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1. 发明申请

WO2014017845A3 A LIQUID FORMULATION OF LONG ACTING INSULINOTROPIC PEPTIDE CONJUGATE 审中-公开
标题翻译：长效胰岛素肽共轭物的液体制剂
公开(公告)号：WO2014017845A3
公开(公告)日：2014-01-30
申请号：PCT/KR2013/006670
申请日：2013-07-25
申请人： HANMI PHARM. CO., LTD.
发明人： KIM, Hyun Uk , LIM, Hyung Kyu , HONG, Sung Hee , KIM, Dae Jin , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K9/08 , A61K38/26 , A61K38/28 , A61K47/48
摘要： The present invention relates to a liquid formulation of long-acting insulinotropic peptide conjugate, comprising a pharmaceutically effective amount of long-acting insulinotropic peptide conjugate consisting of a physiologically active peptide, insulinotropic peptide, and an immunoglobulin Fc region; and an albumin-free stabilizer, wherein the stabilizer comprises a buffer, a sugar alcohol, a non-ionic surfactant, and an isotonic agent, and a method for preparing the formulation. For the purpose of preventing microbial contamination, a preservative may be added. The liquid formulation of the present invention is free of human serum albumin and other potentially hazardous factors to body, having no risk of viral contamination, and thus can provide excellent storage stability for insulinotropic peptide conjugates at high concentration.
摘要翻译：本发明涉及长效促胰岛素肽缀合物的液体制剂，其包含药学有效量的由生理活性肽，促胰岛素肽和免疫球蛋白Fc组成的长效促胰岛素肽缀合物地区; 和不含白蛋白的稳定剂，其中稳定剂包含缓冲剂，糖醇，非离子表面活性剂和等渗剂，以及制备该制剂的方法。为了防止微生物污染，可以加入防腐剂。本发明的液体制剂不含人血清白蛋白和其它对身体有潜在危害的因素，没有病毒污染的风险，因此可以为高浓度的促胰岛素肽缀合物提供优异的储存稳定性。

2. 发明申请

WO2014073842A1 LIQUID FORMULATION OF PROTEIN CONJUGATE COMPRISING THE OXYNTOMODULIN AND AN IMMUNOGLOBULIN FRAGMENT 审中-公开
标题翻译：含有蛋白质结合蛋白质和免疫球蛋白片段的液体配方
公开(公告)号：WO2014073842A1
公开(公告)日：2014-05-15
申请号：PCT/KR2013/009986
申请日：2013-11-06
申请人： HANMI PHARM. CO., LTD.
发明人： KIM, Hyun Uk , LIM, Hyung Kyu , JANG, Myung Hyun , KIM, Sang Yun , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K9/08 , A61K38/26 , C07K14/605 , A61K39/395
CPC分类号： A61K47/26 , A61K9/0019 , A61K9/08 , A61K38/22 , A61K38/26 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/20 , A61K47/22 , A61K47/68 , A61K47/6811 , A61K47/6851 , C07K14/605 , C07K2319/30
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.
摘要翻译：本发明涉及一种不含白蛋白的液体制剂，其包含持久性胃泌酸调节蛋白缀合物，其中包含胃泌酸调节蛋白的衍生物，变体，前体或片段的胃泌酸调节肽与免疫球蛋白Fc区连接，其可以增加生理活性的持续时间的长效胃泌酸调节蛋白缀合物，并且与天然胃泌酸调节素相比保持其延长的时间段的体内稳定性，以及制备液体制剂的方法。液体制剂包含缓冲液，糖醇和非离子表面活性剂，并且不含人血清白蛋白和对人体有潜在危害的因子，因此不易受病毒感染。此外，与天然胃泌酸调节素相比，本发明的胃泌酸调节蛋白结合物包含与免疫球蛋白Fc区连接的胃泌酸调节蛋白，因此具有大分子量，延长的生理活性和优异的储存稳定性。

3. 发明申请

WO2014017849A1 A LIQUID FORMULATION OF LONG-ACTING INSULIN AND INSULINOTROPIC PEPTIDE 审中-公开
标题翻译：长效胰岛素和胰岛素肽的液体制剂
公开(公告)号：WO2014017849A1
公开(公告)日：2014-01-30
申请号：PCT/KR2013/006676
申请日：2013-07-25
申请人： HANMI PHARM. CO., LTD.
发明人： LIM, Hyung Kyu , KIM, Hyun Uk , LEE, Mi Kyoung , LEE, Jong Soo , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K38/28 , A61K9/08 , A61K38/18
CPC分类号： A61K47/6811 , A61K38/22 , A61K38/26 , A61K38/28 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/22 , A61K47/68 , A61K2300/00
摘要： The present invention relates to a liquid formulation of a combination of long-acting insulin and insulinotropic peptide, comprising insulin which is a physiologically active peptide, insulinotropic peptide, and albumin-free stabilizer, wherein the stabilizer comprises a buffer, a sugar alcohol, a non-ionic surfactant, and an isotonic agent; and a method for preparing the liquid formulation. The liquid formulation of the present invention does not contain a human serum albumin and potentially toxic factors to the body, and thus it has excellent storage stability for insulin conjugate and insulinotropic peptide conjugate at high concentration, without a risk of viral contamination.
摘要翻译：本发明涉及长效胰岛素和促胰岛素肽的组合的液体制剂，其包含生理活性肽，促胰岛素肽和无白蛋白的稳定剂的胰岛素，其中稳定剂包括缓冲液，糖醇，非离子表面活性剂和等渗剂; 以及制备液体制剂的方法。本发明的液体制剂不含有人血清白蛋白和潜在的毒性因素，因此对于高浓度的胰岛素缀合物和促胰岛素肽缀合物具有优异的储存稳定性，没有病毒污染的风险。

4. 发明申请

WO2017052329A1 PROTEIN COMPLEX BY USE OF A SPECIFIC SITE OF AN IMMUNOGLOBULIN FRAGMENT FOR LINKAGE 审中-公开
标题翻译：蛋白复合物通过使用免疫球蛋白片段的特定位点进行连接
公开(公告)号：WO2017052329A1
公开(公告)日：2017-03-30
申请号：PCT/KR2016/010762
申请日：2016-09-26
申请人： HANMI PHARM. CO., LTD.
发明人： KIM, Dae Jin , LEE, Jong Soo , PARK, Young Jin , HONG, Sung Hee , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K47/48 , C07K1/18 , C07K1/22 , C07K1/36 , B01D15/30 , B01D15/32 , B01D15/36 , B01D15/34
CPC分类号： A61K47/68 , B01D15/327 , B01D15/34 , B01D15/362 , B01D15/363 , B01D15/3804
摘要： Provided is a complex composition, of which positional isomers are minimized by using a N-terminus of an immunoglobulin Fc region as a binding site when the immunoglobulin Fc region is used as a carrier. Also provided are a protein complex which is prepared by N-terminal-specific binding of immunoglobulin Fc region, thereby prolonging blood half-life of the physiologically active polypeptide, maintaining in vivo potency at a high level, and having no risk of immune responses, a preparation method thereof, and a pharmaceutical composition including the same for improving in vivo duration and stability of the physiologically active polypeptide. The protein complex prepared by the present invention may be usefully applied to the development of long-acting formulations of various physiologically active polypeptide drugs.
摘要翻译：提供了当使用免疫球蛋白Fc区作为载体时，通过使用免疫球蛋白Fc区的N末端作为结合位点使位置异构体最小化的复合组合物。还提供了通过免疫球蛋白Fc区的N末端特异性结合制备的蛋白质复合物，从而延长生理活性多肽的血液半衰期，维持体内效力在高水平，并且没有免疫应答的风险，其制备方法和包含其的用于改善生理活性多肽的体内持续时间和稳定性的药物组合物。通过本发明制备的蛋白质复合物可有效地应用于各种生理活性多肽药物的长效制剂的开发。

5. 发明申请

WO2014017847A1 A LIQUID FORMULATION OF LONG-ACTING INSULIN CONJUGATE 审中-公开
标题翻译：长寿命胰岛素联合液的液体配方
公开(公告)号：WO2014017847A1
公开(公告)日：2014-01-30
申请号：PCT/KR2013/006673
申请日：2013-07-25
申请人： HANMI PHARM. CO., LTD.
发明人： LIM, Hyung Kyu , KIM, Hyun Uk , HONG, Sung Hee , KIM, Min Young , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K9/08 , A61K38/26 , A61K38/28 , A61K47/48
CPC分类号： A61K47/26 , A61K38/28 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/68
摘要： The present invention relates to a liquid formulation of long-acting insulin conjugate, comprising a pharmaceutically effective amount of a long-acting insulin conjugate, wherein a physiologically active peptide, which is an insulin, is linked to an immunoglobulin Fc region; and an albumin-free stabilizer, wherein the stabilizer comprises a buffer, a sugar alcohol, a non-ionic surfactant, and an isotonic agent, and a method for preparing the formulation. For preventing microbial contamination in multiple uses, a preservative can be added to the formulation. The liquid formulation of the present invention does not comprise a human serum albumin and potentially hazardous factors to body, and thus it has excellent storage stability for insulin conjugate without a risk of viral infection.
摘要翻译：本发明涉及长效胰岛素缀合物的液体制剂，其包含药学有效量的长效胰岛素缀合物，其中作为胰岛素的生理活性肽与免疫球蛋白Fc区连接; 和无白蛋白的稳定剂，其中稳定剂包括缓冲液，糖醇，非离子表面活性剂和等渗剂，以及制备该制剂的方法。为了防止多种用途中的微生物污染，可以向制剂中加入防腐剂。本发明的液体制剂不包含人血清白蛋白和对身体的潜在危险因素，因此对于没有病毒感染风险的胰岛素缀合物具有优异的储存稳定性。

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