You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
中國生物製藥(01177.HK)"TQB6411(EGFR/c-Met雙抗ADC)"臨牀試驗申請獲CDE受理
格隆匯 04-03 22:54

格隆匯4月3日丨中國生物製藥(01177.HK)公吿,集團自主研發的"TQB6411(EGFR/c-Met雙抗ADC)"已向中國國家藥品監督管理局藥品評審中心("CDE")提交臨牀試驗申請,並獲得受理。

表皮生長因子受體(EGFR)和細胞間質上皮轉換因子(c-Met)是兩種重要的肺癌驅動基因,都屬於受體酪氨酸激酶,在下游信號轉導方面具有協同作用。聯合靶向EGFR和c-Met可以同時阻斷PI3K/AKT/mTOR與Ras/Raf/Mek雙通路,通過抑制代償性激活,增強抗腫瘤效應。

TQB6411是一種靶向EGFR、c-Met的抗體偶聯藥物(ADC),靜脈注入血後抗體部分與腫瘤細胞表面EGFR、c-Met結合阻斷EGFR、c-Met信號通路,ADC經細胞內吞併轉運到溶酶體,連接子經酶切後釋放出DDDXD,導致DNA損傷和細胞死亡。體外研究顯示,TQB6411具有抗體依賴細胞介導的細胞毒性作用(ADCC),並且DDDXD能通過旁殺效應殺死相鄰腫瘤細胞。

TQB6411已完成系統的藥理學、藥代動力學和安全性驗證,具有明確的抗腫瘤作用機制,對EGFR及c-Met不同表達和耐藥的陽性細胞均有明顯的抑瘤作用,體外活性與同靶點藥物AZD9592相當,體內活性明顯優於AZD9592。

除TQB6411外,集團在EGFR和c-Met靶點領域,還佈局有TQB2922(EGFR/c-Met雙抗)並已於2023年12月啟動I期臨牀,TQB3002(四代EGFR抑制劑)位於I期臨牀並已於美國獲批臨牀試驗,以及FHND9041(三代EGFR抑制劑)位於III期臨牀。集團將加速推進該等產品的臨牀開發進程,聚焦全球尚未被滿足的臨牀需求,為患者提供更優的治療選擇。

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.
uSMART
Wealth Growth Made Easy
Open Account