Latest news with #Abbisko
Yahoo
16-06-2025
- Health
- Yahoo
Abbisko Therapeutics Completes First Patient Dosing in Registrational Study of Irpagratinib for HCC
SHANGHAI, June 15, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) today announced that it has completed first patient dosing in a registrational study of irpagratinib, a self-developed and highly-selective small molecule FGFR4 inhibitor, for the treatment of Hepatocellular Carcinoma (HCC). In May, irpagratinib received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). It is the first therapeutic agent to utilize molecularly defined biomarkers for precision-targeted treatment of HCC. The vast majority of patients with advanced HCC treated with current standard-of-care therapies—including immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs)— experience disease progression within one year. Additionally, approximately 30% of HCC patients exhibit FGF19 overexpression, a biomarker associated with more aggressive tumor biology and poorer prognosis. The registrational study of irpagratinib (ABSK-011-205) is a multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of irpagratinib in combination with Best Supportive Care (BSC) versus placebo in combination with BSC, in patients with advanced or unresectable HCC who exhibit FGF19 overexpression and have previously been treated with ICIs and mTKIs. Eligible patients will be randomized in a 2:1 ratio to receive irpagratinib or placebo. 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: 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 for more information. View original content: SOURCE Abbisko
Yahoo
26-05-2025
- Business
- Yahoo
China's CDE grants breakthrough status approval to Abbisko's HCC therapy
The China National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation approval to Abbisko Therapeutics' fibroblast growth factor receptor 4 (FGFR4) small molecule inhibitor, irpagratinib, for treating hepatocellular carcinoma (HCC). The therapy claims to be the first therapeutic agent to utilise molecularly defined biomarkers for precision-targeted HCC treatment. The CDE's decision is supported by encouraging data from the Phase I trial, indicating the potential of the therapy to fill a treatment void for individuals with advanced or unresectable HCC, who have limited options after undergoing immune checkpoint inhibitor (ICI)- and multitargeted tyrosine kinase inhibitor (mTKI)-based treatments. Specifically, those with overexpression of FGF19, linked to a worse prognosis, stand to benefit from this new treatment approach. The designation is expected to accelerate the regulatory process for the therapy, offering hope to patients with HCC. Abbisko has already initiated a pivotal registrational clinical trial of the therapy at Tongji Hospital and Nanjing Tianyinshan Hospital, targeting HCC subjects with overexpression of FGF19. Irpagratinib's mechanism of action involves the targeting of the FGF19 signalling pathway, which is overexpressed in nearly 30% of HCC subjects globally. Moreover, the company is conducting a Phase II trial of irpagratinib in conjunction with an anti-programmed death ligand 1 (PD-L1) antibody, atezolizumab from F. Hoffmann-La Roche and Roche (China). According to the clinical data presented by the company previously, this combination of 220mg of irpagratinib twice daily and atezolizumab showed a 50% objective response rate (ORR) in FGF19-positive individuals with HCC. Abbisko was founded in April 2016 and is based in China. In 2023, Abbisko reported updated outcomes from a Phase Ib trial of Pimicotinib (ABSK021) for treating advanced tenosynovial giant cell tumour (TGCT). "China's CDE grants breakthrough status approval to Abbisko's HCC therapy" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
26-05-2025
- Health
- Yahoo
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: 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 for more information. References: 1. NMPA突破性治疗药物审评工作程序. View original content: SOURCE Abbisko Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-05-2025
- Business
- Yahoo
Abbisko Therapeutics to Present Updated Results from the Phase 2 Study of Irpagratinib in Combination with Atezolizumab for the Treatment of Advanced Hepatocellular Carcinoma at the 2025 ESMO GI Congress
SHANGHAI, May 13, 2025 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ( today announced that updated results from the phase 2 study of irpagratinib (ABSK011) in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the 2025 ESMO GI Congress, taking place in Barcelona, Spain from July 2 to July 5. The oral presentation will highlight the regimen's favorable safety and promising anti-tumor activity in both treatment-naive and previously treated FGF19+ HCC patients. The evident objective response rate (ORR) and progression free survival (PFS) benefit underscores the potential of irpagratinib-based combinations in the treatment of HCC. Event Details: Session: Mini Oral session - Innovation in GI cancersPresentation Format: Oral Presentation Title: Irpagratinib (ABSK-011) plus Atezolizumab in First-line (1L) and Immune Checkpoint Inhibitors (ICIs) Treated Advanced Hepatocellular Carcinoma (HCC) with FGF19 Overexpression (+): Updated Results of the Phase 2 ABSK-011-201 Study Presentation number：149MO Presenter: Qi ChengDate and Time: Beijing Time 2Jul2025 23:15-23:20 Local time 2Jul2025 17:15-17:20 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 aHCC 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. View original content: SOURCE Abbisko Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
