【舒泰神:注射用STSP-0601纳入优先审评程序】金十数据6月5日讯,舒泰神公告,子公司江苏贝捷泰生物科技有限公司的产品注射用STSP-0601于2025年05月26日被国家药品监督管理局药品审评中心纳入拟优先审评品种公示名单,2025年06月05日正式纳入优先审评程序。注射用STSP-601是国家1类治疗用生物制品,用于治疗伴抑制物的血友病A或B患者出血按需治疗。该药品在2021年09月启动在伴抑制物血友病患者中的Ib/II期临床试验,2022年09月获得突破性治疗品种认定。2024年3月启动了一项针对伴抑制物的血友病患者出血按需治疗的IIb期临床试验,结果表明出血按需治疗的疗效显著。
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