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.
科伦药业(002422.SZ):甲硝唑氯化钠注射液国内首家通过一致性评价
格隆汇 03-01 12:06

格隆汇3月1日丨科伦药业(002422.SZ)宣布,公司于近日获得国家药品监督管理局核准签发的化学药品“甲硝唑氯化钠注射液”的《药品补充申请批准通知书》。经审查,该药品通过仿制药质量和疗效一致性评价。

近日公司的甲硝唑氯化钠注射液通过一致性评价并获得药品补充申请批准通知书,主要用于治疗敏感厌氧菌引起的腹腔内感染、皮肤和软组织感染、妇科感染、下呼吸道感染等严重感染以及预防择期结直肠手术的术后厌氧菌感染。

甲硝唑是全球首个上市的硝基咪唑类抗生素,为厌氧菌感染的首选药物之一,疗效确切,安全性好,临床广泛应用于呼吸科、外科、妇产科等科室,已被《抗菌药物临床应用指导原则(2015)》、《中国腹腔感染诊治指南(2019)》、《新生儿败血症诊断及治疗专家共识(2019)》、《盆腔炎症性疾病诊治规范(2019)》等国内权威指南推荐。甲硝唑氯化钠注射液为2020年国家医保目录品种,及2018年国家基药目录品种,2019年中国销售额约3.6亿元。

目前公司已有16个抗感染产品获批或通过一致性评价,且剂型和包装形式多样,已在感染性疾病领域形成优势产品集群,可为临床提供针对各种细菌、真菌、病毒感染的系统解决方案。该次公司甲硝唑氯化钠注射液国内首家通过一致性评价,将进一步丰富公司在感染性疾病领域的产品管线。

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