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.
華北製藥(600812.SH):苯磺酸左氨氯地平片(2.5mg、5mg)通過仿製藥一致性評價
格隆匯 02-10 17:55

格隆匯2月10日丨華北製藥(600812.SH)公佈,近日,,公司收到國家藥品監督管理局核准簽發苯磺酸左氨氯地平片(2.5mg、5mg)的《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價。

苯磺酸左氨氯地平為苯磺酸氨氯地平的純手性成分,目前美國、日本及歐盟地區尚未有產品獲批上市。印度(商品名:Eslo,Asomex和Espin)、俄羅斯(商品名:EsCordi Cor)和巴西(商品名:Novanlo)有苯磺酸左氨氯地平片銷售,尚未進口中國。

苯磺酸左氨氯地平片屬於鈣通道阻滯藥。臨牀適用於高血壓和心絞痛的治療。

目前國內共有15個苯磺酸左氨氯地平片的生產批件、沒有進口批件,批准規格包括2.5mg、5mg。公司為國內第六家通過苯磺酸左氨氯地平片(2.5mg、5mg)一致性評價的企業。

開展一致性評價工作以來,公司該產品累計研發投入1590.79萬元人民幣(未經審計)。

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