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An anti-human PD-1 monoclonal antibody preparation, combined drug and use thereof

A monoclonal antibody, PD-1 technology, applied in the direction of antibody, drug combination, drug delivery, etc., can solve problems such as difficult to apply PD-1 antibody, differences in physical and chemical properties and advanced conformation, and different amino acid sequence composition

Active Publication Date: 2022-06-17
SHANGHAI QILU PHARM RES & DEV CENT LTD
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  • Claims
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AI Technical Summary

Problems solved by technology

The main dosage form of antibody drugs is injection. Patent applications such as CN103429264A, CN106390115A and CN107334728A all disclose the preparation of PD-1 antibodies. However, the amino acid sequence composition of different PD-1 antibodies is different, resulting in differences in their physical and chemical properties and advanced conformations. Therefore, it is difficult to apply the composition of the existing dosage forms in the prior art to all PD-1 antibodies

Method used

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  • An anti-human PD-1 monoclonal antibody preparation, combined drug and use thereof
  • An anti-human PD-1 monoclonal antibody preparation, combined drug and use thereof
  • An anti-human PD-1 monoclonal antibody preparation, combined drug and use thereof

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Embodiment Construction

[0007] The purpose of the present invention is to provide a stable solution preparation suitable for the monoclonal antibody ZMR01 and its use.

[0008] The stable solution formulation of the present invention contains the monoclonal antibody ZMR01 or an antigen-binding fragment thereof and a buffer. The solution formulations may also contain stabilizers and / or surfactants.

[0009] In the solution preparation of the present invention, the HCDR sequences of the antibody heavy chain variable region of the monoclonal antibody ZMR01 or its antigen-binding fragment are as follows: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3; And, the antibody light chain variable region LCDR sequence is: SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6. The amino acid sequence is shown in the following table:

[0010]

[0011] A further preferred monoclonal antibody ZMR01 has the heavy chain variable region of SEQ ID NO:7 and the amino acid sequence of the light chain variable region of SEQ ID NO:8:

[00...

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Abstract

The present invention relates to a pharmaceutical preparation of a stable anti-human PD‑1 antibody, a combined drug and its application. The pharmaceutical preparation contains an anti-human PD‑1 monoclonal antibody, a stabilizer, a buffer and a surfactant. The pharmaceutical preparation of the anti-human PD‑1 antibody of the present invention can effectively inhibit the aggregation and deamidation of the antibody, thereby preventing the degradation of the antibody protein and obtaining a stable pharmaceutical preparation. The combined drug of the present invention is the combined use of the pharmaceutical preparation of the anti-human PD-1 antibody and other additional therapeutic agents, and the use of the pharmaceutical preparation or the combined drug in the preparation of anti-tumor drugs.

Description

technical field [0001] The invention relates to a stable anti-human PD-1 monoclonal antibody pharmaceutical preparation, a combination drug and its use, belonging to the field of biotechnology. Background technique [0002] There is an extremely complex relationship between the immune escape mechanism of tumors and the body's immune response to tumors. In the early stage of tumor immunotherapy, tumor-specific killer T cells are biologically active, but with the continuous growth of tumors, they lose their killing function in the later stage. Therefore, tumor immunotherapy is to maximize the patient's own immune system response to the tumor. It not only activates the original immune system response in the body, but also maintains the duration and intensity of the immune system response. key to tumors. [0003] Programmed death-1 (PD-1) is a protein receptor that was discovered in 1992 and expressed on the surface of T cells and is involved in the process of cell apoptosis. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61K9/08A61K47/26A61P35/00
CPCC07K16/2818A61K9/08A61K47/26A61P35/00A61K2039/505A61K39/395
Inventor 周兵兵孙丽霞张乐王克波李敏昱王庆民吴晓冉曹传增郑庆梅赵春媛赵洪令张美娟
Owner SHANGHAI QILU PHARM RES & DEV CENT LTD
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