復宏漢霖(02696.HK):HLX35用於治療晚期惡性實體瘤的臨牀試驗申請獲國藥監局批准
格隆匯1月4日丨復宏漢霖(02696.HK)宣佈,近日,公司自主研發的HLX35(重組人源抗EGFR和抗4-1BB雙特異性抗體注射液)("HLX35")用於治療晚期惡性實體瘤的臨牀試驗申請(IND)獲國家藥品監督管理局("NMPA")批准。公司擬於近期條件具備後於中國境內(不包括港澳台地區)開展1期臨牀試驗。
HLX35是公司自主研發的創新型抗EGFR(表皮細胞生長因子受體)和抗4-1BB(即CD137,屬腫瘤壞死因子受體家族的成員)雙靶點的雙特異性抗體,擬用於治療晚期惡性實體瘤。根據臨牀前研究結果,HLX35顯示出比抗4-1BB或抗EGFR單克隆抗體的單一或聯合治療都更加優越的腫瘤抑制效果。雙特異性抗體藥物可有效將兩個靶點的優勢合併在一起,HLX35可以結合在腫瘤表面的EGFR分子上,阻斷EGFR的激活和下游信號通路的磷酸化,殺死腫瘤細胞;同時還可以在EGFR的參與下,結合免疫細胞(T細胞和NK細胞)表面上的4-1BB免疫激活分子,使更多的免疫細胞聚集在腫瘤周圍,並刺激微環境中免疫細胞的活性,從而協同殺死腫瘤細胞,提高療效。
2020年11月,公司就HLX35向Binacea pharma Inc.授出一項獨家許可,供其於除中國(包括港澳台地區)以外的全球範圍進行研究、開發、生產和商業化HLX35。
截至公吿日,於全球範圍內尚無靶向EGFR和4-1BB的雙特異性抗體上市。
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.