和誉-B:FGFR2/3抑制剂ABSK061治疗儿童软骨发育不全的IND获FDA许可

Core Viewpoint - The company, He Yu-B (02256), announced that its subsidiary, Shanghai He Yu Biomedical Technology Co., Ltd. ("He Yu Medicine"), has received FDA approval for the clinical trial application (IND) of its selective small molecule FGFR2/3 inhibitor, ABSK061, for treating children with achondroplasia (ACH) [1]. Group 1 - The IND approval from the FDA will facilitate the acceleration of ABSK061's overseas clinical development process [1]. - The drug has previously been granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) by the FDA, which supports its development in the pediatric rare disease space [1].

ABBISKO-和誉-B:FGFR2/3抑制剂ABSK061治疗儿童软骨发育不全的IND获FDA许可 - Reportify