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博暉創新(300318.SZ):靜注人免疫球蛋白獲得藥品註冊證書
格隆匯 07-27 16:27

格隆匯 7 月 27日丨博暉創新(300318.SZ)公佈,公司控股公司河北大安製藥有限公司(“河北大安”)研發的靜注人免疫球蛋白(pH4)近日收到國家藥品監督管理局核准簽發《藥品註冊證書

河北大安研發的靜注人免疫球蛋白(pH4)主要適用於原發性免疫球蛋白缺乏症,如X 聯鎖低免疫球蛋白血癥、常見變異性免疫缺陷病、免疫球蛋白G 型缺陷病等;繼發性免疫球蛋白缺陷病,如重症感染、新生兒敗血症等;自身免疫性疾病,如原發性血小板減少性紫癜、川崎病等。

河北大安本次獲批的靜注人免疫球蛋白(pH4)系國內首次根據《藥品註冊管理辦法》進行了完整臨牀研究和相關毒理研究的靜注人免疫球蛋白產品。產品生產是國內首家採用國際通行最先進的20nm級納米膜過濾器去除病毒,對顆粒較大的脂包膜病毒和顆粒較小的非脂包膜病毒均具有良好的去除作用,能較好的確保產品病毒安全性。臨牀研究結果顯示對相關適應症臨牀療效較好;通過對產品的lgG亞類分析測定,製品中IgG亞類齊全,且比例與正常人血清的IgG亞類分佈接近。

靜注人免疫球蛋白屬於血液製品的重要品種,上述註冊證的取得豐富了河北大安血液製品產品的種類,將提高河北大安血漿的利用效率,對河北大安未來業績的提升具有重要的意義。但鑑於血液製品的生產和銷售特點,預計不會對河北大安及公司本年度業績產生重大影響。

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