公开(公告)号：US20240245609A1

公开(公告)日：2024-07-25

申请号：US18576866

申请日：2021-07-20

申请人： NOVOCODEX BIOPHARMACEUTICALS CO., LTD.

发明人： Lihai XIAO ,  Jiali CHEN ,  Moutian YE ,  Gang XIA ,  Jingjing ZHU ,  Lei FANG ,  Yuebin YING ,  Luxiong YE ,  Xuejun LIANG

IPC分类号： A61K9/19 ,  A61K47/18 ,  A61K47/26 ,  A61K47/68

CPC分类号： A61K9/19 ,  A61K47/183 ,  A61K47/26 ,  A61K47/68031 ,  A61K47/6855

摘要： The present invention provides a freeze-dried composition containing anti-HER2 drug conjugate, which comprises ARX788 and one or more of pharmaceutically acceptable lyoprotectant, buffer salts and surfactants, wherein the pH value of the freeze-dried composition is from 5.7 to 6.3. The present invention also provides a freeze-dried preparation containing anti-HER2 drug conjugate and the preparation method thereof. The present invention also provides use of the freeze-dried composition and the freeze-dried preparation. The freeze-dried composition and the freeze-dried preparation provided by the present invention have a very excellent stability, as well as good appearance, short reconstitution time and low moisture content. The product quality is safe and reliable, and the production efficiency is high. The preparation methods of the freeze-dried composition and the freeze-dried preparation provided by the present invention are simple and have low-cost, and they can be used for treating various cancers, and have broad application prospects.