中国生物制药(01177):1类创新药注射用TQB6411 (EGFR/c-MET双抗ADC)完成首例受试者给药

智通财经
Jul 22, 2025

智通财经APP讯,中国生物制药(01177)发布公告,本集团自主开发的1类创新药注射用TQB6411(EGFR/c-Met双抗ADC)近日在中国完成Ⅰ期临床研究的首例受试者入组并顺利给药。TQB6411于6月13日获得中国国家药品监督管理局(NMPA)批准开展临床试验,拟用于治疗晚期恶性肿瘤。目前研发进度处于全球第一梯队,全球同类药物均处于I期阶段。

TQB6411是一款靶向EGFR/c-Met的双抗ADC药物。EGFR和c-MET在非小细胞肺癌、结肠癌、头颈鳞癌、鼻咽癌等多种肿瘤中存在突变或异常高表达[1,2],因此,EGFR/c-MET双抗ADC的应用场景非常广泛。

TQB6411已完成系统的药理学、药代动力学和临床前安全性验证。临床前体内药效学研究显示, TQB6411具有明确的抗肿瘤作用机制,对EGFR、c-Met不同表达和耐药的动物模型均体现出抗肿瘤活性。TQB6411符合ADC药物的药代动力学特性,主要毒性反应为靶点的药理学作用和小分子毒素所致,毒性风险可控。目前开展的I期临床试验将重点评估其在人体内的安全性、耐受性、药代动力学特性及初步疗效。

除TQB6411外,本集团还有TQB2102(HER2双抗ADC)位于临床III期、LM-302(CLDN18.2 ADC)位于临床III期,LM-305(GPRC5D ADC)位于临床I/II期,TQB2101 (ROR1 ADC)位于临床I期,以及数十款ADC项目位于临床前开发中,预计将在未来1-2年陆续进入临床阶段。

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10