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.
澤璟製藥(688266.SH):甲苯磺酸多納非尼片擬納入優先審評審批程序
格隆匯 10-12 15:49

格隆匯 10 月 12日丨澤璟製藥(688266.SH)公佈,公司1類抗腫瘤新藥甲苯磺酸多納非尼片(“多納非尼”)近日被國家藥品監督管理局藥品審評中心納入擬優先審評審批品種公示名單,公示期7日。

甲苯磺酸多納非尼片是公司開發的口服多靶點、多激酶抑制劑類小分子抗腫瘤藥物,屬於1類新藥,公司擁有獨立的自主知識產權。臨牀前藥理學研究證實,多納非尼既可抑制VEGFRPDGFR等多種受體酪氨酸激酶的活性,也可直接抑制各種Raf激酶,並抑制下游的Raf/MEK/ERK信號傳導通路,抑制腫瘤細胞增殖和腫瘤血管的形成,發揮多重抑制、多靶點阻斷的抗腫瘤作用。20205納非尼用於治療晚期(無法手術或轉移性)肝細胞癌適應症的新藥上市申請(NDA)獲得國家藥品監督管理局受理,本次新藥上市申請主要是基於甲苯磺酸多納非尼片一線治療晚期肝細胞癌的開放、隨機、平行對照、多中心II/III期臨牀研究(試驗代號ZGDH3)的結果

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