发明公开
EP2916819A1 LIQUID FORMULATION OF PROTEIN CONJUGATE COMPRISING THE OXYNTOMODULIN AND AN IMMUNOGLOBULIN FRAGMENT
审中-公开
液体制剂与泌酸调节素蛋白偶联物和免疫球蛋白片段
- 专利标题: LIQUID FORMULATION OF PROTEIN CONJUGATE COMPRISING THE OXYNTOMODULIN AND AN IMMUNOGLOBULIN FRAGMENT
- 专利标题(中): 液体制剂与泌酸调节素蛋白偶联物和免疫球蛋白片段
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申请号: EP13853118.1申请日: 2013-11-06
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公开(公告)号: EP2916819A1公开(公告)日: 2015-09-16
- 发明人: KIM, Hyun Uk , LIM, Hyung Kyu , JANG, Myung Hyun , KIM, Sang Yun , BAE, Sung Min , KWON, Se Chang
- 申请人: Hanmi Pharm. Co., Ltd.
- 申请人地址: 214 Muha-ro Paltan-myeon Hwaseong-si, Gyeonggi-do 445-958 KR
- 专利权人: Hanmi Pharm. Co., Ltd.
- 当前专利权人: Hanmi Pharm. Co., Ltd.
- 当前专利权人地址: 214 Muha-ro Paltan-myeon Hwaseong-si, Gyeonggi-do 445-958 KR
- 代理机构: Schiweck, Weinzierl & Koch
- 优先权: KR20120124725 20121106
- 国际公布: WO2014073842 20140515
- 主分类号: A61K9/08
- IPC分类号: A61K9/08 ; A61K38/26 ; C07K14/605 ; A61K39/395
摘要:
The present invention relates to an albumin-free liquid formulation comprising a long-lasting oxyntomodulin conjugate in which an oxyntomodulin peptide comprising a derivative, variant, precursor or fragment of oxyntomodulin is linked to an immunoglobulin Fc region, which can increase the duration of physiological activity of the long-lasting oxyntomodulin conjugate and maintain the
invivo stability thereof for an extended period of time, as compared to native oxyntomodulin, as well as a method for preparing the liquid formulation. The liquid formulation comprises a buffer, a sugar alcohol and a nonionic surfactant and does not contain a human serum albumin and factors that are potentially harmful to the human body, and thus is not susceptible to viral infection. In addition, the oxyntomodulin conjugate of the invention comprises oxyntomodulin linked to an immunoglobulin Fc region, and thus has a large molecular weight, prolonged physiological activity, and excellent storage stability, compared to native oxyntomodulin.
invivo stability thereof for an extended period of time, as compared to native oxyntomodulin, as well as a method for preparing the liquid formulation. The liquid formulation comprises a buffer, a sugar alcohol and a nonionic surfactant and does not contain a human serum albumin and factors that are potentially harmful to the human body, and thus is not susceptible to viral infection. In addition, the oxyntomodulin conjugate of the invention comprises oxyntomodulin linked to an immunoglobulin Fc region, and thus has a large molecular weight, prolonged physiological activity, and excellent storage stability, compared to native oxyntomodulin.
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