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.
科倫藥業(002422.SZ):釓特醇注射液獲得藥品註冊批准
格隆匯 05-27 16:14

格隆匯5月27日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司的化學藥品“釓特醇注射液”於近日獲得國家藥品監督管理局的藥品註冊批准。

釓特醇注射液是由意大利博萊科研發的磁共振造影劑,目前已在美國、日本、歐洲等多國獲批上市,國內2014年批准進口,用於腦、脊柱和周圍組織病變的磁共振增強掃描檢查和全身磁共振檢查。

磁共振造影劑根據化學結構分為線性和環型兩類,線性磁共振造影劑更易發生腎源性系統性纖維化及腦部釓沉積導致安全性風險,因此,國際上更傾向優先推薦使用環型造影劑。釓特醇為全球首個獲批的環型磁共振造影劑,已有近30年的應用經驗,臨牀廣泛用於2歲以上兒童、成人及中重度腎功能不全等人羣的造影,已被中國《腎病患者靜脈注射釓對比劑應用中國專家共識(2022)》、《釓對比劑臨牀安全性應用中國專家建議(2019)》、美國《對比劑應用手冊(2021)》等國內外權威指南或共識推薦使用。

釓特醇注射液為公司在診斷造影領域繼碘帕醇注射液和釓塞酸二鈉注射液後第3個獲批的品種,為國內首仿獲批,未來將與公司已申報的釓布醇注射液及在研的系列X射線、磁共振和超聲造影劑,共同形成診斷造影領域的優勢產品集羣。

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