亞太藥業(002370.SZ):注射用頭孢美唑鈉通過仿製藥質量和療效一致性評價
格隆匯9月22日丨亞太藥業(002370.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於注射用頭孢美唑鈉的《藥品補充申請批准通知書》,公司注射用頭孢美唑鈉通過仿製藥質量和療效一致性評價。
頭孢美唑鈉對β-內酰胺酶高度穩定,對產β-內酰胺酶以及不產β-內酰胺酶的敏感菌具有相同的強的抗菌活性。對金黃色葡萄球菌、大腸埃希菌、肺炎桿菌、奇異變形桿菌有良好的抗菌作用,而且對耐頭孢菌素類及耐青黴素類抗生素的普通變形桿菌、摩氏摩根菌、普羅威登斯菌屬也有很強的抗菌活性。另外,頭孢美唑鈉對消化鏈球菌及擬桿菌屬、普雷沃菌屬(雙路普雷沃菌除外)等厭氧菌也顯示出很強的抗菌作用。臨牀適用於治療由對頭孢美唑鈉敏感的金黃色葡萄球菌、大腸埃希菌、肺炎桿菌、變形桿菌屬、摩氏摩根菌、普羅威登斯菌屬、消化鏈球菌屬、擬桿菌屬、普雷沃菌屬(雙路普雷沃菌除外)所引起的以下感染:敗血症、急性支氣管炎、肺炎、肺膿腫、膿胸、慢性呼吸道疾病繼發感染、膀胱炎、腎盂腎炎腹膜炎、膽囊炎、膽管炎、前庭大腺炎、子宮內感染、子宮附件炎、子宮旁組織炎、頜骨周圍蜂窩織炎、頜炎。
公司注射用頭孢美唑鈉通過仿製藥質量和療效一致性評價,有利於提升該藥品市場競爭力,同時為公司後續其他產品開展仿製藥一致性評價工作積累經驗。
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.