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Country of origin : China

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pp-066

Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
China
Comments
"Indication: Advanced or unresectable hepatocellular carcinoma (HCC) in patients whose tumors exhibit FGF19 overexpression / FGFR4 pathway activation Clinical stage: Registrational (after Breakthrough Therapy Designation in 2025) — monotherapy and combination therapy (with anti-PD-L1) under Phase II / registrational study. Modality: Small-molecule inhibitor (oral) Mechanism / Target: Selective inhibitor of fibroblast growth factor receptor 4 (FGFR4); inhibits FGFR4 autophosphorylation — blocking downstream signaling in tumors dependent on FGF19/FGFR4 axis. Route / form: Oral ( Differentiation: Among the first FGFR4-selective inhibitors targeting FGF19-overexpressing HCC; represents a precision oncology approach for a biomarker-defined subgroup (~30% of HCC patients). If approved, could become the first targeted therapy globally for FGFR4–driven HCC."
Manufacturer #38579

A clinical-stage biopharmaceutical company focused on discovering and developing innovative, targeted therapies in oncology. It applies precision-medicine approaches to address unmet medical needs. The company pursues global development and strategic partnerships to expand patient access.
 

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