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普洛藥業(000739.SZ):家園藥業終止注射用索法地爾III期臨牀試驗
格隆匯 01-26 20:52

格隆匯1月26日丨普洛藥業(000739.SZ)公佈,公司全資子公司浙江普洛家園藥業有限公司(簡稱“家園藥業”)研發的注射用索法地爾治療急性缺血性腦卒中的臨牀研究處於III期臨牀試驗階段。近日,基於該藥物目前臨牀研究進展及後續研發投入等因素的綜合評估,公司決定終止注射用索法地爾治療急性缺血性腦卒中的III期臨牀試驗。

注射用索法地爾是公司全資子公司家園藥業開發的一種創新藥物,臨牀試驗的適應症為:急性缺血性腦卒中。家園藥業於2009年從韓國Neurotech公司(現名:GNTPharma)引進注射用索法地爾項目,具有大中華地區的自主知識產權。

經公司評估,結合III期臨牀試驗運行期間全國大範圍封控影響,可能導致臨牀研究數據的完整性和準確性風險以及方案偏離可能引起的數據質量風險,公司決定終止該III期臨牀試驗。該項臨牀試驗的終止不影響注射用索法地爾在GNTPharma的臨牀研究以及公司未來該項目的其他相關臨牀研究。

臨牀試驗終止後,該臨牀試驗將停止入組,已經入組的受試者將繼續按照臨牀試驗方案進行隨訪,已入組受試者的權益將得到充分保障。

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