ABBISKO-B (02256): The FGFR2/3 inhibitor ABSK061 has obtained FDA approval for the treatment of pediatric achondroplasia.

date
17:33 30/03/2026
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GMT Eight
Henghe-B (02256) announced that its subsidiary, Shanghai Henghe Biopharmaceutical Technology Co., Ltd. ("Henghe Biopharma"), has received approval from the U.S. Food and Drug Administration (FDA) for the new drug clinical trial application (IND) of its highly selective small molecule FGFR2/3 inhibitor ABSK061 for the treatment of children with achondroplasia ("ACH"). Combined with the rare pediatric disease designation (RPDD) and orphan drug designation (ODD) previously granted by the FDA, this development will help accelerate Henghe Biopharma's overseas clinical development process for ABSK061.
ABBISKO-B (02256) announced that its subsidiary Shanghai Heyu Biomedical Technology Co., Ltd. ("Heyu Medicine") has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of its highly selective small molecule FGFR2/3 inhibitor ABSK061 for the treatment of children with Achondroplasia ("ACH"). Combined with the Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) previously granted by the FDA, this development will help accelerate the overseas clinical development process of ABSK061 for Heyu Medicine.