金城醫藥(300233.SZ):注射用頭孢曲松鈉通過一致性評價
格隆匯 3 月 2日丨金城醫藥(300233.SZ)公佈,公司於2021年3月2日收到控股子公司廣東金城金素製藥有限公司(“金城金素”)的通知,金城金素於2021年3月2日收到藥監局核准簽發的注射用頭孢曲松鈉《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。
頭孢曲松鈉為長效、廣譜的第三代頭孢菌素類抗生素,較第一、二代頭孢菌素對革蘭氏陰性菌活性與β-內酰胺酶穩定性增強;與其他第三代頭孢菌素相比,具有半衰期長、組織穿透力強、毒副作用小等優勢,臨牀上一般用於治療敏感菌所致的腦膜炎、腹部感染、骨和關節感染、皮膚和軟組織感染、包括淋病在內的生殖感染、腎臟和泌尿道感染以及術前感染等。該藥品最早由瑞士Roche公司研發,於1982年首次在瑞士上市,在1984年獲得美國FDA批准。
注射用頭孢曲松鈉為國家醫保甲類目錄品種及國家基本藥物目錄品種。公司注射用頭孢曲松鈉最早於2004年4月30日獲得原國家食品藥品監督管理局藥品註冊批件,藥品規格:0.25g(國藥準字H20043826);0.5g(國藥準字H20043827);1.0g(國藥準字H20043825)。
金城金素注射用頭孢曲松鈉通過仿製藥質量和療效一致性評價,有利於進一步提升該產品的市場競爭力,併為後續產品開展仿製藥一致性評價工作積累寶貴經驗。
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.