長春高新(000661.SZ):子公司GenSci120注射液新藥臨牀試驗申請獲得美國FDA默示許可
格隆匯3月20日丨長春高新(000661.SZ)公佈,近日,長春高新技術產業(集團)股份有限公司控股子公司長春金賽藥業有限責任公司(簡稱“金賽藥業”)收到美國食品藥品監督管理局(簡稱“美國FDA”)通知,金賽藥業GenSci120注射液新藥臨牀試驗申請獲得默示許可。
GenSci120注射液是金賽藥業研發的一款人源化PD-1單抗,通過和PD-1結合並激活PD-1抑制性信號通路以及ADCC效應,從而抑制或殺傷致病性T細胞,發揮特異的靶向免疫抑制作用。GenSci120注射液在美國屬於351(a)類藥物,擬用於類風濕關節炎(RA)患者,其新藥臨牀試驗申請已達到FDA規定的默示許可期,該項目即可在美國開始進行臨牀試驗。金賽藥業將按照FDA相關要求,有序開展相關後續工作。
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.