HeYu's independently developed new drug has received FDA Fast Track designation
Abbisko-B (02256.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Abbisko's independently developed highly selective small molecule FGFR4 inhibitor Irpagratinib (ABSK-011) Fast Track Designation (FTD) for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received immune checkpoint inhibitors (ICIs) and multi-target kinase inhibitors (mTKIs) and have FGF19 overexpression.
This will help accelerate the clinical development and regulatory review process of Irpagratinib globally. Abbisko will continue to advance the international clinical layout of this project, committed to providing more precise and effective innovative treatment solutions for HCC patients worldwide
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