美諾華(603538.SH):子公司獲普瑞巴林膠囊藥品註冊批件
格隆匯12月15日丨美諾華(603538.SH)公佈,公司參股子公司寧波科爾康美諾華藥業有限公司(以下簡稱“科爾康美諾華”)於近日收到國家藥監局核准簽發的“普瑞巴林膠囊”(以下簡稱“普瑞巴林”)《藥品註冊證書》。
普瑞巴林用於治療帶狀皰疹後神經痛、纖維肌痛。根據IQVIA數據顯示,普瑞巴林膠囊2019年全球銷售額約78億美元,中國銷售額約2.28億元人民幣。該藥品已被列入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2019年版)》和《國家基本藥物目錄(2018年版)》。
該藥品的獲批主體科爾康美諾華是公司與戰略客户KRKA本着資源共享、優勢互補、互利互惠、長遠戰略合作的原則,為深入開展製劑領域合作而在國內共同設立的合資公司,公司持股佔比40%。以合資公司為主體並作為藥品上市許可持有人(MAH),以公司全資子公司美諾華天康為生產廠商,雙方協力將KRKA在歐洲已上市產品進行國內轉報,推動其製劑產品在國內市場的開拓。上述合作在實現公司原料藥和製劑CMO業務持續穩定增長的同時,將拓寬豐富公司的製劑管線,加速提升自身生產、銷售與研發能力,進一步推進公司製劑一體化轉型。
普瑞巴林膠囊是合作以來科爾康美諾華第一個獲批的製劑品種。本次普瑞巴林膠囊獲得國家藥監局《藥品註冊證書》,標誌着科爾康美諾華獲得了該藥品在國內市場生產、銷售的資格,是雙方合作的重要進展,對公司經營發展具有積極的作用。
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.