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博雅生物(300294.SZ):人血管性血友病因子獲批臨牀
格隆匯 08-06 17:40

格隆匯8月6日丨博雅生物(300294.SZ)公佈,近日,公司收到國家藥監局出具的《藥物臨牀試驗批准通知書》(通知書編號:2021LP01227),公司申報的人血管性血友病因子(每瓶含人血管性血友病因子500IU、人凝血因子Ⅷ200IU)(受理號:CXSL2101101國)臨牀試驗申請已獲批准。

人血管性血友病因子(vWF)是一種重要的血漿成分。當人體受傷時,其介導血小板在損傷部位的粘附和聚集,產生止血。同時vWF也是凝血因子Ⅷ的運輸劑和穩定劑。

vWF產品用於治療血管性血友病(von Willebrand disease,vWD)患者的自發和創傷性出血,是血管性血友病患者的特效藥。截至目前,國內尚無人血管性血友病因子產品在市面銷售。

截至目前,公司人血管性血友病因子累計研發投入3339.15萬元。

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