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AssigneeNovocodex Biopharmaceuticals Co., Ltd.
InventorsLihai Xiao, Jiali Chen, Moutian Ye, Gang Xia, Jingjing Zhu, Lei Fang, Yuebin Ying, Luxiong Ye, Xuejun Liang
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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.
A freeze-dried composition containing anti-HER2 drug conjugate, wherein the freeze-dried composition comprises 10 mg/mL to 30 mg/mL of ARX788, 5 mM to 10 mM of histidine, 2.5 wt. % to 8 wt. % trehalose and 0.01 wt. % to 0.05 wt. % of polysorbate 80, wherein the pH value of the freeze-dried composition is from 6.0 to 6.3.
Dependencies are inferred from the claim text.