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.
首藥控股(688197.SH):SY-3505(CT-3505)膠囊獲得II期臨牀試驗倫理審批報吿
格隆匯 08-01 16:41

格隆匯8月1日丨首藥控股(688197.SH)公佈,公司於近日收到中國醫學科學院腫瘤醫院倫理委員會出具的關於“CT-3505膠囊治療ALK陽性非小細胞肺癌患者的I/II期臨牀試驗(CT-3505-I-01)”修改案審批報吿,該院倫理委員會認為該項目的修改案基本符合倫理要求,可以在臨牀研究中使用(注:公司自2016年起使用“SY”進行編號命名自研管線,由於SY-3505申請和開展臨牀試驗的時間較早,在國家藥品監督管理局頒發的臨牀試驗通知書中使用的名稱為CT-3505)。

SY-3505是由公司完全自主研發的第三代ALK激酶抑制劑,已於2019年7月2日取得臨牀試驗通知書,系國內第一個進行臨牀試驗的國產三代ALK抑制劑,主要用於治療一、二代ALK抑制劑耐藥的ALK陽性非小細胞肺癌。

SY-3505能夠抑制野生型ALK激酶和若干關鍵耐藥突變體(如F1174L、L1196M、G1202R、G1269S、R1275Q等)的活性,阻斷其信號傳導通路,最終實現抑制腫瘤生長的效果。經查詢,目前全球僅有一款三代ALK抑制劑Lorlatinib(勞拉替尼)獲批上市,我國一、二代ALK抑制劑耐藥的ALK陽性非小細胞肺癌患者存在未被滿足的臨牀需求。

SY-3505作為國內首個進入臨牀研究的國產三代ALK抑制劑,I期臨牀試驗共納入62例受試者,已有數據顯示SY-3505具有良好的安全性和藥代動力學特徵,在耐藥患者(尤其是二代耐藥患者)體內表現出了明顯的抗腫瘤活性。此次獲得倫理審批報吿後,公司將盡快正式啟動評價SY3505膠囊治療晚期ALK陽性非小細胞肺癌的療效和安全性的II期臨牀研究工作。

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