神州細胞(688520.SH):重組人凝血因子VIII的新增兒童適應症補充申請獲得受理
格隆匯1月7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簽發的《受理通知書》,關於公司產品注射用重組人凝血因子VIII(商品名:安佳因®,產品代號:SCT800)擬新增兒童適應症的補充申請已獲得國家藥監局受理。
安佳因®為神州細胞工程自主研發的、工藝和製劑均不含白蛋白的第三代重組人凝血因子VIII產品,其用於成人及青少年(≥12歲)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的適應症已於2021年7月獲批上市。該產品也是我國首個獲批上市的國產重組人凝血因子VIII產品。
本次用於成人和兒童血友病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,止血效果好,未出現非預期的安全性問題,與進口重組凝血因子VIII國外臨牀研究文獻報道的療效和安全性結果相似。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.