雙鷺藥業(002038.SZ):長效重組人胰高血糖素樣肽-1注射液獲批臨牀試驗
格隆匯11月5日丨雙鷺藥業(002038.SZ)宣佈,公司於近日收到國家藥監局簽發的關於長效重組人胰高血糖素樣肽-1注射液的《藥物臨牀試驗批准通知書》(通知書編號:2021LP01795、2021LP01796)。經審查,2021年8月23日受理的長效重組人胰高血糖素樣肽-1注射液符合藥品註冊的有關要求,同意開展2型糖尿病適應症的臨牀試驗。
長效重組人胰高血糖素樣肽-1注射液是一種胰高血糖素樣肽(GLP-1)受體激動劑,可有效治療2型糖尿病。其通過激動GLP-1受體,不僅可以促進胰島素分泌,還可減少升糖激素(胰高血糖素)的分泌,以達到降血糖的目的;還可以通過降低食慾減少葡萄糖來源,通過延緩胃排空降低餐後血糖升高幅度。
此藥品僅需每週皮下注射一次,可實現長期平穩控制血糖,並可同時降低空腹血糖與餐後血糖,顯著降低糖化血紅蛋白。它具有多種其他降糖藥物不具有的治療優勢,包括減輕體重、低血糖發生風險小等。同時,此類藥物還具有潛在的心血管獲益作用,包括降低血壓、血脂和體重以及改善脂肪肝和多囊卵巢綜合徵症狀等。
2019年2月,禮來GLP-1受體激動劑周製劑度拉糖肽(度易達®)獲批進入國內市場。目前國內已有企業類似藥品申報或獲批臨牀試驗,但未有同類產品上市。
此次公司獲得長效重組人胰高血糖素樣肽-1藥品臨牀試驗通知書,將豐富公司在糖尿病治療領域的產品儲備,與公司申報上市的達格列淨片、伏格列波糖片及處於臨牀階段的德谷胰島素注射液、門冬胰島素注射液、門冬胰島素30、50注射液、利拉魯肽等產品形成系列並滿足糖尿病患者的不同需求。
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.