雙成藥業(002693.SZ):注射用比伐蘆定通過注射劑質量和療效一致性評價
格隆匯 12 月 30日丨雙成藥業(002693.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的注射用比伐蘆定的《藥品補充申請批准通知書》。公司產品注射用比伐蘆定已通過注射劑仿製藥質量和療效一致性評價(“一致性評價”)。
比伐蘆定是一種作用可逆的特異性凝血酶抑制劑。注射用比伐蘆定的適應症是作為抗凝劑用於成人經皮冠狀動脈腔內成形術(PTCA)和經皮冠狀動脈介入治療(PCI),以及用於PCI中有由肝素引起血小板減少(HIT)或有由肝素引起血小板減少和血栓綜合症(HITTS)風險的病人。
公司於2019年01月29日向國家藥品監督管理局藥品審評中心遞交了注射用比伐蘆定一致性評價申請,於2019年02月12日獲得受理。
截至公吿披露日,公司取得注射用比伐蘆定一致性評價,累計研發投入金額為人民幣2944.36萬元(未經審計)。
注射用比伐蘆定通過一致性評價,證明公司該產品在質量和療效上與原研藥品一致,同時為公司後續產品開展一致性評價工作積累了寶貴經驗。
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