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21. 发明申请

WO2013051900A2 BLOOD COAGULATION FACTOR Ⅶ AND ⅦA DERIVATIVES, CONJUGATES AND COMPLEXES COMPRISING THE SAME, AND USE THEREOF 审中-公开
标题翻译：血液凝血因子Ⅶ和Ⅶ衍生物，结合物和包含其的复合物及其用途
公开(公告)号：WO2013051900A2
公开(公告)日：2013-04-11
申请号：PCT/KR2012/008102
申请日：2012-10-05
申请人： HANMI SCIENCE CO., LTD.
发明人： KIM, Dae Jin , LEE, Byung Sun , HONG, Sung Hwan , HUH, Yong Ho , JUNG, Sung Youb , KWON, Se Chang
IPC分类号： A61K38/36 , A61K38/16 , A61K48/00 , A61P7/04
CPC分类号： A61K38/4846 , A61K47/6815 , A61K48/00 , C07K2319/30 , C07K2319/31 , C07K2319/50 , C12N9/6437
摘要： The present invention relates to a blood coagulation factor Ⅶ derivative, a blood coagulation factor Ⅶa derivative, FacⅦ and FacⅦa conjugates each prepared by linking a polymer capable of extending the blood half-life to the derivative, FacⅦ and Ⅶa complexes each prepared by linking a carrier to the conjugate, genes encoding the FacⅦ and FacⅦa derivatives, expression vectors comprising the genes, transformants introduced with the expression vectors, a method for preparing the FacⅦ and FacⅦa derivatives using the transformants, a method for preparing the FacⅦa conjugate and complex, a FacⅦa complex prepared by the method, a pharmaceutical composition for the prevention or treatment of hemophilia comprising the derivative, conjugate, or complex as an active ingredient, and a pharmaceutical composition for blood coagulation comprising the derivative, conjugate, or complex as an active ingredient. Further, the present invention relates to a method for preventing or treating hemophilia or for promoting blood coagulation, comprising administering to a subject a therapeutically effective amount of the composition. The FacⅦ or FacⅦa derivative of the present invention is able to bind with a carrier capable of improving the blood half-life while maintaining the activity of FacⅦ or FacⅦa, and they can be widely used in the development of effective prophylactic or therapeutic agent for hemophilia.
摘要翻译：本发明涉及通过将能够延长血液半衰期的聚合物与衍生物FacⅦ和Ⅶa配合物制备的凝血因子Ⅶa衍生物，凝血因子Ⅶa衍生物，FacⅦ和FacⅦa缀合物，每种制剂通过连接一个载体结合物，编码FacⅦ和FacⅦa衍生物的基因，包含该基因的表达载体，用表达载体引入的转化体，使用转化体制备FacⅦ和FacⅦa衍生物的方法，制备FacⅦa缀合物和复合物的方法，通过该方法制备的FacⅦa复合物，用于预防或治疗包含衍生物，缀合物或复合物作为活性成分的血友病的药物组合物和包含衍生物，缀合物或复合物作为活性成分的用于凝血的药物组合物。此外，本发明涉及一种预防或治疗血友病或促进血液凝固的方法，包括向受试者施用治疗有效量的组合物。本发明的方案VII或FacⅦa衍生物能够与能够改善血液半衰期的载体结合，同时保持Fac VII或FacⅦa的活性，并且它们可广泛用于开发有效的血友病预防或治疗剂。

22. 发明申请

WO2013147559A1 A LIQUID FORMULATION OF HIGHLY CONCENTRATED LONG-ACTING HUMAN GROWTH HORMONE CONJUGATE 审中-公开
标题翻译：高浓度长效人体生长激素联合液的液体配方
公开(公告)号：WO2013147559A1
公开(公告)日：2013-10-03
申请号：PCT/KR2013/002660
申请日：2013-03-29
申请人： HANMI SCIENCE CO., LTD.
发明人： LIM, Hyung Kyu , KIM, Hyun Uk , HONG, Sung Hee , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K38/22 , A61K38/27 , A61K38/18 , A61K9/08
CPC分类号： A61K47/48369 , A61K9/0019 , A61K9/08 , A61K38/27 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/26 , A61K47/68 , A61K47/6811 , C07K14/61 , C07K2319/30
摘要： The present invention relates to a liquid formulation of highly concentrated long-acting human growth hormone conjugate, comprising a pharmaceutically effective amount of the long-acting human growth hormone conjugate in which human growth hormone (hGH) is linked to an immunoglobulin Fc region, and an albumin-free stabilizer, said stabilizer comprising a buffer, a non-ionic surfactant, a sugar alcohol, and sodium chloride as an isotonic agent, and a method for preparing the same.
摘要翻译：本发明涉及高浓度长效人生长激素结合物的液体制剂，其包含药学有效量的人类生长激素（hGH）与免疫球蛋白Fc区连接的长效人生长激素缀合物，以及不含白蛋白的稳定剂，所述稳定剂包含缓冲液，非离子表面活性剂，糖醇和作为等渗剂的氯化钠，及其制备方法。

23. 发明申请

WO2013137622A1 METHOD OF CULTURING E. COLI CELLS FOR HIGH DENSITY 审中-公开
标题翻译：培养高密度脂蛋白细胞的方法
公开(公告)号：WO2013137622A1
公开(公告)日：2013-09-19
申请号：PCT/KR2013/001980
申请日：2013-03-12
申请人： HANMI SCIENCE CO., LTD.
发明人： HUH, Yong Ho , OH, Euh Lim , JUNG, Sung Youb , KWON, Se Chang
IPC分类号： C12N1/21 , C12N15/70 , C12Q1/02
CPC分类号： C12P21/00 , C12N1/20
摘要： Disclosed is a method of culturing E. coli cells for high density, comprising a cell growth step and an expression induction step by which a maximum of cell mass can be obtained with the concomitant maximum expression of a recombinant protein. E. coli transformed to produce a recombinant protein of interest can be grown at a high concentration using the culturing method of the present invention. Therefore, the method increases the productivity of cells as well as the production yield of the recombinant protein, and can be widely applied to the effective production of recombinant proteins.
摘要翻译：公开了一种高密度培养大肠杆菌细胞的方法，包括细胞生长步骤和表达诱导步骤，通过该步骤可以通过重组蛋白的伴随最大表达获得最大的细胞团数。利用本发明的培养方法可以转化生产重组蛋白质的大肠杆菌以高浓度生长。因此，该方法提高了细胞的生产力以及重组蛋白的产量，可广泛应用于重组蛋白的有效生产。

24. 发明申请

WO2013100704A1 A SITE-SPECIFIC GLP-2 CONJUGATE USING AN IMMUNOGLOBULIN FRAGMENT 审中-公开
标题翻译：使用免疫球蛋白片段的特异性GLP-2凝集素
公开(公告)号：WO2013100704A1
公开(公告)日：2013-07-04
申请号：PCT/KR2012/011748
申请日：2012-12-28
申请人： HANMI SCIENCE CO., LTD.
发明人： KIM, Seung Su , LIM, Se Young , JUNG, Sung Youb , KWON, Se Chang
IPC分类号： A61K38/26 , A61K47/48 , A61K47/30 , A61P1/00
CPC分类号： A61K47/48415 , A61K38/26 , A61K47/48215 , A61K47/48369 , A61K47/60 , A61K47/68 , A61K47/6811
摘要： The present invention relates to a glucagon-like peptide-2 (GLP-2) conjugate comprising native GLP-2 or its derivative and an immunoglobulin Fc fragment being covalently linked via a non-peptidyl polymer, wherein the native GLP-2 or its derivative has a thiol group introduced at its C-terminal end, and one end of the non-peptidyl polymer is linked to an amino acid residue of the GLP-2 other than the N-terminal amino group thereof; a method for preparing the GLP-2 conjugate; a pharmaceutical composition comprising the same; and a method for treating or preventing intestinal disease, intestinal injury, or gastrosia by using the same. Since the GLP-2 conjugate of the present invention has a remarkably increased binding affinity to a GLP-2 receptor, it shows a prolonged in vivo half-life and an improved in vivo durability and stability.
摘要翻译：本发明涉及包含天然GLP-2或其衍生物的胰高血糖素样肽-2（GLP-2）结合物和通过非肽基聚合物共价连接的免疫球蛋白Fc片段，其中天然GLP-2或其衍生物在其C末端具有硫醇基，非肽基聚合物的一端与除了其N-末端氨基以外的GLP-2的氨基酸残基连接; 制备GLP-2缀合物的方法; 包含其的药物组合物; 以及通过使用该方法治疗或预防肠道疾病，肠损伤或胃癌的方法。由于本发明的GLP-2结合物对GLP-2受体的结合亲和力显着增加，因此其体内半衰期延长，体内耐久性和稳定性提高。

25. 发明申请

WO2013133667A1 PHARMACEUTICAL COMPOSITION FOR THE PREVENTION OR TREATMENT OF NON-ALCOHOLIC FATTY LIVER DISEASE 审中-公开
标题翻译：用于预防或治疗非酒精性脂肪肝疾病的药物组合物
公开(公告)号：WO2013133667A1
公开(公告)日：2013-09-12
申请号：PCT/KR2013/001897
申请日：2013-03-08
申请人： HANMI SCIENCE CO., LTD.
发明人： LIM, Se Young , PARK, Sung Hee , SHIN, Ryoung Ae , CHOI, In Young , KWON, Se Chang
IPC分类号： A61K38/17 , A61K38/16 , A61P1/16
CPC分类号： A61K47/48215 , A61K38/26 , A61K39/3955 , A61K47/60 , A61K47/6883 , A61K2039/505 , C07K14/605 , C07K16/18 , C07K2317/41 , C07K2317/75 , C07K2317/94
摘要： The present invention relates to a pharmaceutical composition for the prevention and treatment of non-alcoholic fatty liver disease (NAFLD), including a conjugate prepared by covalently linking an insulinotropic peptide, a non-peptidyl polymer and an immunoglobulin Fc region. The composition of the present invention maintains the in-vivo activity of the peptide at a relatively high level, and remarkably increases the blood half-life, thereby preventing triglyceride accumulation which is a typical feature of non-alcoholic fatty liver disease. Ultimately, it can be desirably employed for the prevention and treatment of non-alcoholic fatty liver disease.
摘要翻译：本发明涉及用于预防和治疗非酒精性脂肪肝疾病（NAFLD）的药物组合物，其包括通过共价连接促胰岛素肽，非肽基聚合物和免疫球蛋白Fc区而制备的缀合物。本发明的组合物将肽的体内活性维持在较高的水平，显着增加血液半衰期，从而防止作为非酒精性脂肪性肝病的典型特征的甘油三酯积聚。最终，可以理想地用于预防和治疗非酒精性脂肪性肝病。

26. 发明申请

WO2013100702A1 IMMUNOGLOBULIN FC VARIANTS 审中-公开
公开(公告)号：WO2013100702A1
公开(公告)日：2013-07-04
申请号：PCT/KR2012/011739
申请日：2012-12-28
申请人： HANMI SCIENCE CO., LTD.
发明人： OH, Euh Lim , HUH, Yong Ho , HWANG, Sang Youn , CHOI, In Young , JUNG, Sung Youb , KWON, Se Chang
IPC分类号： C07K16/28 , C07K19/00 , A61K39/395
CPC分类号： A61K47/48561 , A61K38/26 , A61K47/6849 , C07K16/00 , C07K16/283 , C07K2317/52 , C07K2317/92 , C07K2317/94 , C07K2319/00 , C07K2319/30
摘要： The present invention relates to immunoglobulin Fc variants having an increased binding affinity for FcRn, which is characterized by including one or more amino acid modifications selected from the group consisting of 307S, 308F, 380S, 380A, 428L, 429K, 430S, 433K and 434S (this numbering is according to the EU index) in the constant region of a native immunoglobulin Fc fragment. Owing to the high binding affinity for FcRn, the immunoglobulin Fc variants according to the present invention show more prolonged in vivo half-life, and thus can be used for the preparation of a long-acting formulation of protein drugs.
摘要翻译：本发明涉及对FcRn具有增加的结合亲和力的免疫球蛋白Fc变体，其特征在于包括一个或多个选自307S，308F，380S，380A，428L，429K，430S，433K和434S的氨基酸修饰（该编号根据EU指数）在天然免疫球蛋白Fc片段的恒定区中。由于对FcRn的高结合亲和力，根据本发明的免疫球蛋白Fc变体显示更长的体内半衰期，因此可用于制备蛋白质药物的长效制剂。

27. 发明申请

WO2012008779A2 A LIQUID FORMULATION OF LONG-ACTING HUMAN GROWTH HORMONE CONJUGATE 审中-公开
标题翻译：长寿命人体生长激素联合液的液体配方
公开(公告)号：WO2012008779A2
公开(公告)日：2012-01-19
申请号：PCT/KR2011/005194
申请日：2011-07-14
申请人： HANMI HOLDINGS CO., LTD. , HONG, Sung Hee , LEE, Byung Sun , IM, Dae Seong , LEE, Jae Min , BAE, Sung Min , KWON, Se Chang
发明人： HONG, Sung Hee , LEE, Byung Sun , IM, Dae Seong , LEE, Jae Min , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K9/08 , A61K9/22 , A61K38/27 , A61K47/36
CPC分类号： A61K47/48415 , A61K9/0019 , A61K9/08 , A61K38/27 , A61K47/12 , A61K47/26 , A61K47/60 , A61K47/68 , C07K2319/30
摘要： Disclosed is a liquid formulation of long-acting human growth hormone (hGH) conjugate, free of albumin, which can guarantee the stability of the long-acting hGH conjugate when stored over a long period of time, wherein the long-acting human growth hormone conjugate includes a human growth hormone linked to an immunoglobulin Fc region, and has a prolonged in vivo stability compared to the native form. The liquid formulation of hGH conjugate including a pH 5.0~6.0 buffer, a sugar alcohol, a salt and a non-ionic surfactant is free of human serum albumin and other hazardous factors which are potentially contaminated with viruses, and can provide excellent storage stability customized for a long-acting hGH conjugate composed of an hGH polypeptide and an immunoglobulin Fc region which has higher molecular weight and in vivo durability, compared to the native.
摘要翻译：公开了长效人生长激素（hGH）缀合物的液体制剂，其不含白蛋白，其可以长期保存长效hGH缀合物的稳定性，其中长效人生长激素缀合物包括与免疫球蛋白Fc区连接的人生长激素，并且与天然形式相比具有延长的体内稳定性。包含pH 5.0〜6.0缓冲液，糖醇，盐和非离子表面活性剂的hGH缀合物的液体制剂不含人血清白蛋白和其他可能被病毒污染的危险因素，可提供优良的储存稳定性对于由hGH多肽和具有较高分子量和体内耐久性的免疫球蛋白Fc区组成的长效hGH缀合物，与天然产物相比。

28. 发明申请

WO2008048037A1 A NOVEL VECTOR AND EXPRESSION CELL LINE FOR MASS PRODUCTION OF RECOMBINANT PROTEIN AND A PROCESS OF PRODUCING RECOMBINANT PROTEIN USING SAME 审中-公开
标题翻译：用于生产重组蛋白质的新型载体和表达细胞系以及使用其生产重组蛋白的方法
公开(公告)号：WO2008048037A1
公开(公告)日：2008-04-24
申请号：PCT/KR2007/005064
申请日：2007-10-16
申请人： HANMI PHARMACEUTICAL CO., LTD. , CHOI, In Young , KIM, Chang Hwan , LEE, Hyun Ji , PARK, Seong Hee , KWON, Se Chang , LEE, Gwan Sun
发明人： CHOI, In Young , KIM, Chang Hwan , LEE, Hyun Ji , PARK, Seong Hee , KWON, Se Chang , LEE, Gwan Sun
IPC分类号： C12N15/63 , C12N15/79 , C12N15/09
CPC分类号： C12N9/003 , C12N15/85 , C12N2510/00
摘要： Disclosed herein is an inducible high-expression cassette comprising a dihydrofolate reductase (DHFR) promoter from which GC-rich repeat sequences are partially or entirely removed, the cassette capable of more effectively improving a gene amplification system. Also disclosed are an expression vector comprising the inducible expression cassette and optionally a gene encoding a recombinant protein of interest, an animal cell line transformed with the expression vector, and a method of mass producing and purifying a recombinant protein by culturing the transformant. The present invention enables the shortening of the time required to establish a cell line producing a recombinant protein of interest at high levels using a low concentration of a DHFR inhibitor, thereby allowing more effective production of the recombinant protein.
摘要翻译：本文公开了包含二氢叶酸还原酶（DHFR）启动子的诱导型高表达盒，从其中部分或全部除去富含GC的重复序列，所述盒能够更有效地改善基因扩增系统。还公开了包含可诱导表达盒和任选的编码目标重组蛋白的基因，用表达载体转化的动物细胞系的表达载体，以及通过培养转化体大量生产和纯化重组蛋白的方法。本发明能够缩短使用低浓度的DHFR抑制剂以高水平建立产生重组蛋白质的细胞系所需的时间，从而允许更有效地产生重组蛋白质。

29. 发明申请

WO2011090305A3 LIQUID FORMULATIONS FOR LONG-ACTING G-CSF CONJUGATE 审中-公开
公开(公告)号：WO2011090305A3
公开(公告)日：2011-07-28
申请号：PCT/KR2011/000369
申请日：2011-01-18
申请人： HANMI HOLDINGS CO., LTD , LEE, Mi Ji , LEE, Jae Min , LEE, Byung Sun , BAE, Sung Min , KWON, Se Chang
发明人： LEE, Mi Ji , LEE, Jae Min , LEE, Byung Sun , BAE, Sung Min , KWON, Se Chang
IPC分类号： A61K9/38 , A61K9/08 , A61K9/14 , A61K47/42
摘要： Disclosed is a liquid formulation which allows long-acting G-CSF conjugates, that have improved in vivo duration and stability, to be stable when stored for a long period of time. It comprises a stabilizer composition characterized by buffer and mannitol. Being free of human serum albumin and other potential factors harmful to the body, the liquid formulation is free of concerns about viral infections and guarantees excellent storage stability to long-acting G-CSF conjugates.

30. 发明申请

WO2010011096A2 A POLYPEPTIDE COMPLEX COMPRISING NON-PEPTIDYL POLYMER HAVING THREE FUNCTIONAL ENDS 审中-公开
标题翻译：包含具有三个功能末端的非肽聚合物的多肽复合物
公开(公告)号：WO2010011096A2
公开(公告)日：2010-01-28
申请号：PCT/KR2009/004114
申请日：2009-07-23
申请人： HANMI PHARMACEUTICAL CO., LTD. , SONG, Dae Hae , SHIN, Jae Hee , LEE, Mi Ji , HONG, Sung Hee , KWON, Se Chang , LEE, Gwan Sun
发明人： SONG, Dae Hae , SHIN, Jae Hee , LEE, Mi Ji , HONG, Sung Hee , KWON, Se Chang , LEE, Gwan Sun
IPC分类号： C07K19/00
CPC分类号： A61K47/48715 , A61K47/60 , A61K47/6811 , A61K47/6889 , C07K14/59 , C07K19/00 , C07K2319/31
摘要： Disclosed is a protein complex, comprising a physiologically active polypeptide, a dimeric protein and a non-peptidyl polymer having three functional ends(3-arm), with the linkage of both the physiologically active polypeptide and the dimeric protein to the 3-arm non-peptidyl polymer via respective covalent bonds. The protein complex guarantees the long acting activity and biostability of a physiologically active polypeptide. Having the ability to maintain the bioactivity of physiologically active polypeptides or peptides highly and to significantly improve the serum half life of the polypeptides or peptides, the protein complex can be applied to the development of sustained release formulations of various physiologically active polypeptide drugs. Also, it utilizes raw materials including the physiologically active polypeptides without significant loss, thereby increasing the production yield. Further, it can be easily purified.
摘要翻译：公开了一种蛋白质复合物，其包含生理活性多肽，二聚体蛋白质和具有三个功能末端（3-臂）的非肽基聚合物，其具有生理活性多肽和二聚体蛋白质与3-臂非 - - 肽基聚合物。蛋白质复合物保证生理活性多肽的长效和生物稳定性。具有维持生理活性多肽或肽的生物活性以及显着改善多肽或肽的血清半衰期的能力，蛋白质复合物可用于开发各种生理活性多肽药物的持续释放制剂。此外，它利用包括生理活性多肽的原料，而不会显着损失，从而提高产量。此外，它可以容易地纯化。

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