瑞银发布和誉(2256.HK)速评报告。公司公布ABSK061(lavengratinib,FGFR2/3抑制剂)治疗儿童软骨发育不全(ACH)的2期初步数据。ABSK061-202为多中心、开放标签、剂量递增试验,评估每日一次口服lavengratinib用于3-12岁ACH患者,计划治疗78周。首批最低剂量队列中7名6-12岁受试者均已完成6个月治疗,前三个剂量队列的初步安全性评估未发现安全性问题。疗效方面,最低剂量队列(0.064mg/kg QD)中≥6岁儿童治疗27周后年化身高增长速度(AHV)较基线平均提高2.4厘米/年,应答率100%(定义为AHV较基线提高至少25%)。药物总体耐受性良好,未观察到FGFR1或FGFR2相关不良事件、严重不良事件或因此停药。
UBS published a First Read on Abbisko Cayman (2256.HK). The company announced preliminary Phase 2 data of ABSK061 (lavengratinib, a FGFR2/3 inhibitor) in children with achondroplasia (ACH). The ongoing ABSK061-202 trial is a multicenter, open-label, dose-escalation study evaluating once-daily oral lavengratinib in ACH patients aged 3-12 years, with a planned treatment duration of 78 weeks. All seven participants aged 6-12 years enrolled in the first and lowest dose cohort have completed six months of treatment, and preliminary safety evaluation of the first three dose cohorts has completed with no safety concerns identified to date. In the first and lowest dose cohort (0.064mg/kg QD), children aged ≥6 years achieved a mean increase of +2.4 cm/year in annualized height velocity (AHV) from baseline after 27 weeks, with a 100% responder rate (defined as achieving at least a 25% increase in AHV versus baseline). Lavengratinib was generally well-tolerated with no observed FGFR1 or FGFR2-ass