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公开(公告)号：EP4149519A1
公开(公告)日：2023-03-22
申请号：EP21804731.4
申请日：2021-05-14
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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：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：EP3436577A1
公开(公告)日：2019-02-06
申请号：EP17720281.9
申请日：2017-03-30
发明人： DO, Hung V. , GOTSCHALL, Russell
IPC分类号： C12N9/26
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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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7.发明公开
公开(公告)号：EP3201320A1
公开(公告)日：2017-08-09
申请号：EP15845664.0
申请日：2015-09-30
发明人： GOTSCHALL, Russell , DO, Hung
CPC分类号： C12N9/2465 , A61K48/005 , C12N15/09 , C12N2510/02 , C12Y302/0102
摘要： Recombinant human alpha glucosidase (rhGAA) composition derived from CHO cells that contains a more optimized glycan composition consisting of a higher amount of rhGAA containing N-glycans carrying mannose-6-phosphate (M6P) or bis-M6P than conventional rhGAAs, along with low amount of non-phosphorylated high mannose glycans, and low amount of terminal galactose on complex oligosaccharides. Compositions containing the rhGAA, and methods of use are described.
摘要翻译： 由CHO细胞衍生的重组人α葡糖苷酶（rhGAA）组合物，其含有更优化的聚糖组合物，其由比常规rhGAA含有更高量的含有携带甘露糖-6-磷酸（M6P）或bis-M6P的N-聚糖组成的rhGAA以及低 非磷酸化高甘露糖聚糖的量和复合寡糖上低量的末端半乳糖。 描述了含有rhGAA的组合物和使用方法。
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公开(公告)号：EP4291225A1
公开(公告)日：2023-12-20
申请号：EP22753411.2
申请日：2022-02-11
发明人： DO, Hung , GOTSCHALL, Russell , CHAR, Hing , BARTH, Jay
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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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