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勵晶太平洋(00575.HK)治療早洩藥Fortacin將再邀請額外研究對象
阿思達克 06-18 16:54
勵晶太平洋(00575.HK)公布,儘管因美國及世界各地爆發2019冠狀病毒疫情及近期反種族歧視主義遊行導致面對困難,集團就有關其Fortacin之第二階段驗證研究向美國食品及藥品監督管理局申請批准一事上仍繼續取得穩定進展。截至今年6月14日,另23名研究對象接受篩選並收到日記作為第二階段研究之一部分,而有一名研究對象屬隨機選擇。集團之目標是於今年8月1日前再邀請額外44至47名人士作為研究對象,旨在使額外53名完整研究對象隨機化,令驗證研究的隨機化完整研究對象達到合共100名。

集團指,倘主要中心如所述般成功完成隨機化,則集團將按照計劃於今年底前完成Fortacin之第二階段驗證研究。然而,倘在所需對象之招募及隨機化上遇到任何延誤,則將會使研究延遲完成。假設試驗足以說服美國食品及藥品監督管理局就早洩煩惱評價調查問卷(早洩煩惱評價調查問卷)能夠作為支持標示之適當措施,則至為關鍵之第三階段工作可於今年下半年展開,並於明年上半年提交新藥申請,處方藥使用者費用法日期因此將為2023年第一季。

至於中國之審批及商業化進展,集團正與中國之商業戰略夥伴江蘇萬邦醫藥就申請監管批准一事上繼續取得進展。假設可按時間表提交試驗性新藥,則可於今年第四季至明年第一季之期間內獲得臨床試驗審。

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