Abbisko Cayman Limited (the “Company”), together with subsidiary Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics”), reported the successful first U.S. patient dosing in the expansion segment of a global Phase I study (ABSK-011-101) for irpagratinib (ABSK-011), a highly selective small-molecule FGFR4 inhibitor. Irpagratinib previously received Fast Track Designation from the U.S. Food and Drug Administration, indicating potential to accelerate its clinical progress for advanced hepatocellular carcinoma (HCC) exhibiting FGF19 overexpression.

Results from the completed China dose-escalation phase showed durable antitumor activity and a favorable safety profile in this patient population. In the subgroup previously treated with immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs), the inhibitor achieved an objective response rate of 46.7% and a median progression-free survival of 5.5 months, as presented at the 2024 European Society for Medical Oncology Congress. A combination therapy study with atezolizumab revealed an objective response rate exceeding 50% and a median progression-free survival of more than seven months, reported at the 2025 ESMO Gastrointestinal Cancers Congress. The Company advised that the ultimate market success of ABSK-011 is not guaranteed and encouraged shareholders and potential investors to exercise caution when dealing in its shares.