10 February 2026, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to irpagratinib (ABSK-011), a highly selective small-molecule FGFR4 inhibitor independently developed by Abbisko Therapeutics, for the treatment of patients with hepatocellular carcinoma (HCC) with FGF19 overexpression who have been previously treated with immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs) therapies.

Currently, patients with advanced or unresectable HCC have limited effective treatment options after failure of ICIs- and mTKIs-based therapies. Studies indicate that approximately 30% of HCC patients have FGF19 overexpression, a subgroup associated with relatively poor prognosis following first-line targeted-immunotherapy combinations. Precision therapies targeting the FGF19/FGFR4 pathway are expected to provide an effective treatment option for these patients.

Irpagratinib is a highly selective FGFR4 inhibitor developed by Abbisko Therapeutics for the treatment of advanced HCC with FGF19 overexpression. The FDA's Fast Track Designation was primarily based on positive results from a Phase I clinical study presented at the 2024 European Society for Medical Oncology (ESMO) Annual Congress. Data demonstrated that irpagratinib monotherapy showed meaningful antitumor activity with a favorable safety and tolerability profile in patients with advanced HCC who had failed prior ICIs and mTKIs therapies and had FGF19 overexpression, achieving an objective response rate (ORR) of 46.7% and a median progression-free survival (mPFS) of 5.5 months.

In May 2025, irpagratinib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), and a pivotal registration clinical study was initiated across more than 50 research centers nationwide. Academician Xiaoping Chen of the Chinese Academy of Sciences has previously spoken highly of the program, noting that irpagratinib has the potential to become the world’s first truly precision-targeted therapy for liver cancer, offering long-term survival benefits to patients.

In addition, Abbisko presented the latest study results of irpagratinib in combination with atezolizumab for the treatment of HCC at the 2025 ESMO Gastrointestinal Cancers Congress (ESMO-GI). In both treatment-naïve patients and those previously treated with ICIs whose tumors exhibited FGF19 overexpression, the combination therapy achieved ORR exceeding 50% and mPFS of more than 7 months, with no new safety signals observed, demonstrating the potential to challenge current first-line treatment paradigms for HCC.

The FDA Fast Track Designation is expected to accelerate the global clinical development and regulatory review of irpagratinib. Abbisko will continue to advance the international clinical development of this program, with the goal of delivering more precise and effective innovative treatment options for patients with HCC worldwide.

About Irpagratinib (ABSK-011)

Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC.

To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of HCC patients with FGF19 overexpression.

In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the the 2025 ESMO GI Congress, Abbisko presented clinical data showing that the combination of irpagratinib and atezolizumab achieved an objective response rate (ORR) exceeding 50% and a median progression-free survival (mPFS) of more than 7 months in FGF19-overexpressing HCC patients previously treated with immune checkpoint inhibitors.

About Abbisko Therapeutics

Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology.

Please visit www.abbisko.com for more information.