granted by the FDA and the European Commission earlier in 2025, which provide regulatory and commercial advantages .
In December 2025, Henlius received regulatory approval in China to initiate a Phase 2/3 trials of HLX22 in HER2-positive breast cancer, further expanding the clinical and commercial potential of the drug candidate.
If HLX22 is successfully developed and approved, the program could generate substantial milestone payments and recurring royalty revenues. Based on current market assessments, annual royalty income to Alligator has the potential to reach SEK 150–400 million, representing a significant value driver alongside mitazalimab.
Communication policy regarding HLX22 and related programs
Alligator does not lead the development of HLX22 or any related product candidates and therefore does not issue independent development updates.
To ensure that Alligator’s external communication is consistent, accurate, and aligned with information released by Henlius, Alligator’s communication regarding HLX22, and any related programs, is based on the following principles:
Alligator primarily relays, references, and, when relevant, comments on official announcements, press releases, and public disclosures made by Henlius. Alligator does not provide guidance beyond what has been publicly communicated by Henlius, and does not comment on third-party information or speculate on figures, projections, or interpretations reported by third parties (including our collaboration partner Abclon).