29 June, 2021, Shanghai – Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today announced dosing of the first patient in a phase Ib clinical study in China for ABSK011, a highly selective small molecule inhibitor of FGFR4. The purpose of the open-label, single-arm, multi-center trial is to assess the safety and efficacy of ABSK011 in advanced hepatocellular carcinoma (HCC) patients with FGFR4 pathway alterations.

ABSK011 is discovered and developed by Abbisko with global intellectual property rights. It is an orally administrated, highly potent, and selective small molecule inhibitor of FGFR4 with best-in-class drug-like properties. Phase Ia clinical trial of ABSK011 has been primarily completed to determine its safety, tolerability and pharmacokinetics in patients with advanced solid tumors. RDE has also been determined on this basis.

“FGF19/FGFR4 altered patients account for approximately 30% of total HCC patients worldwide while there were no marketed FGFR4 inhibitors globally as of the date”, said Jing Ji, Chief Medical Officer of Abbisko Therapeutics, “Our prior Phase Ia clinical trial results have demonstrated that ABSK011 has a favorable safety and quality PK/PD profile. The completion of the first patient dosing in a phase Ib clinical study in mainland China is a crucial step for our ABSK011 clinical development, as well as a critical milestone of the company. We believe that ABSK011 is potentially a novel FGFR4 inhibitor in China and globally for the treatment of HCC patients and we will continue to accelerate its global development to address the unmet medical needs.”