You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
人福醫藥(600079.SH):鹽酸納布啡注射液新增適應症申報生產獲得受理
格隆匯 01-12 16:34

格隆匯1月12日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福藥業有限責任公司(“宜昌人福”,公司持有其80%的股權)近日收到國家藥品監督管理局核准簽發的鹽酸納布啡注射液申報生產的《受理通知書》。

鹽酸納布啡注射液於2013年獲批上市,獲批適應症為“作為鎮痛藥用於複合麻醉時的麻醉誘導”,宜昌人福於2022年12月向國家藥品監督管理局藥品審評中心遞交了本次新增適應症“作為鎮痛藥用於術後鎮痛以及產科鎮痛”的上市許可申請並獲得受理,截至目前該項目累計研發投入約人民幣2700萬元。

根據國家藥品監督管理局網站顯示,國內共有3家企業獲得鹽酸納布啡注射液的生產批文。目前,鹽酸納布啡注射液的主要生產廠商為宜昌人福,宜昌人福2021年度鹽酸納布啡注射液的銷售額為5.88億元。

鹽酸納布啡注射液申報生產被國家藥品監督管理局受理,標誌着該品種新適應症的相關藥品註冊工作進入了審評階段,公司將積極推進後續相關工作,如順利通過審評審批,將豐富公司的產品線,有利於提升公司的市場競爭力。

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.
uSMART
Wealth Growth Made Easy
Open Account