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.
雙成藥業(002693.SZ):注射用比伐蘆定獲美國FDA仿製藥上市批准
格隆匯 10-24 18:42

格隆匯10月24日丨雙成藥業(002693.SZ)公佈,公司於近日收到美國食品和藥品監督管理局(“FDA”)的通知,公司向美國FDA提交的注射用比伐蘆定的簡化新藥申請(即仿製藥註冊申請,“ANDA”)已獲得批准。

藥品名稱:注射用比伐蘆定;劑型:注射劑;規格:250mg。

比伐蘆定是一種作用可逆的特異性凝血酶抑制劑。注射用比伐蘆定在美國獲批的適應症是作為抗凝劑用於經皮冠狀動脈介入術治療(PCI)的患者。

注射用比伐蘆定原研藥於2000年12月15日獲美國FDA的上市批准,商品名為Angiomax,申請持有人是The Medicine Company。目前美國原研產品還在專利保護期內,專利期至2029年1月27日。

注射用比伐蘆定原研藥目前在美國的申請持有人已轉變為SandozInc.,現該品種已在中國批准進口。公司的注射用比伐蘆定是與美國上市批准的產品共線生產,同步註冊申請。截至目前已獲得國家藥品監督管理局批准簽發藥品註冊批件,批准生產。

公司注射用比伐蘆定ANDA通過美國FDA批准,標誌着公司生產的注射用比伐蘆定在安全性和有效性上達到了國際水平。公司通過專利挑戰,使該產品在專利到期前提前10年進入美國市場。該產品的獲批有利於打開海外市場的佈局,為後續在美國開展仿製藥生產奠定了重要基礎,對公司未來經營業績具有積極的影響。公司後續也將積極推進該產品在美國市場的上市工作。

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