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Title:
PREPARATION METHOD FOR CONCENTRATED SOLUTION CONTAINING ANTI-HUMAN THYMIC STROMAL LYMPHOPOIETIN (TSLP) MONOCLONAL ANTIBODY, AND LIQUID PREPARATION
Document Type and Number:
WIPO Patent Application WO/2023/070948
Kind Code:
A1
Abstract:
The present application discloses a liquid preparation of an anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody, comprising the anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody and an amino acid protective agent, a protein concentration of the anti-human thymic stromal lymphopoietin (TSLP) monoclonal antibody being 100-300 mg/ml, and an amino acid concentration of the amino acid protective agent being 10-500 mM. The monoclonal antibody comprises three heavy chain complementarity determining regions (CDR-H1, CDR-H2, and CDR-H3) and three light chain complementarity determining regions (CDR-L1, CDR-L2, and CDR-L3), an amino acid sequence of the CDR-H1 being as shown in SEQ ID NO:1; an amino acid sequence of the CDR-H2 being as shown in SEQ ID NO:2; an amino acid sequence of the CDR-H3 being as shown in SEQ ID NO:3; an amino acid sequence of the CDR-L1 amino acid sequence being as shown in SEQ ID NO:4; an amino acid sequence of the CDR-L2 being as shown in SEQ ID NO:5; and an amino acid sequence of the CDR-L3 being as shown in SEQ ID NO:6. The liquid preparation of the present application has a low viscosity and can be easily pushed by an injector, so that the liquid preparation can be used as an injection, particularly a subcutaneous injection.

Inventors:
XUE GANG (CN)
ZHU HUAJIE (CN)
DAI CHANGSONG (CN)
LI SHUAI (CN)
XU QIN (CN)
GUO CAIMING (CN)
CHEN WEI (CN)
WU YILIANG (CN)
Application Number:
PCT/CN2022/071381
Publication Date:
May 04, 2023
Filing Date:
January 11, 2022
Export Citation:
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Assignee:
QYUNS THERAPEUTICS CO LTD (CN)
International Classes:
A61K39/395; A61K9/08; A61K47/18; A61K47/22; A61P11/06; A61P37/02; C07K1/18; C07K1/22; C07K1/34; C07K1/36; C07K16/24
Foreign References:
CN113501878A2021-10-15
US20120190829A12012-07-26
EP2628752A12013-08-21
US20200325218A12020-10-15
Other References:
NAKAJIMA SAEKO, KABATA HIROKI, KABASHIMA KENJI, ASANO KOICHIRO: "Anti-TSLP antibodies: Targeting a master regulator of type 2 immune responses", ALLERGOLOGY INTERNATIONAL, vol. 69, no. 2, 1 April 2020 (2020-04-01), JP , pages 197 - 203, XP055945966, ISSN: 1323-8930, DOI: 10.1016/j.alit.2020.01.001
Attorney, Agent or Firm:
BEIJING TANGSONG IP FIRM (CN)
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