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.
海思科(002653.SZ):創新藥HSK3486獲得FDA上市許可申請受理

格隆匯7月31日丨海思科(002653.SZ)公佈,公司於2025年7月30日收到美國食品藥品監督管理局(FDA)下發的受理通知。根據FDA相關規定,經審查,HSK3486(環泊酚注射液)新藥上市申請(NDA)符合藥品註冊的有關要求,決定予以受理。

HSK3486(環泊酚注射液、思舒寧®)是公司開發的全新的具有自主知識產權的1類靜脈麻醉藥物,於2020年12月國內獲批上市,在國內已獲得“非氣管插管手術/操作中的鎮靜和麻醉”、“全身麻醉誘導和維持”、“重症監護期間的鎮靜”適應症的藥品註冊證書。公司於2024年完成所有臨牀研究,並完成與FDA的Pre-NDA溝通,就申報內容達成一致,獲得FDA同意進行NDA申報,於近日獲得上市許可申請受理。

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