仟源醫藥(300254.SZ):“利伐沙班片”獲得藥品註冊批件
格隆匯 9 月 14日丨仟源醫藥(300254.SZ)公佈,公司之子公司江蘇嘉逸醫藥有限公司(“嘉逸醫藥”)於今日收到國家藥品監督管理局簽發的化學藥品“利伐沙班片”的《藥品註冊批件》,同時原料藥利伐沙班也獲國家藥監局關聯審評通過,已批准在上市制劑中使用,該品種已列入《國家基本藥物目錄》、《國家醫保目錄》。
藥品通用名稱:利伐沙班片;劑型:片劑;規格:10mg;註冊分類:化學藥品4類;藥品標準標準編號:YBH03322020;藥品批准文號:國藥準字H20203470;藥品批准文號有效期:至2025年9月7日;藥品生產企業:江蘇嘉逸醫藥有限公司。
利伐沙班片主要用於擇期髖關節或膝關節置換手術成年患者,以預防靜脈血栓形成(VTE);成人深靜脈血栓形成(DVT),降低急性DVT後DVT復發和肺栓塞(PE)的風險;亦可用於一種或多種危險因素(例如:充血性心力衰竭、高血壓、年齡≥75歲、糖尿病、卒中或短暫性腦缺血發作病史)的非瓣膜性房顫成年患者,以降低卒中和全身性栓塞的風險。
《中國腫瘤相關靜脈血栓栓塞症預防與治療專家指南(2015版)》、《中國骨科大手術靜脈血栓栓塞症預防指南》等國內權威指南,推薦Xa因子抑制劑利伐沙班等用於預防靜脈血栓栓塞。
公司高度重視藥品研發,並嚴格控制藥品研發、製造及銷售環節的質量及安全。此次獲得利伐沙班片的藥品註冊批件,將進一步豐富公司產品結構,提高公司市場競爭力。
同時,該產品其質量、療效與原研藥品等同。根據國家相關政策,公司產品利伐沙班片按化學藥品4類批准生產可視同通過一致性評價,這將有利於擴大公司產品的市場銷售,對公司的未來經營業績產生積極的影響。
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.