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神州細胞(688520.SH):重組人凝血因子VIII(安佳因®)新增兒童適應症補充申請獲得批准
格隆匯 02-02 16:42

格隆匯2月2日丨神州細胞(688520.SH)公佈,近日,公司控股子公司神州細胞工程有限公司(“神州細胞工程”)收到國家藥品監督管理局(“國家藥監局”)簽發的《藥品補充申請批准通知書》,公司產品注射用重組人凝血因子VIII(商品名:安佳因®)擬新增12歲以下兒童適應症的補充申請已獲得國家藥監局批准。

此次為12歲以下兒童血友病A(先天性凝血因子Ⅷ缺乏症)患者出血的控制和預防適應症的補充申請,主要是基於一項多中心、開放、非對照,評估重組人凝血因子Ⅷ(SCT800)在既往接受過凝血因子Ⅷ治療的重型甲型血友病兒童患者(<12歲)中預防性治療的有效性、安全性和藥代動力學的III期臨牀試驗的結果。該項臨牀試驗結果符合預期,年化出血率低,止血效果好,未出現非預期的安全性問題。

根據國家藥監局網站數據查詢,目前國內已上市6款進口重組凝血因子VIII產品和1款國產重組凝血因子VIII產品,分別為拜耳公司的拜科奇®和科躍奇®、百特公司的百因止®、輝瑞公司的任捷®、諾和諾德公司的諾易®、韓國綠十字公司的綠茵芷®和神州細胞工程的安佳因®。其中,拜科奇®、科躍奇®、百因止®、任捷®、諾易®已經取得兒童適應症的上市許可。

此次安佳因®新增兒童適應症的補充申請獲得批准,有助於更好地滿足兒童患者的用藥需求,進一步提高公司產品的市場競爭力和市場佔有率,對公司未來營業收入的增長具有積極影響。

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