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博暉創新(300318.SZ):凍幹人用狂犬病疫苗(無血清Vero細胞)獲批臨牀試驗
格隆匯 07-23 16:53

格隆匯 7 月 23日丨博暉創新(300318.SZ)公佈,公司控股孫公司中科生物製藥股份有限公司(“中科生物”)與成都柏奧特克生物科技股份有限公司(“柏奧特克”)於2020年1月簽訂《項目合作合同》,聯合申報凍幹人用狂犬病疫苗(無血清Vero細胞)產品。該產品於近日收到國家藥品監督管理局核准簽發《藥物臨牀試驗批准通知書》。

藥物名稱:凍幹人用狂犬病疫苗(無血清Vero細胞);劑型:注射劑(凍乾粉針劑);規格:復溶後每瓶1.0ml;註冊分類:預防用生物製品,第15類;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,批准本品按照提交的方案開展臨牀試驗。

中科生物與柏奧特克聯合申報的凍幹人用狂犬病疫苗(無血清 Vero細胞),系用狂犬病病毒固定毒株接種無血清Vero細胞製成,具有無血清、無動物源性成分添加的特點,能有效避免產品使用時產生過敏、發熱等不良反應。

適應症為:凡被狂犬或其他瘋動物、抓傷時,按暴露後免疫程序注射本疫苗凡有接觸狂犬病病毒危險的人員按暴露前免疫程序注射本疫苗。

上述產品臨牀試驗批准通知書的取得不會對公司近期業績產生重大影響。該產品臨牀試驗、審評和審批的結果以及時間都具有一定的不確定性。敬請廣大投資者謹慎決策,注意投資風險。

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