On September 26, 2023, Abbisko Therapeutics Co. Ltd. announced that Irpagratinib (ABSK011), a highly selective small molecule inhibitor of FGFR4, in combination with Lenvatinib in patients with advanced or unresectable HCC has obtained an IND approval for Phase II trial from the NMPA. The approved study aims to evaluate the safety, tolerability and efficacy of Irpagratinib in combination with Lenvatinib in advanced or unresectable HCC patients.

This is the second Irpagratinib combination study in HCC after the Phase II trial of Irpagratinib in combination with the anti-PD-L1 antibody Atezolizumab. In December 2022, Abbisko Therapeutics announced preliminary results of Phase I trial of Irpagratinib as second-line treatment for HCC patients with FGF19 overexpression in China, which showed excellent safety and efficacy. Abbisko Therapeutics will present updates on Irpagratinib's Phase I clinical trial at the European Society for Medical Oncology (ESMO) Annual Meeting in October 2023.