Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its FGFR2/3 inhibitor ABSK061. The approval paves the way for a multi-center, non-randomized, open Phase I/II study to evaluate the drug’s safety, tolerability, pharmacokinetics, and efficacy in children with achondroplasia (ACH).
Clinical Trial Design
The study will assess the oral FGFR2/3 inhibitor in pediatric patients with ACH, a rare genetic disorder characterized by asymmetric short stature and the most common form of dwarfism in humans. Currently, there is no etiological treatment available for ACH in China, highlighting the significance of this trial.-Fineline Info & Tech
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