石藥集團(01093.HK):抗腫瘤納米藥物“順鉑膠束注射液”獲臨牀試驗批准
格隆匯4月20日丨石藥集團(01093.HK)發佈公吿,公司附屬公司石藥集團中奇製藥技術(石家莊)有限公司開發的“順鉑膠束注射液”已獲中國國家藥品監督管理局批准,可在中國開展臨牀試驗。
根據披露,順鉑為治療多種實體瘤的一線用藥,但腎毒性、神經毒性等嚴重的不良反應限制了其臨牀應用。集團以高分子嵌段共聚物作為載體,自主開發該產品,實現了多項獨特優點,包括(i)順鉑高效裝載;(ii)減少遊離藥物在正常組織中的積累,降低毒副作用;及(iii)納米尺度的順鉑膠束可以選擇性靶向腫瘤區域,有利於提高治療指數。
臨牀前研究結果顯示:與順鉑普通製劑相比,該產品給藥後在血液中長時間以膠束形式存在,延長了順鉑在血液中的循環時間;同等劑量下,在大鼠和比格犬上的毒性反應明顯減少,且在同等劑量甚至更高劑量下耳毒性和神經毒性顯著降低,安全窗顯著提高。同時,在多種腫瘤動物模型中顯示出良好的抗腫瘤作用。
本次批准的臨牀適應症為晚期惡性實體瘤,基於臨牀前研究結果,該產品極有希望在臨牀試驗中展現出良好的效果。該產品屬於中國化藥註冊分類2類,目前全球尚無同類產品上市。集團將全力推進該產品的臨牀試驗工作,力爭該產品儘快上市。
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.