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1. 发明申请

WO2014017845A2 A LIQUID FORMULATION OF LONG ACTING INSULINOTROPIC PEPTIDE CONJUGATE 审中-公开
标题翻译：长效胰岛素诱导剂的液体配方
公开(公告)号：WO2014017845A2
公开(公告)日：2014-01-30
申请号：PCT/KR2013006670
申请日：2013-07-25
申请人： HANMI PHARM IND 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
CPC分类号： A61K47/6811 , A61K9/08 , A61K38/26 , A61K47/02 , A61K47/26 , A61K47/48415 , A61K47/68
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区组成的长效促胰岛素肽缀合物; 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。为了防止微生物污染，可以加入防腐剂。本发明的液体制剂不含人体血清白蛋白和其他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. 发明公开

EP2877158A4 A LIQUID FORMULATION OF LONG ACTING INSULINOTROPIC PEPTIDE CONJUGATE 有权
标题翻译：具有长期效果的促胰岛素肽缀合物的液体制剂
公开(公告)号：EP2877158A4
公开(公告)日：2016-03-23
申请号：EP13823275
申请日：2013-07-25
申请人： HANMI PHARM IND 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
CPC分类号： A61K47/6811 , A61K9/08 , A61K38/26 , A61K47/02 , A61K47/26 , A61K47/48415 , A61K47/68
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.

3. 发明公开

EP3050559A4 SUSTAINED TYPE HUMAN GROWTH HORMONE PREPARATION 无效
标题翻译： MENSCHLICHESHORMONWACHSTUMSPRÄPARATMITVERZÖGERTERFREISETZUNG
公开(公告)号：EP3050559A4
公开(公告)日：2017-05-31
申请号：EP14847086
申请日：2014-09-26
申请人： HANMI PHARM IND CO LTD
发明人： RIM HWA PEOUNG , KIM HYUN UK , IM HO TAEK , KIM SANG YUN , LIM HYUNG KYU , BAE SUNG MIN , KWON SE CHANG
IPC分类号： A61K9/19 , A61K9/08 , A61K38/25 , A61K38/27 , A61K47/30 , A61K47/68
CPC分类号： A61K47/48415 , A61K9/0019 , A61K9/19 , A61K38/27 , A61K47/12 , A61K47/183 , A61K47/26 , A61K47/68 , A61K47/6811 , A61K47/6883
摘要： The present invention relates to a sustained type human growth hormone conjugate preparation comprising: a sustained type human growth hormone (hGH) conjugate resulting from conjugation between the immunoglobulin Fc region and a human growth hormone (hGH) constituting a bioactive peptide; a buffer solution; a nonionic surfactant; and a sugar alcohol. More specifically, the present invention relates to a sustained type human growth hormone conjugate freeze dried preparation and liquid preparation, to a production method for the freeze dried preparation, to a method of reconstituting the freeze dried preparation, and to a kit comprising the freeze dried preparation and a reconstituting solution.
摘要翻译：本发明涉及一种持续型人生长激素缀合物制剂，其包含：由免疫球蛋白Fc区和构成生物活性肽的人生长激素（hGH）之间的缀合产生的持续型人生长激素（hGH）缀合物; 一种缓冲溶液; 非离子表面活性剂; 和一种糖醇。更具体而言，本发明涉及一种持续型人生长激素缀合物冷冻干燥制剂和液体制剂，涉及该冻干制剂的生产方法，涉及一种重构该冻干制剂的方法，以及一种包含该冷冻干燥制剂的试剂盒准备和重构解决方案。

4. 发明公开

EP2963055A4 SITE-SPECIFIC INSULIN CONJUGATE 有权
标题翻译： ORTSSPEZIFISCHE INSULINKONJUGATE
公开(公告)号：EP2963055A4
公开(公告)日：2016-10-19
申请号：EP14757574
申请日：2014-02-26
申请人： HANMI PHARM IND CO LTD
发明人： JANG MYUNG HYUN , KIM DAE JIN , HWANG SANG YOUN , KIM HYUN UK , JUNG SUNG YOUB , KWON SE CHANG
IPC分类号： A61K47/48 , A61K38/28 , A61P3/10 , C07K14/62 , C07K17/08
CPC分类号： A61K47/48369 , A61K38/28 , A61K47/68 , A61K47/6811 , A61K47/6889 , C07K14/62 , C07K17/08 , C07K2319/30
摘要： Provided are an insulin conjugate having improved insulin receptor binding affinity and increased activity, in which a non-peptidyl polymer and an immunoglobulin Fc region are site-specifically linked to an amino acid residue of the insulin beta chain excluding the N-terminus thereof via a covalent bond, a long-acting formulation including the same, and a preparation method thereof. The insulin conjugate of the present invention is used to provide an insulin formulation which exhibits a remarkably increased in vivo activity of the peptide.

5. 发明公开

EP2877157A4 A LIQUID FORMULATION OF LONG-ACTING INSULIN CONJUGATE 有权
标题翻译：佛罗里达州VON LANGWIRKENDEM INSULINKONJUGAT
公开(公告)号：EP2877157A4
公开(公告)日：2016-06-01
申请号：EP13822348
申请日：2013-07-25
申请人： HANMI PHARM IND 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 , A61K47/10 , A61K47/12 , A61K47/26 , 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。

6. 发明公开

EP3098235A4 LONG-ACTING INSULIN AND USE THEREOF 无效
公开(公告)号：EP3098235A4
公开(公告)日：2017-10-18
申请号：EP15737856
申请日：2015-01-20
申请人： HANMI PHARM IND CO LTD
发明人： JUNG SUNG YOUB , HWANG SANG YOUN , OH EUH LIM , PARK SUNG HEE , KIM HYUN UK , LIM CHANG KI , KWON SE CHANG
IPC分类号： C07K14/62 , A61K38/00 , A61K38/28 , A61P3/10
CPC分类号： C07K14/62 , A61K38/00 , C07K2319/30

7. 发明公开

EP2877201A4 A LIQUID FORMULATION OF LONG-ACTING INSULIN AND INSULINOTROPIC PEPTIDE 有权
标题翻译：胰岛素和LANGZEITWIRKENDEM促胰岛素释放肽的液体制剂
公开(公告)号：EP2877201A4
公开(公告)日：2016-03-30
申请号：EP13822545
申请日：2013-07-25
申请人： HANMI PHARM IND 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 , A61K47/48415 , 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.

8. 发明公开

EP2963056A4 NOVEL INSULIN ANALOG AND USE THEREOF 有权
标题翻译： NEUARTIGE INSULINANALOGA UND VERWENDUNG DAVON
公开(公告)号：EP2963056A4
公开(公告)日：2017-06-07
申请号：EP14757629
申请日：2014-02-26
申请人： HANMI PHARM IND CO LTD
发明人： HWANG SANG YOUN , HUH YONG HO , KIM JIN YOUNG , HONG SUNG HEE , CHOI IN YOUNG , JUNG SUNG YOUB , KWON SE CHANG , KIM DAE JIN , KIM HYUN UK , JANG MYUNG HYUN , KIM SEUNG SU
IPC分类号： A61K47/68 , C07K14/62
CPC分类号： A61K47/48415 , A61K47/68 , A61K47/6811 , C07K14/62 , C07K2319/30
摘要： The present invention relates to an insulin analog that has a reduced insulin titer and a reduced insulin receptor binding affinity compared to the native form for the purpose of increasing the blood half-life of insulin, a conjugate prepared by linking the insulin analog and a carrier, a long-acting formulation including the conjugate, and a method for preparing the conjugate.
摘要翻译：本发明涉及胰岛素类似物，其与天然形式相比具有降低的胰岛素效价和降低的胰岛素受体结合亲和力，目的是增加胰岛素的血液半衰期，所述缀合物通过连接胰岛素类似物和载体，包含缀合物的长效制剂以及制备缀合物的方法。

9. 发明公开

EP3040419A4 METHOD FOR MASS PRODUCING HUMAN BLOOD COAGULATION FACTOR VII DERIVATIVE 有权
标题翻译： VERFAHREN ZUR MASSENHUZEN EINES DERIVATS DES MENSCHLICHEN BLUTGERINNUNGSFAKTORS VII
公开(公告)号：EP3040419A4
公开(公告)日：2017-03-15
申请号：EP14839952
申请日：2014-08-27
申请人： HANMI PHARM IND CO LTD
发明人： KANG HEE CHUL , KIM JIN YOUNG , LEE BYUNG SUN , KIM HYUN UK , CHOI IN YOUNG , KWON SE CHANG
IPC分类号： C12N15/12 , C07K14/745 , C12N9/06 , C12N9/64 , C12N15/85 , C12P21/02
CPC分类号： C12N9/6437 , C07K14/745 , C12N9/003 , C12N15/85 , C12P21/02 , C12Y105/01003 , C12Y304/21021
摘要： The present invention provides a method for mass production of human coagulation factor VII derivatives, containing: a) constructing an expression vector, containing i) a nucleotide sequence of a dihydrofolate reductase promoter devoid of at least one CCGCCC repeat sequence from the GC-rich region thereof and a nucleotide sequence encoding a dihydrofolate reductase (DHFR) operably linked thereto, and ii) a nucleotide sequence of a cytomegalovirus (CMV) early gene promoter and a nucleotide sequence encoding a human coagulation factor VII derivative operably linked thereto; b) transfecting an animal cell line with the expression vector of step a); c) culturing the transfected animal cell line of step b) in the presence of a dihydrofolate reductase inhibitor to select a cell line capable of expressing the human coagulation factor VII derivative with high efficiency; and d) culturing the animal cell line selected from step c) by adding at least one selected from the group consisting of sodium butyrate, vitamin K, and a culture medium supplement. Employing a vector containing a DHFR promoter devoid of GC-rich repeat sequences, the present invention can express human coagulation factor VII derivates with high efficiency on a large scale, and thus can be useful for the preparation of therapeutic agents for hemophilia.
摘要翻译：本发明提供了一种大量生产人凝血因子VII衍生物的方法，其包含：a）构建表达载体，其含有i）不富含GC富集区的至少一个CCGCCC重复序列的二氢叶酸还原酶启动子的核苷酸序列和编码与之有效连接的二氢叶酸还原酶（DHFR）的核苷酸序列，和ii）巨细胞病毒（CMV）早期基因启动子的核苷酸序列和编码与之有效连接的人凝血因子VII衍生物的核苷酸序列; b）用步骤a）的表达载体转染动物细胞系; c）在二氢叶酸还原酶抑制剂的存在下培养步骤b）的转染的动物细胞系，以高效率选择能够表达人凝血因子VII衍生物的细胞系; 和d）通过加入选自丁酸钠，维生素K和培养基补充剂中的至少一种来培养选自步骤c）的动物细胞系。使用含有不富含GC的重复序列的DHFR启动子的载体，本发明可以大规模高效地表达人凝血因子VII衍生物，因此可用于制备血友病治疗剂。

10. 发明公开

EP2916819A4 LIQUID FORMULATION OF PROTEIN CONJUGATE COMPRISING THE OXYNTOMODULIN AND AN IMMUNOGLOBULIN FRAGMENT 有权
标题翻译： FLINSIGE FORMULIERUNG EINES PROTEINKONJUSAT MIT OXYNTOMODULIN UND EINEM IMMUNGLOBULINFRAGMENT
公开(公告)号：EP2916819A4
公开(公告)日：2016-08-17
申请号：EP13853118
申请日：2013-11-06
申请人： HANMI PHARM IND 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 , A61K9/00 , A61K38/26 , A61K39/395 , A61K47/10 , A61K47/12 , A61K47/26 , A61K47/48 , C07K14/605
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 in vivo 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：公开了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，其可以增加长时间的生理活性持续时间与天然胃泌酸调节素相比，能够延长胃泌酸调节蛋白缀合物并保持其长时间的体内稳定性，以及制备液体制剂的方法。液体制剂含有缓冲液，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。胃泌酸调节蛋白结合物含有与免疫球蛋白Fc区连接的胃泌酸调节蛋白，因此与天然胃泌酸调节蛋白相比具有大的分子量，延长的生理活性和优异的储存稳定性。

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