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遠大醫藥(00512.HK):全球創新藥(first-in-class)STC3141獲NMPA批准進入Ib期臨牀研究
格隆匯 03-03 17:47

格隆匯 3 月 3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專注於開發抗病毒抗感染創新藥物的研發中心)正在開發的用於治療膿毒症的全球創新(“first-in-class”)藥物STC3141於2020年12月向中國國家藥品監督管理局(“NMPA”)遞交新藥臨牀試驗申請(IND)並獲得受理以來,於近日取得NMPA核准簽發的“藥物臨牀試驗批准通知書”,獲得批准在另一適應症急性呼吸窘迫綜合症(“ARDS”)中開展Ib期臨牀研究,將重點評估藥物在ARDS患者中的的安全性、耐受性和代謝特性,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。

公吿稱,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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