FIELD: pharmaceutics.
SUBSTANCE: group of inventions relates to the field of pharmaceuticals and medicine. The inventions are a pharmaceutical composition for the treatment of a tumor containing from 0.5 mg/ml to 100 mg/ml of the fused protein of the transforming growth factor beta receptor (TGF-β), from 5 mM to 30 mM citrate buffer, from 50 mg/ml to 100 mg/ml sucrose or trehalose and from 0.1 mg/ml to 0.8 mg/ml of polysorbate 80; where the fused protein of the TGF-β receptor contains a fused peptide formed by the heavy chain of the anti-PD-L1 antibody and the extracellular domain (ECD) TGF-βRII, with the sequence SEQ ID NO: 23, and the light chain of the anti-PD-L1 antibody with the sequence SEQ ID NO: 13, and the structure of the fused protein of the TGF-β receptor is shown in dwg. 1; the pH of the pharmaceutical composition is from 6.0 to 6.5; and the method for its preparation. The inventions also represent a lyophilized preparation for the treatment of a tumor, which is obtained by lyophilization of a pharmaceutical composition; a reconstituted solution, which is obtained by restoring a lyophilized drug; a product for the treatment of a tumor and the use of a pharmaceutical composition to obtain a drug.
EFFECT: physical and chemical stability of the composition for the treatment of a tumor.
23 cl, 8 dwg, 18 tbl, 21 ex
