Abbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC
SHANGHAI, May 26, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Hepatocellular Carcinoma (HCC). Irpagratinib is the first therapeutic agent to leverage molecularly defined biomarkers for precision-targeted treatment in patients with HCC.
During clinical trials, innovative drugs or modified new drugs intended to prevent or treat life-threatening diseases or conditions that severely impact quality of life—where no effective prevention or treatment exists, or where substantial evidence shows significant clinical advantages over existing therapies—may be eligible to apply for the CDE's Breakthrough Therapy Designation program[1]. The approval of irpagratinib for Breakthrough Therapy Designation is based on its promising Phase I clinical trial data.
Patients with advanced or unresectable HCC currently lack effective treatment options following treatment with ICI- and mTKI-based therapies. Those with FGF19 overexpression often face significantly worse prognosis, and thus new treatment options are urgently needed. The Breakthrough Therapy Designation granted to irpagratinib will expedite its subsequent application and approval process with the CDE, bringing renewed hope and transformative possibilities to patients.
Recently, Abbisko launched a pivotal registrational clinical study of irpagratinib for the treatment of HCC patients with FGF19 overexpression at Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, and Nanjing Tianyinshan Hospital.
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 previous 2024 ESMO GI Congress, Abbisko presented clinical data demonstrating 220mg irpagratinib BID in combination with atezolizumab achieved a 50% objective response rate (ORR) in FGF19+ HCC patients who had previously received immune checkpoint inhibition therapy.
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.
References:
1. NMPA突破性治疗药物审评工作程序. https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html
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