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):鹽酸多塞平膠囊獲得美國FDA批准文號
格隆匯 10-21 15:59

格隆匯10月21日丨人福醫藥(600079.SH)宣佈,近日,公司全資子公司Epic Pharma收到美國食品藥品監督管理局(FDA)關於鹽酸多塞平膠囊的批准文號。鹽酸多塞平膠囊用於治療抑鬱症及焦慮性神經症。

Epic Pharma於2017年提交鹽酸多塞平膠囊的ANDA申請,累計研發投入約為130萬美元。根據IQVIA數據統計,2019年該藥品在美國市場的總銷售額約為4800萬美元,主要生產廠商包括Aurobindo、Amneal和Mylan等。

根據米內網數據統計,2019年度多塞平片劑在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為1000萬元人民幣,主要生產廠商包括上海上藥信誼藥廠有限公司、仁和堂藥業有限公司、蘇州弘森藥業股份有限公司等。

該次鹽酸多塞平膠囊獲得美國FDA批准文號標誌着Epic Pharma具備了在美國市場銷售該產品的資格,將對公司拓展美國仿製藥市場帶來積極的影響,公司後續將積極推進該產品在美國市場的上市準備工作。

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