立方製藥(003020.SZ):二甲雙胍格列吡嗪片一致性評價申請獲得受理
格隆匯2月9日丨立方製藥(003020.SZ)公佈,近日,公司收到國家藥品監督管理局下發的二甲雙胍格列吡嗪片一致性評價申請《受理通知書》。
二甲雙胍格列吡嗪片是二甲雙胍和格列吡嗪的複方製劑,用於飲食、運動療法不能充分有效控制血糖的2型糖尿病患者。原研廠家為百時美施貴寶公司,目前國內無原研進口產品上市。公司二甲雙胍格列吡嗪片於2009年獲批上市,批准文號為國藥準字H20090086,規格為每片含鹽酸二甲雙胍250mg與格列吡嗪2.5mg。截至公吿日,國內此規格二甲雙胍格列吡嗪片暫無企業仿製品種通過/視同通過質量與療效一致性評價,其他規格(每片含鹽酸二甲雙胍500mg與格列吡嗪2.5mg)有1家公司仿製品種通過質量與療效一致性評價。
二甲雙胍格列吡嗪片一致性評價申請獲得受理,表示該品種一致性評價工作進入了註冊審評階段。如該品種順利通過一致性評價審評,將有益於提升其市場競爭力。
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.