海思科(002653.SZ):收到創新藥HSK3486補充資料通知
格隆匯3月23日丨海思科(002653.SZ)公佈,公司於近日收到國家藥品監督管理局藥品審評中心下發的《補充資料通知》(藥審補字[2020]第0539號、藥審補字[2020]第0540號)。
審評中心對公司申報的HSK3486及HSK3486乳狀注射液(受理號為CXHS1900019和CXHS1100020)進行了技術審評,要求公司完善該品種有關安全性、有效性或/和質量控制的內容,並於2020年7月27日之前提交至審評中心。公司表示,公司將根據《補充資料通知》的要求儘快向審評中心提供相關資料。
據悉,HSK3486乳狀注射液於2019年7月獲得國家藥品監督管理局受理“消化道內鏡診斷和治療鎮靜和/或麻醉”適應症的新藥申請(特殊審批程序)(受理號:CXHS1900019/CXHS1900020),並於2019年08月被納入優先評審;於2020年1月獲得國家藥品監督管理局受理“全身麻醉誘導”適應症新藥申請(特殊審批程序)(受理號:CXHS2000001),並於2020年02月被納入優先評審。
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.