賽生藥業(06600.HK)：國家藥監局受理DANYELZA® (那西妥單抗)及GM-CSF聯合伊立替康及替莫唑胺用於原發難治性或首次復發高危神經母細胞瘤患者的IND
格隆匯4月20日丨賽生藥業(06600.HK)發佈公吿，國家藥監局藥品審評中心已受理公司DANYELZA® (那西妥單抗)及粒細胞 — 巨噬細胞集落刺激因子(“GMCSF”)聯合伊立替康及替莫唑胺用於原發難治性或首次復發的高危神經母細胞瘤患者的研究性新藥(“IND”)申請(“203號研究”)。203號研究是一項國際、單臂、多中心的II期臨牀試驗。倘203號研究於中國獲批，這也將是中國研究中心首次參與神經母細胞瘤免疫治療的國際多中心臨牀研究。
神經母細胞瘤是一種罕見的癌症，但也是兒童期最常見的顱外實體瘤。儘管一線多模式治療取得進展，但仍有約60%的高危神經母細胞瘤患者於完成傳統治療後復發。幾十年來，復發後結局一直欠佳，10年總生存率低於15%。針對兒童癌症創新療法╱國際兒科腫瘤學會歐洲神經母細胞瘤小組開展的三項II期試驗(71例患者)進行的薈萃分析顯示，所有患者、原發難治性及疾病復發患者的中位無進展生存期(mPFS)分別為6.4、12.5及5.7個月，而相應的中位總生存期(m-OS)分別為16.1、27.9及11.0個月。因此，原發難治性或疾病復發的高危神經母細胞瘤患者在更有效及創新的治療方面仍存在高度未滿足的醫療需求，集團致力快速推進臨牀試驗(倘獲批准)，以儘快滿足該等患者的需求。
DANYELZA® (那西妥單抗)為唯一一款獲批靶向神經節苷脂GD2的人源化單克隆抗體。GD2是一種神經母細胞瘤細胞表面的腫瘤抗原。其被美國食品藥品監督管理局根據22位患者的II期臨牀試驗(“201號研究”)授予優先評審，獲得突破治療和孤兒藥資格，並基於總體緩解率(overall response rate, ORR)和緩解持續時間(duration of response, DOR)於2020年11月獲得其加速批准。
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.
