魯抗醫藥(600789.SH):替格瑞洛片獲得藥品註冊證書
格隆匯1月10日丨魯抗醫藥(600789.SH)公佈,近日,公司收到國家藥品監督管理局頒發的關於替格瑞洛片的《藥品註冊證書》(證書編號:2021S01335)。
替格瑞洛由阿斯利康公司研製,是第一個可逆結合的、直接起效的、口服給藥的血小板二磷酸腺苷P2Y12受體拮抗劑。本品可有效降低血液中血小板的活性,減少血栓形成的風險。2010年12月31日,替格瑞洛片在英國首次上市,此後在德國、丹麥等歐洲國家上市。國內上市規格為60mg、90mg。替格瑞洛製劑國內共24家獲批,均為片劑。根據《國家藥監局關於發佈化學藥品註冊分類及申報資料要求的通吿(2020年第44號)》,該項目屬於化學藥物4類—境內申請人仿製已在境內上市原研藥品的註冊申請。
根據IQVIA數據,替格瑞洛片2020年度在全球的銷售金額為21.0億美元(以出廠價計算),在我國境內銷售金額為20.5億元人民幣(以招標價計算)。
截至公吿披露日,公司在該藥品的研發投入約2339.05萬元人民幣(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.