瑞博生物治疗丁型肝炎病毒感染的小核酸药物RBD1016获EMA孤儿药资格认定

智通财经

Oct 24

智通财经APP获悉，苏州瑞博生物技术股份有限公司(“瑞博生物”)及其子公司Ribocure Pharmaceuticals AB (“Ribocure”)共同宣布欧洲药品管理局(EMA)授予其小干扰RNA(siRNA)候选药物RBD1016孤儿药资格认定(Orphan Drug Designation, ODD)，用于治疗丁型肝炎病毒(HDV)的感染。

EMA的孤儿药资格认定旨在鼓励在欧盟发病率低于万分之五、导致严重威胁生命或慢性衰竭性罕见病的在研疗法。孤儿药资格为创新药物提供了更优的监管通路和商业化激励政策，从而能更快地惠及患者。瑞博生物自主研发的RiboGalSTARTM肝靶向递送平台的安全性、有效性和长效性已通过多项临床研究得以验证，其中包括用于治疗HDV适应症的RBD1016，目前该药物正在全球同步推进乙肝和丁肝的II期临床试验。

瑞博生物联席CEO兼全球研发总裁甘黎明博士表示：“本次孤儿药认定是RBD1016药物研发的重要里程碑，将显著提升RBD1016的开发与商业化前景。它验证了我们通过创新RNAi技术，攻克具有高度未满足临床需求的严重疾病的战略。我们正全力推进这款药物的临床研究，致力于为受这一罕见病困扰的患者提供全新的治疗方案。很高兴看到RBD1016为尚无有效治疗选择的HDV患者带来了希望。”

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