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.
中國醫藥(600056.SH):那格列奈片兩個規格通過仿製藥一致性評價
格隆匯 03-26 16:45

格隆匯 3 月 26日丨中國醫藥(600056.SH)公佈,近日,公司下屬子公司天方藥業有限公司(“天方有限”)獲得國家藥品監督管理局(“國家藥監局”)核准簽發的那格列奈片兩個規格《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。

那格列奈屬於D-苯丙氨酸衍生物,是繼瑞格列奈後的第2個新型非磺脲類口服降糖藥,通過刺激胰島β細胞分泌胰島素而發揮作用。那格列奈由日本味之素、山之內與Rousel-Morishifa公司共同開發,1999年8月首先在日本上市,上市規格為30mg、90mg。隨後,味之素公司將那格列奈片在全球(除日本和韓國)的上市許可持有權交給NOVARTIS(諾華)公司,2000年12月諾華的那格列奈片(60mg、120mg)經FDA批准在美國上市,商品名為STARLIX。

那格列奈片可以單獨用於經飲食和運動不能有效控制高血糖的2型糖尿病病人。也可用於使用二甲雙胍不能有效控制高血糖的2型糖尿病病人,採用與二甲雙胍聯合應用,但不能替代二甲雙胍。

截至公吿披露日,該藥品研發費用投入約1510萬元人民幣。經查詢國家藥監局網站顯示,截至公吿披露日,目前國內生產廠家江蘇德源藥業股份有限公司(120mg)、珠海同益製藥有限公司(60mg)通過該藥品的一致性評價。該藥品為《國家基本醫療保險、工傷保險和生育保險目錄(2020年)》乙類藥品。根據第三方數據庫PDB查詢顯示,該藥品2020年國內樣本醫院銷售額約為1543萬元。公司該藥品2020年未經審計銷售收入約為500萬元。

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