勵晶太平洋(00575.HK)藥物分別於中美市場 已提交試驗申請
勵晶太平洋(00575.HK)公布,中國之商業戰略夥伴江蘇萬邦醫藥已於11月16日就臨床試驗審批提交試驗性新藥,尋求中國尋求批准將 Senstend(Fortacin於中國推出市場所用的名稱)推出市面的第一步,預期可於3個月內,取得國家藥品監督管理局藥品審評中心的臨床試驗審批。
集團仍舊維持於今年底前完成Fortacin之第二階段驗證研究,並於明年上半年向美國食品及藥品監督管理局提交研究結果的目標。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能夠作為支持標示之適當措施,則至為關鍵之第三階段研究可於2021年下半年展開,並於2022年年底提交新藥申請,處方藥使用者費用法日期因此將為2023年年底。
公司仍在與中東、印度、北美及拉丁美洲地區之商業戰略夥伴進行討論。
集團領先產品Fortacin之歐洲市場推廣及分銷夥伴以意大利為基地,故集團一直在與Recordati磋商,以評估2019冠狀病毒病疫情引致之局勢及其對繼續推出Fortacin之影響。在此方面,Recordati已告知集團,於第三季度,其參考市場繼續受到2019冠狀病毒病疫情影響,原因為全境均實施遏止疫症措施,以及批發商謹慎控制存貨。Recordati表示,2019冠狀病毒病疫情將繼續影響其第四季度的銷售數字。
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