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远大医药(00512.HK):全球创新产品STC3141在比利时获批开展与COVID-19相关的IIa期临床研究
格隆汇 04-19 17:59

格隆汇 4 月 19日丨远大医药(00512.HK)发布公告,集团全资拥有附属公司Grand Medical Pty Ltd(一间集团在澳洲设立的创新药研发中心)正在开发,用于重症感染领域的全球创新药物STC3141,日前已获得批准在比利时开展用于治疗2019冠状病毒病(COVID-19)的IIa期临床研究。

此次STC3141获批在比利时开展治疗COVID-19的IIa期临床研究,将在至少3个研究中心入组25名患者开展随机开放式单臂研究,旨在研究和评估药物在治疗因感染COVID-19所引发的病毒性肺炎重症患者中的安全性和有效性,进一步扩大产品的适用范围,积累更多资料综合评估后期临床试验的风险和获益,以加快产品的全球开发进程。

重症抗感染领域为集团核心战略领域之一,STC3141为全新作用机制的全球创新产品,通过中和胞外组蛋白和中性粒细胞诱捕网来逆转机体过度免疫反应造成的器官损伤,可用于多种重症适应症,如脓毒症和急性呼吸窘迫综合症(ARDS)等临床上死亡率高而没有有效治疗手段的疾病。该产品作用机制新颖,临床前相关研究结果已于2020年2月发表于顶级学术期刊“Nature Communications”,具有深远的学术影响力。而临床研究方面,该产品已分别于2020年5月在澳洲获批开展用于治疗感染COVID-19患者ARDS的II期临床研究和用于治疗脓毒症的Ib期临床研究,于今年3月初获得中国国家药品监督管理局(NMPA)的批准,在ARDS患者中开展Ib期临床研究。此次获批在比利时开展治疗COVID-19的IIa期临床研究,是该项目的研发工作中又一重要里程碑。

集团一直高度重视创新产品和先进技术的研发,以患者需求为核心,以科技创新为驱动,针对尚未满足的临床需求,加大对全球创新产品和先进技术的投入,丰富和完善产品管线及产业布局,采用“全球化运营布局,双循环经营发展”策略,形成国内国际双循环联动发展并相互促进的新格局,充分发挥集团的产业优势和研发实力,快速将科技创新产品落地上市,为全球患者提供更先进更多样的治疗方案。

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