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):“複方氨基酸(16AA-II)/葡萄糖(48%)電解質注射液”獲藥品註冊證書
格隆匯 08-18 19:42

格隆匯 8 月 18日丨科倫藥業(002422.SZ)公佈,公司於近日獲得國家藥品監督管理局核准簽發的化學藥品複方氨基酸(16AA-II)/葡萄糖(48%)電解質注射液的《藥品註冊證書》。

複方氨基酸(16AA-II)/葡萄糖(48%)電解質注射液為貝朗開發的腸外營養雙室袋,臨牀適用於口服或腸內營養無法進行、不足或禁忌時,為中重度分解代謝患者提供腸外營養治療所需的氨基酸、葡萄糖營養成分目前該產品原研尚未進口公司為國內首家批准上市

腸外營養在危重、嚴重創傷等患者的救治中具有重要作用,可快速提供機體所需營養物質促進患者康復改善疾病預後。臨牀合理的腸外營養常需同時輸入脂肪乳、氨基酸和葡萄糖等營養組份,但這些營養物質必須單獨包裝才能保證穩定;另外不同患者因代謝狀況與併發疾病不同,在腸外營養治療中有特殊脂肪乳氨基酸和葡萄糖的補充需求。因此需要能實現單室袋、雙室袋和三腔袋腸外營養製劑與製造技術目前公司已經全面掌握單袋、雙室袋和三腔袋的製造技術已有針對肝功能受損、圍手術期、兒科等不同類型和能量需求患者的8產品上市。隨着後續系列品種的續貫獲批,公司將成為品類齊全、國內領先的腸外營養專業供應商。

2015國家藥監政策改革,要求新申報的仿製藥必須與原研質量和療效一致。公司本次獲批的複方氨基酸(16AA-II)/葡萄糖(48%)電解質注射液(1000ml1500ml)即是按照這一要求研發,並國內首家獲批上市。藥監局公佈的原研產品信息如下:商品名:Nutriflex special(70/240),持證商:B.Braun Medical AG

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