Title:
FREEZE-DRIED COMPOSITION CONTAINING ANTI-HER2 DRUG CONJUGATE, FREEZE-DRIED PREPARATION AND PREPARATION METHOD THEREFOR AND USE THEREOF
Document Type and Number:
WIPO Patent Application WO/2023/000171
Kind Code:
A1
Abstract:
Provided in the present invention is a freeze-dried composition containing an anti-HER2 drug conjugate, which comprises ARX788 and one or more of a pharmaceutically acceptable freeze-dried protective agent, a buffer salt and a surfactant, wherein the pH value of the freeze-dried composition is 5.7-6.3. Further provided in the present invention are a freeze-dried preparation containing the anti-HER2 drug conjugate and a preparation method therefor. Also provided in the present invention is the use of the freeze-dried composition and the freeze-dried preparation. The freeze-dried composition and freeze-dried preparation provided in the present invention have a good stability, good appearance, short redissolving time, low water content, safe and reliable product quality and high production efficiency. The freeze-dried composition and freeze-dried preparation provided in the present invention have a simple and convenient preparation method and low cost, can be used for treating various cancers, and have broad application prospects.
Inventors:
XIAO LIHAI (CN)
CHEN JIALI (CN)
YE MOUTIAN (CN)
XIA GANG (CN)
ZHU JINGJING (CN)
FANG LEI (CN)
YING YUEBIN (CN)
LIANG XUEJUN (CN)
CHEN JIALI (CN)
YE MOUTIAN (CN)
XIA GANG (CN)
ZHU JINGJING (CN)
FANG LEI (CN)
YING YUEBIN (CN)
LIANG XUEJUN (CN)
Application Number:
PCT/CN2021/107402
Publication Date:
January 26, 2023
Filing Date:
July 20, 2021
Export Citation:
Assignee:
NOVOCODEX BIOPHARMACEUTICALS CO LTD (CN)
International Classes:
A61K9/19; A61K47/18; A61K47/26; A61K47/68
Domestic Patent References:
| WO2020192693A1 | 2020-10-01 |
Foreign References:
| CN104619351A | 2015-05-13 | |||
| CN103717595A | 2014-04-09 | |||
| CN111939267A | 2020-11-17 |
Other References:
LILLIAN, S. ET AL.: "ARX788, a Site-specific Anti-HER2 Antibody-Drug Conjugate, Demonstrates Potent and Selective Activity in HER2-low and T-DM1-resistant Breast and Gastric Cancers", MOLECULAR CANCER THERAPEUTICS, vol. 19, no. 9, 30 September 2020 (2020-09-30), XP055933201, DOI: 10.1158/1535-7163.MCT-19-1004
Attorney, Agent or Firm:
SINO-CREATIVITY INTELLECTUAL PROPERTY LAW FIRM (CN)
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