先聲藥業(02096.HK):國家藥監局簽發SIM0395(PAXALISIB)藥物臨牀試驗批准通知書
格隆匯12月7日丨先聲藥業(02096.HK)發佈公吿,公司與Kazia Therapeutics Limited(Kazia)合作的創新藥SIM0395(Paxalisib)於2021年12月6日獲得中國國家藥品監督管理局簽發的藥物臨牀試驗批准通知書,擬用於膠質母細胞瘤(GBM),包括新診斷和復發的患者。
Paxalisib是一款可透過血腦屏障的PI3K/mTOR通路抑制劑。一項Ⅱ期臨牀研究顯示,Paxalisib在MGMT非甲基化的膠質母細胞瘤患者中展現出令人鼓舞的臨牀療效信號。2021年3月,集團與Kazia簽署獨家授權合約,引進Paxalisib在大中華地區所有適應症的開發和商業化權益。
Kazia(ASX:KZA,NASDAQ:KZIA)是一家專注腫瘤藥物研發的公司,位於澳大利亞悉尼。其核心產品Paxalisib正在開展膠質母細胞瘤關鍵臨牀試驗GBMAGILE。2018年Paxalisib被美國FDA授予GBM孤兒藥認定,2020年獲美國FDA快速通道認定、瀰漫性內生型橋腦膠質瘤(DIPG)罕見兒童疾病和孤兒藥認定。
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.