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遠大醫藥(00512.HK):全球創新產品STC3141在比利時獲批開展與COVID-19相關的IIa期臨牀研究
格隆匯 04-19 17:59

格隆匯 4 月 19日丨遠大醫藥(00512.HK)發佈公吿,集團全資擁有附屬公司Grand Medical Pty Ltd(一間集團在澳洲設立的創新藥研發中心)正在開發,用於重症感染領域的全球創新藥物STC3141,日前已獲得批准在比利時開展用於治療2019冠狀病毒病(COVID-19)的IIa期臨牀研究。

此次STC3141獲批在比利時開展治療COVID-19的IIa期臨牀研究,將在至少3個研究中心入組25名患者開展隨機開放式單臂研究,旨在研究和評估藥物在治療因感染COVID-19所引發的病毒性肺炎重症患者中的安全性和有效性,進一步擴大產品的適用範圍,積累更多資料綜合評估後期臨牀試驗的風險和獲益,以加快產品的全球開發進程。

重症抗感染領域為集團核心戰略領域之一,STC3141為全新作用機制的全球創新產品,通過中和胞外組蛋白和中性粒細胞誘捕網來逆轉機體過度免疫反應造成的器官損傷,可用於多種重症適應症,如膿毒症和急性呼吸窘迫綜合症(ARDS)等臨牀上死亡率高而沒有有效治療手段的疾病。該產品作用機制新穎,臨牀前相關研究結果已於2020年2月發表於頂級學術期刊“Nature Communications”,具有深遠的學術影響力。而臨牀研究方面,該產品已分別於2020年5月在澳洲獲批開展用於治療感染COVID-19患者ARDS的II期臨牀研究和用於治療膿毒症的Ib期臨牀研究,於今年3月初獲得中國國家藥品監督管理局(NMPA)的批准,在ARDS患者中開展Ib期臨牀研究。此次獲批在比利時開展治療COVID-19的IIa期臨牀研究,是該項目的研發工作中又一重要里程碑。

集團一直高度重視創新產品和先進技術的研發,以患者需求為核心,以科技創新為驅動,針對尚未滿足的臨牀需求,加大對全球創新產品和先進技術的投入,豐富和完善產品管線及產業佈局,採用“全球化運營佈局,雙循環經營發展”策略,形成國內國際雙循環聯動發展並相互促進的新格局,充分發揮集團的產業優勢和研發實力,快速將科技創新產品落地上市,為全球患者提供更先進更多樣的治療方案。

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