On February 10, 2026, Shanghai Heyu Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as "Heyu Biopharmaceutical", HKEX code: 02256) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Heyu Biopharmaceutical's independently developed highly selective small molecule FGFR4 inhibitor, ipraginib (Irpagratinib/ABSK-011) , for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received immune checkpoint inhibitor (ICI) and multi-target kinase inhibitor (mTKI) therapy and have FGF19 overexpression.

Currently, there is a lack of effective follow-up treatment options for patients with advanced or unresectable HCC after ICI and mTKI therapy. Studies show that approximately 30% of HCC patients overexpress FGF19, and these patients have a relatively poor prognosis after first-line targeted immunotherapy. Therefore, precise targeted therapy against the FGF19/FGFR4 signaling pathway holds promise for providing new and effective options for these patients.

Ipatoloteinib is a highly selective FGFR4 inhibitor independently developed by Heyu Pharmaceuticals for the treatment of patients with advanced HCC overexpressing FGF19. The FDA's grant of Free Treatment Date (FTD) is primarily based on positive results from the Phase I clinical trial presented by the company at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. Data showed that in patients with advanced HCC who had failed prior ICI and mTKI therapy and exhibited FGF19 overexpression, ipelaginib monotherapy demonstrated significant efficacy, good safety, and tolerability, with an objective response rate (ORR) of 46.7% and a median progression-free survival (mPFS) of 5.5 months.

In May 2025, epagogltinib received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and initiated a pivotal registration clinical trial covering more than 50 research centers nationwide. Academician Chen Xiaoping of the Chinese Academy of Sciences previously highly praised the project, believing that epagogltinib has the potential to become the world's first truly precise targeted therapy for liver cancer, bringing long-term survival benefits to patients.

Furthermore, at the 2025 European Society for Medical Oncology Gastrointestinal Cancer Congress (ESMO-GI), Heyu Pharmaceuticals presented the latest research results of epagoglinib combined with atezolizumab for the treatment of HCC. In treatment-naïve and previously treated ICI-treated patients with FGF19-overexpressing HCC, the combination therapy achieved an ORR of over 50%, a median progression-free survival (mPFS) of over 7 months, and no new safety signals were observed, demonstrating its potential to challenge first-line treatment options for hepatocellular carcinoma.

This FDA Fast Track designation will help accelerate the global clinical development and registration of epagoglottinib. Heyu Pharmaceuticals will continue to advance the international clinical deployment of this project, committed to providing more precise and effective innovative treatment options for HCC patients.

About ipragutinib (ABSK-011)

Ipatagotinib (ABSK-011) is a highly selective small-molecule FGFR4 inhibitor developed for the treatment of advanced hepatocellular carcinoma (aHCC) with FGF19 overexpression. Studies have shown that approximately 30% of HCC patients worldwide have FGF19 overexpression. Developing targeted therapies against this signaling pathway represents a novel and innovative approach to treating HCC.

Currently, no FGFR4 inhibitors have been approved for marketing globally. According to Frost & Sullivan's analysis, epagogtinib, with its leading position in the competitive landscape, is expected to become the first breakthrough drug for treating patients with FGF19-overexpressing HCC.

In addition to monotherapy, Heyu Pharmaceuticals is also exploring a Phase II trial of epagoglottinib in combination with the anti-PD-L1 antibody atezolizumab (manufactured by F. Hoffmann-La Roche Ltd. and Roche (China) Investment Co., Ltd.). At the 2025 ESMO-GI Congress, Heyu Pharmaceuticals presented the latest clinical trial data on combination therapy for aHCC patients. In the cohort of epagoglottinib in combination with atezolizumab, the objective response rate (ORR) exceeded 50% in both treatment-naïve and previously ICI-treated FGF19-overexpressing HCC patients, and the median progression-free survival (mPFS) exceeded 7 months.

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