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China NMPA grants breakthrough therapy designation to Abbisko Therapeutics’ irpagratinib to treat hepatocellular carcinoma

27 May 2025
Admin
News Article

China NMPA grants breakthrough therapy designation to Abbisko Therapeutics’ irpagratinib to treat hepatocellular carcinoma

Abbisko Therapeutics, a leading oncology-focused biopharmaceutical company based in Shanghai, has announced that its self-developed, highly selective FGFR4 inhibitor, irpagratinib (ABSK011), has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).

This marks a milestone achievement as irpagratinib becomes the first targeted therapy for hepatocellular carcinoma (HCC) that uses molecularly defined biomarkers for precision treatment.

What is Irpagratinib?

Irpagratinib (ABSK011) is a small molecule inhibitor specifically designed to block FGFR4, a receptor linked to the FGF19 signaling pathway.
Approximately 30% of HCC patients worldwide exhibit FGF19 overexpression, a subgroup with particularly poor prognosis.
Irpagratinib is tailored to provide a precision-targeted approach for these high-risk patients.

Significance of the Breakthrough Therapy Designation (BTD)

The BTD was granted based on promising Phase I clinical trial data.
The designation expedites the drug’s development, review, and potential approval in China.
It is typically reserved for treatments that address serious or life-threatening conditions with no existing effective therapies or where significant improvement over standard of care is evident.

Addressing Unmet Needs in Hepatocellular Carcinoma (HCC)

HCC is among the most common and deadly forms of liver cancer.
Many patients fail to respond to current treatments such as immune checkpoint inhibitors (ICIs) or multi-tyrosine kinase inhibitors (mTKIs).
For those with FGF19 overexpression, the prognosis is even worse—underscoring the urgency of new treatment solutions.

Clinical Development Highlights

Abbisko has launched a pivotal clinical study of irpagratinib in HCC patients with FGF19 overexpression.
Leading sites include:
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
- Nanjing Tianyinshan Hospital

Promising Combination Therapy Results

Irpagratinib is also being studied in combination with atezolizumab, a PD-L1 checkpoint inhibitor from Roche.
At the 2024 ESMO GI Congress, data from a Phase II study showed:
- 220mg BID irpagratinib + atezolizumab
- Achieved a 50% objective response rate (ORR) in FGF19+ HCC patients who had previously failed immunotherapy.

Global Industry Impact & Market Potential

Currently, no FGFR4 inhibitors have been approved anywhere in the world.
According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough therapy approved specifically for FGF19+ HCC patients.

Key Takeaways

Breakthrough Therapy Designation for irpagratinib by China’s NMPA
First biomarker-driven targeted therapy in HCC to reach this stage
Strong Phase I data and pivotal trials underway
Potential global first-in-class approval of an FGFR4 inhibitor
Combination with atezolizumab shows 50% ORR in previously treated patients