復宏漢霖(02696.HK):重組抗CD73全人源單克隆抗體注射液HLX23臨試申請獲FDA批准
格隆匯5月31日丨復宏漢霖(02696.HK)發佈公吿,近日,公司控股子公司Hengenix Biotech,Inc.收到美國食品藥品管理局(FDA)關於同意重組抗CD73全人源單克隆抗體注射液HLX23用於晚期實體瘤治療進行臨牀試驗的函。
根據披露,HLX23是該公司自主研發的抗CD73(胞外-5’-核苷酸酶,Ecto-5’-Nucleotidase)創新型全人源IgG2單克隆抗體,擬用於晚期實體瘤治療(包括黑色素瘤、非小細胞肺癌、肝細胞癌等)。HLX23的作用機制是通過其Fab域與癌細胞和免疫細胞表面的CD73特異性結合,抑制CD73核苷酸酶活性並促進CD73內吞。臨牀前藥理學研究、藥代動力學研究及安全性評價證明,HLX23可體外抑制CD73酶活性和促進CD73內吞,體內可抑制腫瘤生長,且具有良好的耐受性及安全性。截至該公吿日,於全球範圍內尚無靶向CD73的單克隆抗體藥品上市。
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.