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通化東寶(600867.SH):超速效賴脯胰島素注射液申報臨牀獲得批准
格隆匯 11-22 15:09

格隆匯 11 月 22日丨通化東寶(600867.SH)公佈,公司申報的超速效賴脯胰島素注射液(THDB0206)(受理號CXSL2000266國、CXSL2000267國)藥品註冊申請,於近日收到國家藥品監督管理局核准簽發的藥物臨牀試驗批准通知書。

截至公告日,公司在該項目中已投入研發費用人民幣約2,758.75萬元。

通化東寶2018年4月26日與法國SA ADOCIA公司(以下簡稱"Adocia公司")簽訂了《超速效型胰島素合作和許可協議》,Adocia公司將BioChaperone的專利平台技術、專利權有償許可給通化東寶,通化東寶利用該等專利平台技術,獲得許可產品BC Lispro (BC賴脯胰島素),即超速效賴脯胰島素注射液(THDB0206),在大中華地區的國家和地區,以及馬來西亞、新加坡等國家和地區的獨家臨牀開發、生產和商業化權利。

通化東寶從2018年5月開始進行技術轉移和進一步開發,2020年7月完成了申請臨牀試驗所需的全部藥學和非臨牀研究,2020年8月25日將臨牀試驗申請的全套註冊資料郵寄至CDE,2020年9月14日收到國家藥品監督管理局藥品審評中心簽發的關於超速效賴脯胰島素注射液(THDB0206)藥品申報臨牀申請受理通知書。

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