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港股異動 | 先聲藥業(2096.HK)續漲4.55% 與德國Vivoryon聯合宣佈SIM0408獲CDE批准進入臨牀實驗
格隆匯 03-01 11:55
格隆匯3月1日丨先聲藥業(2096.HK)續漲4.55%,報9.88港元,總市值260億港元。該公司2月28日與德國Vivoryon Therapeutics聯合宣佈,雙方合作在中國開發的阿爾茨海默病在研新藥SIM0408獲國家藥品監督管理局藥品審評中心(CDE)批准在中國進入臨牀試驗。SIM0408是一種差異化的AD口服小分子在研藥物,有望以獨特模式解決多個關鍵AD病理機制,涉及Aβ病理學、神經炎症和突觸損傷。其治療早期AD的全球臨牀研發已進行到臨牀Ⅱ期,在歐洲和美國分別進入Ⅱb期(VIVIAD研究)和Ⅱa/b期(VIVA-MIND 研究)。該項目於2021年12月獲得美國食品藥品監督管理局(FDA)授予的 “快速通道”資格認定,有望在全球加速審評上市。

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