公开(公告)号：EP2921503A1

公开(公告)日：2015-09-23

申请号：EP13855456.3

申请日：2013-11-07

申请人： Shanghai Serum Biotechnology Co., Ltd. ,  Institute of Biotechnology, Academy of Military Medical Sciences, Pla.

发明人： SUN, Zhiwei ,  WANG, Shuang ,  SUN, Jiuru ,  ZHANG, Chang ,  QIU, Weiyi ,  FAN, Tiejiong

IPC分类号： C07K16/28 ,  C07K19/00 ,  C12N15/13 ,  C12N15/63 ,  C12N1/15 ,  C12N1/21 ,  C12N5/10 ,  G01N33/53 ,  C07K1/22 ,  A61K39/395 ,  A61P35/00 ,  A61P29/00 ,  A61P37/02

CPC分类号： C07K16/2863 ,  A61K39/39558 ,  A61K47/6849 ,  A61K47/6851 ,  A61K2039/505 ,  C07K1/22 ,  C07K16/30 ,  C07K2317/21 ,  C07K2317/24 ,  C07K2317/31 ,  C07K2317/565 ,  C07K2317/622 ,  C07K2317/73 ,  C07K2317/76 ,  C07K2317/92 ,  C07K2319/55 ,  C12N15/1037

摘要： The present invention provides human anti-human epidermal growth factor receptor (EGFR) antibodies and their encoding genes and applications thereof. By gene engineering means and phage surface display technology, the present invention screens anti-human EGFR gene engineering single chain antibody from fully synthetic single chain human antibody library, and obtains the antibody variable gene sequence thereof, and based thereon, constructs intact human monoclonal antibody, to further obtain high-purity antibody protein. The binding affinity of the antibody of the present invention with human EGFR is no more than 1 nM, and the mutants affinity thereof is no more than 10 nM; and the identification of the immunity activity and bioactivity of antibodies protein IgG is completed, confirming that the antibody of the present invention has good bioactivity of inhibiting the tumor growth of EGFR expressing cell A431 tumor-bearing model mouse. The antibodies of the present invention provides specific antibody drugs for preventing and treating EGFR targeted tumor and other diseases such as inflammation and autoimmune diseases.

摘要翻译： 本发明提供了人抗 - 人表皮生长因子受体（EGFR）抗体及其编码基因和它们的应用程序。 通过基因工程手段与噬菌体表面展示技术，本发明的屏幕的抗人EGFR基因工程从完全合成的单链人抗体文库的单链抗体，并且获得其抗体可变基因序列，并且基于此，构建完整的人单克隆抗体 ，つweiterer获得高纯度的抗体蛋白。 与人类EGFR本发明的抗体的结合亲和力是不大于1nM的更多，并且它们的突变体的亲和力是不超过10纳米; 和免疫活性和抗体的IgG蛋白的生物活性的鉴定完毕，确认做了本发明的抗体具有EGFR表达细胞A431荷瘤小鼠模型中的肿瘤生长的良好的生物活性抑制。 本发明的抗体提供特定抗体的药物用于预防和治疗EGFR靶向的肿瘤和其他疾病：如炎症和自身免疫性疾病。