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公开(公告)号：EP3436053A1
公开(公告)日：2019-02-06
申请号：EP17719388.5
申请日：2017-03-30
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公开(公告)号：EP3624831A1
公开(公告)日：2020-03-25
申请号：EP18802722.1
申请日：2018-05-15
发明人： DO, Hung , GOTSCHALL, Russell , KHANNA, Richie , LUN, Yi , CHAR, Hing , TESLER, Sergey , SUNDERLAND, Wendy , DILON , Enrique
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公开(公告)号：EP2943200A1
公开(公告)日：2015-11-18
申请号：EP14738292.3
申请日：2014-01-09
发明人： CHAR, Hing , TESLER, Sergey , YANG, Jiping , DILONE, Enrique
IPC分类号： A61K31/445
摘要： A stable pharmaceutical composition that includes an active agent selected from 1-deoxynojirimycin, a pharmaceutically acceptable salt thereof, or a derivative thereof, and a buffer, wherein the stable pharmaceutical composition is capable of being parenterally administered to a human without deleterious health effects. Pompe disease is an example of a lysosomal storage disorder. Pompe disease is caused by a deficiency in the enzyme acid alpha-glucosidase (GAA). GAA metabolizes glycogen, a storage form of sugar used for energy, into glucose.
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公开(公告)号：EP4263505A1
公开(公告)日：2023-10-25
申请号：EP21841141.1
申请日：2021-12-16
发明人： SHETH, Kamlesh , TESLER, Sergey
IPC分类号： C07D211/46 , B01D9/02
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公开(公告)号：EP4098274A1
公开(公告)日：2022-12-07
申请号：EP22165645.7
申请日：2017-03-30
发明人： CHAR, Hing , TESLER, Sergey , SUNDERLAND, Wendy , DILONE, Enrique , DO, Hung , GOTSCHALL, Russell
摘要： Provided are pharmaceutical formulations comprising a recombinant acid α-glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa; at least one buffer selected from the group consisting of a citrate, a phosphate and combinations thereof; and at least one excipient selected from the group consisting of mannitol, polysorbate 80, and combinations thereof, wherein the formulation has a pH of from about 5.0 to about 7.0. Also provided are methods of treating Pompe disease using these pharmaceutical formulations.
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公开(公告)号：EP2943200B9
公开(公告)日：2020-07-22
申请号：EP14738292.3
申请日：2014-01-09
发明人： CHAR, Hing , TESLER, Sergey , YANG, Jiping , DILONE, Enrique
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公开(公告)号：EP4223310A3
公开(公告)日：2023-10-11
申请号：EP23164670.4
申请日：2018-05-15
发明人： DO, Hung , GOTSCHALL, Russell , KHANNA, Richie , LUN, Yi , CHAR, Hing , TESLER, Sergey , SUNDERLAND, Wendy , DILONÉ, Enrique
摘要： Provided are a recombinant acid α-glucosidase and pharmaceutical composition comprising a recombinant acid α- glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa. Also provided herein are methods of producing, purifying, and formulating the recombinant acid α-glucosidase or pharmaceutical composition for administration to a subject and methods of treating a disease or disorder such as Pompe disease using the recombinant acid α-glucosidase or pharmaceutical composition.
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公开(公告)号：EP4223310A2
公开(公告)日：2023-08-09
申请号：EP23164670.4
申请日：2018-05-15
发明人： DO, Hung , GOTSCHALL, Russell , KHANNA, Richie , LUN, Yi , CHAR, Hing , TESLER, Sergey , SUNDERLAND, Wendy , DILONÉ, Enrique
摘要： Provided are a recombinant acid α-glucosidase and pharmaceutical composition comprising a recombinant acid α- glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa. Also provided herein are methods of producing, purifying, and formulating the recombinant acid α-glucosidase or pharmaceutical composition for administration to a subject and methods of treating a disease or disorder such as Pompe disease using the recombinant acid α-glucosidase or pharmaceutical composition.
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公开(公告)号：EP2943200B1
公开(公告)日：2019-12-18
申请号：EP14738292.3
申请日：2014-01-09
发明人： CHAR, Hing , TESLER, Sergey , YANG, Jiping , DILONE, Enrique
IPC分类号： A61K31/445 , A61P21/00 , A61P25/00 , A61P43/00 , A61P9/00 , A61K9/00 , A61K47/02 , A61K47/12 , A61K47/18 , A61K31/45
摘要： A stable pharmaceutical composition that includes an active agent selected from 1-deoxynojirimycin, a pharmaceutically acceptable salt thereof, or a derivative thereof, and a buffer, wherein the stable pharmaceutical composition is capable of being parenterally administered to a human without deleterious health effects. Pompe disease is an example of a lysosomal storage disorder. Pompe disease is caused by a deficiency in the enzyme acid alpha-glucosidase (GAA). GAA metabolizes glycogen, a storage form of sugar used for energy, into glucose.
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