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1. 发明申请

US20160008484A1 IMPROVED PREPARATION METHOD FOR HIGH-YIELD PRODUCTION OF PHYSIOLOGICALLY ACTIVE POLYPEPTIDE CONJUGATE 审中-公开
标题翻译：生物活性多肽共聚物高效生产的改进制备方法
公开(公告)号：US20160008484A1
公开(公告)日：2016-01-14
申请号：US14772493
申请日：2014-03-05
申请人： HANMI PHARM. CO., LTD.
发明人： Myung Hyun JANG , Min Young KIM , Dae Jin KIM , Sung Youb JUNG , Se Chang KWON
IPC分类号： A61K47/48 , A61K38/28
摘要： Provided is a method for preparing a conjugate by linking a physiologically active polypeptide, a non-peptidyl polymer linker, and an immunoglobulin constant region via a covalent bond. The method for efficiently preparing the physiologically active polypeptide conjugate uses a salt in a coupling reaction to solve the problem of low production yield during preparation of the physiologically active polypeptide conjugate. The conjugate of physiologically active polypeptide-non-peptidyl polymer-immunoglobulin constant region can be produced with high purity and yield by the subject method. Due to the method for preparing the physiologically active polypeptide conjugate, production costs can be reduced. Therefore, the method can be used to develop long-acting formulations of physiologically active polypeptides, which have improved industrial applicability and drug regulation compliance.
摘要翻译：提供通过共价键连接生理活性多肽，非肽基聚合物接头和免疫球蛋白恒定区来制备缀合物的方法。用于有效制备生理活性多肽缀合物的方法使用耦合反应中的盐来解决制备生理活性多肽缀合物期间产量低的问题。生理活性多肽 - 非肽基聚合物 - 免疫球蛋白恒定区的缀合物可以通过本发明方法以高纯度和产率产生。由于制备生理活性多肽缀合物的方法，可以降低生产成本。因此，该方法可用于开发具有改善的工业适用性和药物调节依从性的生理活性多肽的长效制剂。

2. 发明公开

US20230220034A1 METHOD FOR IMPROVING SOLUBILITY OF PROTEIN AND PEPTIDE BY USING IMMUNOGLOGULIN FC FRAGMENT LINKAGE 审中-公开
公开(公告)号：US20230220034A1
公开(公告)日：2023-07-13
申请号：US17839053
申请日：2022-06-13
申请人： HANMI PHARM. CO., LTD.
发明人： Hyung Kyu LIM , Jong Soo LEE , Dae Jin KIM , Sung Min BAE , Sung Youb JUNG , Se Chang KWON
IPC分类号： C07K14/605 , A61K38/28 , C07K14/62 , C07K1/107 , A61K38/29 , A61K38/26 , A61K9/08
CPC分类号： C07K14/605 , A61K38/28 , C07K14/62 , C07K1/1075 , A61K38/29 , A61K38/26 , A61K9/08 , C07K2319/00 , C07K2319/30
摘要： A method for improving the solubility of a physiologically active protein or peptide compared to that of a physiologically active protein or peptide which is not conjugated to an immunoglobulin Fc fragment is disclosed. The method includes steps of conjugating the physiologically active protein or peptide to an immunoglobulin Fc fragment. Also disclosed is a composition for improving the solubility of a physiologically active protein or peptide, which contains an immunoglobulin Fc fragment. The composition improves the solubility compared to a composition without an immunoglobulin Fc fragment.

3. 发明申请

US20230139745A1 NON-PEPTIDIC POLYMERIC LINKER COMPOUND, CONJUGATE COMPRISING SAME LINKER COMPOUND, AND METHODS FOR PREPARING SAME LINKER COMPOUND AND CONJUGATE 有权
公开(公告)号：US20230139745A1
公开(公告)日：2023-05-04
申请号：US16484290
申请日：2018-02-07
申请人： HANMI PHARM. CO., LTD.
发明人： Su Yeon PARK , Dae Jin KIM , Sung Youb JUNG , Yong Gyu JUNG , Hyun Sik YUN
IPC分类号： A61K47/68
摘要： One aspect of the present invention provides a compound in which a functional group capable of binding to a globulin Fc region or a physiologically active polypeptide is introduced at one end of a non-peptidic polymer and a functional group capable of a click reaction is introduced at the other end; a polypeptide conjugate in which a physiologically active polypeptide binds to one end of the compound; a physiologically active polypeptide conjugate in which a physiologically active polypeptide and an immunoglobulin Fc region bind to both ends thereof by using the compound as a linker; and methods for preparing the same compound, polypeptide conjugate, and physiologically active polypeptide conjugate.

4. 发明申请

US20220249615A1 PROTEIN COMPLEX BY USE OF A SPECIFIC SITE OF AN IMMUNOGLOBULIN FRAGMENT FOR LINKAGE 有权
公开(公告)号：US20220249615A1
公开(公告)日：2022-08-11
申请号：US17730510
申请日：2022-04-27
申请人： HANMI PHARM. CO., LTD
发明人： Dae Jin KIM , Jong Soo LEE , Young Jin PARK , Sung Hee HONG , Sung Min BAE , Se Chang KWON
IPC分类号： A61K38/21 , A61K47/68 , C07K14/535 , A61K47/60
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 may be usefully applied to the development of long-acting formulations of various physiologically active polypeptide drugs.

5. 发明申请

US20200276317A1 PROTEIN COMPLEX COMPRISING NON-PEPTIDYL POLYMER-COUPLED FATTY ACID DERIVATIVE COMPOUND AS LINKER AND PREPARATION METHOD THEREFOR 审中-公开
公开(公告)号：US20200276317A1
公开(公告)日：2020-09-03
申请号：US16647115
申请日：2018-10-01
申请人： HANMI PHARM. CO., LTD.
发明人： Su Yeon PARK , Ji Young SONG , Eun Jung KIM , Jong Min LEE , Jong-Soo LEE , Dae Jin KIM
IPC分类号： A61K47/56 , A61K47/54 , C07K14/62
摘要： Provided are a protein conjugate in which a physiologically active polypeptide is linked to a biocompatible material via a non-peptidyl polymer-coupled fatty acid derivative compound serving as a linker, exhibiting an increased duration of physiological activity compared to natural forms and a preparation method therefor. Since an increase in serum half-life of the physiologically active polypeptide of the protein conjugate, in which the biocompatible material, the non-peptidyl polymer-coupled fatty acid derivative compound, and the physiologically active polypeptide are linked, is proved, the protein conjugate may be widely used in the field of protein drugs.

6. 发明申请

US20180015175A1 LIQUID FORMULATION OF LONG ACTING INSULINOTROPIC PEPTIDE CONJUGATE 审中-公开
公开(公告)号：US20180015175A1
公开(公告)日：2018-01-18
申请号：US15714556
申请日：2017-09-25
申请人： HANMI PHARM. CO., LTD.
发明人： Hyun Uk KIM , Hyung Kyu LIM , Sung Hee HONG , Dae Jin KIM , Sung Min BAE , Se Chang KWON
IPC分类号： C07K16/28 , C07K16/42 , G01N33/50 , C07K16/06 , C07K19/00
CPC分类号： A61K47/68 , A61K9/08 , A61K39/39591 , A61K47/26 , A61K47/6811 , C07K14/57563 , C07K14/605 , C07K16/065 , C07K16/28 , C07K16/4283 , C07K19/00 , C07K2317/50 , C07K2319/30 , G01N33/5047
摘要： Provided are a liquid formulation of long-acting insulinotropic peptide conjugate, containing 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, and a non-ionic surfactant, 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.

7. 发明申请

US20170128589A1 METHOD FOR IMPROVING SOLUBILITY OF PROTEIN AND PEPTIDE BY USING IMMUNOGLOGULIN FC FRAGMENT LINKAGE 审中-公开
公开(公告)号：US20170128589A1
公开(公告)日：2017-05-11
申请号：US15129897
申请日：2015-03-31
申请人： HANMI PHARM. CO., LTD.
发明人： Hyung Kyu LIM , Jong Soo LEE , Dae Jin KIM , Sung Min BAE , Sung Youb JUNG , Se Chang KWON
IPC分类号： C07K16/00 , A61K38/28 , A61K38/26 , C07K14/605 , A61K9/08 , C07K14/62
CPC分类号： C07K14/605 , A61K9/08 , A61K38/26 , A61K38/28 , A61K38/29 , C07K1/1075 , C07K14/62 , C07K2319/00 , C07K2319/30
摘要： The present invention relates to a method for improving the solubility of a physiologically active protein or peptide compared to that of a physiologically active protein or peptide which is not conjugated to an immunoglobulin Fc fragment, in which the method comprises conjugating the physiologically active protein or peptide to an immunoglobulin Fc fragment; and a composition for improving the solubility of a physiologically active protein or peptide, comprising an immunoglobulin Fc fragment, in which the composition improves the solubility compared to a composition without an immunoglobulin Fc fragment.

8. 发明公开

US20230212103A1 POLYETHYLENE GLYCOL DERIVATIVE AND USE THEREOF 审中-公开
公开(公告)号：US20230212103A1
公开(公告)日：2023-07-06
申请号：US18085341
申请日：2022-12-20
申请人： HANMI PHARM. CO., LTD.
发明人： Dae Jin KIM , Jong Soo LEE , SungMin BAE , Se Chang KWON
IPC分类号： C07C47/198 , A61K39/395 , C07C323/22 , C07C323/39 , C07C233/05 , A61K47/50 , C07C237/04 , A61K38/18 , A61K47/60 , C07C233/18 , C07C323/12 , C07D213/71
CPC分类号： C07C47/198 , A61K39/395 , C07C323/22 , C07C323/39 , C07C233/05 , A61K47/50 , C07C237/04 , A61K38/18 , A61K47/60 , C07C233/18 , C07C323/12 , C07D213/71
摘要： Polyethylene glycol derivatives of the following formula I and uses thereof are disclosed. A method for manufacturing the polyethylene glycol derivatives is also disclosed.

9. 发明申请

US20180161448A1 LONG-ACTING INSULIN OR INSULIN ANALOGUE CONJUGATE 审中-公开
公开(公告)号：US20180161448A1
公开(公告)日：2018-06-14
申请号：US15551489
申请日：2016-02-17
申请人： HANMI PHARM. CO., LTD.
发明人： Yong Ho HEO , Jong Soo LEE , Sung Hee PARK , Dae Jin KIM , Sung Youb JUNG , Se Chang KWON
IPC分类号： A61K47/68 , C07K14/62 , A61K47/60 , A61P3/10 , C12N15/67
CPC分类号： A61K47/6811 , A61K38/00 , A61K38/28 , A61K47/50 , A61K47/60 , A61P3/10 , C07K14/62 , C07K2317/52 , C07K2317/522 , C07K2317/524 , C07K2317/526 , C07K2317/528 , C07K2317/53 , C07K2319/30 , C12N15/67 , C12N2840/203
摘要： The present invention relates to insulin and/or an insulin analogue conjugate, and a use thereof, wherein the insulin and/or insulin analogue have improved in vivo durability and stability by linking the same with an Fe region of immunoglobulin. The insulin and/or an insulin analogue conjugate of the present invention show an in vivo activity similar to that of insulin. In addition, the insulin and/or insulin analogue conjugate of the present invention are long-acting formulations of insulin and/or the analogue thereof, in which serum half-life is remarkably increased, and therefore, the present invention provides remarkable insulin and/or an insulin analogue conjugate, which do not induce hypoglycemia, a drawback of insulin treatment.

10. 发明申请

US20170143802A1 COMPOSITION FOR TREATING DIABETES COMPRISING LONG-ACTING INSULIN ANALOGUE CONJUGATE AND LONG-ACTING INSULINOTROPIC PEPTIDE CONJUGATE 审中-公开
公开(公告)号：US20170143802A1
公开(公告)日：2017-05-25
申请号：US15313501
申请日：2015-05-29
申请人： HANMI PHARM. CO., LTD.
发明人： Jung Kuk KIM , Dae Jin KIM , Yong Ho HEO , In Young CHOI , Sung Youb JUNG , Se Chang KWON
IPC分类号： A61K38/28 , C07K16/28 , A61K38/26
CPC分类号： A61K38/28 , A61K38/26 , A61K47/30 , A61K47/50 , A61K47/60 , A61K47/6849 , C07K16/283
摘要： The present invention relates to a composition for the prevention or treatment of diabetes including a long-acting insulin conjugate and a long-acting insulinotropic peptide conjugate, and a method for treating diabetes. More specifically, combination administration of the long-acting analogue conjugate and the long-acting insulinotropic peptide conjugate inhibits weight gain due to administration of insulin, and vomiting and nausea due to administration of the insulinotropic peptide, and also reduces the required doses of insulin, thereby remarkably improving drug compliance. In addition, the present invention relates to administering a pharmaceutical composition for reducing side effects of pancreatic beta cells in diabetic patients, including a long-acting insulin analogue conjugate and a long-acting insulinotropic peptide analogue conjugate, and to a method for reducing side effects of pancreatic beta cells in diabetic patients, including the step of administering the composition. Specifically, the present invention is characterized in reducing side effects such as abnormality in the function of pancreatic beta cells associated with the development of diabetes, reduction in the pancreatic beta cell mass, lipotoxicity, or glucotoxicity.

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