TWI761453B - 抗rsv單株抗體配製物 - Google Patents
抗rsv單株抗體配製物 Download PDFInfo
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- TWI761453B TWI761453B TW107105368A TW107105368A TWI761453B TW I761453 B TWI761453 B TW I761453B TW 107105368 A TW107105368 A TW 107105368A TW 107105368 A TW107105368 A TW 107105368A TW I761453 B TWI761453 B TW I761453B
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Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762465379P | 2017-03-01 | 2017-03-01 | |
| US62/465,379 | 2017-03-01 |
Publications (2)
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| TW201840334A TW201840334A (zh) | 2018-11-16 |
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| MX374517B (es) | 2014-01-15 | 2025-03-06 | Medimmune Ltd | Anticuerpos especificos del virus respiratorio sincitial (vrs) y partes funcionales de los mismos. |
| EP3383435A4 (en) * | 2015-11-30 | 2019-07-10 | Medimmune, LLC | OPTIMIZED RATES OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS HAVING HIGH CONCENTRATIONS IN PROTEIN-BASED THERAPEUTICS |
| TWI761453B (zh) * | 2017-03-01 | 2022-04-21 | 英商梅迪繆思有限公司 | 抗rsv單株抗體配製物 |
| MX2019010282A (es) * | 2017-03-01 | 2020-01-09 | Medimmune Ltd | Formulacion de anticuerpos monoclonales. |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| CA3060581A1 (en) | 2017-05-02 | 2018-11-08 | Merck Sharp & Dohme Corp. | Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies |
| WO2020081408A1 (en) * | 2018-10-18 | 2020-04-23 | Merck Sharp & Dohme Corp. | Formulations of anti-rsv antibodies and methods of use thereof |
| MX2021005394A (es) | 2018-11-07 | 2021-07-06 | Merck Sharp & Dohme Llc | Co-formulaciones de anticuerpos anti-gen de activacion de linfocitos 3 (anti-lag3) y anticuerpos anti-muerte programada-1 (anti-pd-1). |
| MA55033A (fr) | 2019-02-18 | 2021-12-29 | Lilly Co Eli | Formulation d'anticorps thérapeutique |
| CN113993884A (zh) * | 2019-04-18 | 2022-01-28 | 弗劳恩霍夫应用研究促进协会 | 抑制呼吸道合胞病毒感染的生物及合成分子 |
| US12024553B2 (en) | 2019-04-30 | 2024-07-02 | Medimmune Limited | Dosage regimens for and compositions including anti-RSV antibodies |
| EP4045533B1 (en) | 2020-03-26 | 2023-11-15 | Vanderbilt University | Human monoclonal antibodies to severe acute respiratory syndrome coronavirus 2 (sars-cov-2) |
| US11912764B2 (en) * | 2020-07-31 | 2024-02-27 | Alamab Therapeutics, Inc. | Anti-connexin antibody formulations |
| CN115960214A (zh) * | 2021-10-12 | 2023-04-14 | 中国科学院分子细胞科学卓越创新中心 | 中和呼吸道合胞病毒的全人抗体的设计及应用 |
| TW202342510A (zh) | 2022-02-18 | 2023-11-01 | 英商Ｒｑ生物科技有限公司 | 抗體 |
| CN116987183B (zh) * | 2022-07-22 | 2024-10-15 | 北京智仁美博生物科技有限公司 | 抗呼吸道合胞病毒中和性抗体及其用途 |
| EP4631974A1 (en) * | 2022-12-08 | 2025-10-15 | Nanjing Vazyme Biotech Co., Ltd. | Antibody specifically binding to rsv |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040170623A1 (en) * | 2001-05-31 | 2004-09-02 | Tudor Arvinte | Stable liquid formulations of antibodies |
| US20120121580A1 (en) * | 2009-07-28 | 2012-05-17 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
Family Cites Families (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5892019A (en) | 1987-07-15 | 1999-04-06 | The United States Of America, As Represented By The Department Of Health And Human Services | Production of a single-gene-encoded immunoglobulin |
| US5811524A (en) | 1995-06-07 | 1998-09-22 | Idec Pharmaceuticals Corporation | Neutralizing high affinity human monoclonal antibodies specific to RSV F-protein and methods for their manufacture and therapeutic use thereof |
| CA2230127A1 (en) | 1995-09-18 | 1997-03-27 | Intracel Corporation | Neutralizing monoclonal antibodies to respiratory syncytial virus |
| CA2466034C (en) * | 2001-11-08 | 2012-12-18 | Protein Design Labs, Inc. | Stable aqueous pharmaceutical formulations of daclizumab antibodies |
| US7425618B2 (en) * | 2002-06-14 | 2008-09-16 | Medimmune, Inc. | Stabilized anti-respiratory syncytial virus (RSV) antibody formulations |
| US7132100B2 (en) * | 2002-06-14 | 2006-11-07 | Medimmune, Inc. | Stabilized liquid anti-RSV antibody formulations |
| AU2013201261B2 (en) * | 2002-06-14 | 2016-06-23 | Medimmune, Llc | Stabilized liquid anti-RSV antibody formulations |
| BRPI0403964B8 (pt) * | 2003-04-04 | 2021-05-25 | Genentech Inc | formulações líquidas estáveis, artigo manufaturado e uso dessas formulações para o tratamento de disfunção mediada por ige |
| TW200636064A (en) | 2004-10-28 | 2006-10-16 | Centocor Inc | Anti-respiratory syncytial virus antibodies, antigens and uses thereof |
| AU2007223903B2 (en) * | 2006-03-06 | 2013-09-05 | Medimmune, Llc | Humanized anti-CD22 antibodies and their use in treatment of oncology, transplantation and autoimmune disease |
| EP1997830A1 (en) | 2007-06-01 | 2008-12-03 | AIMM Therapeutics B.V. | RSV specific binding molecules and means for producing them |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| RU2011122615A (ru) | 2008-11-05 | 2012-12-20 | Мерк Шарп Энд Домэ Корп. | Живой аттенуированный респираторно-синцитиальный вирус |
| US8568726B2 (en) | 2009-10-06 | 2013-10-29 | Medimmune Limited | RSV specific binding molecule |
| NZ599148A (en) | 2009-10-06 | 2014-08-29 | Medimmune Ltd | Rsv-specific binding molecule |
| CL2011003002A1 (es) | 2011-11-25 | 2012-05-25 | Univ Pontificia Catolica Chile | Anticuerpo monoclonal o un fragmento del mismo que se une a la proteina m2-1 del virus respiratorio sincicial (vrs) humano; secuencias nucleotidicas; composicion farmaceutica; metodo de diagnostico de infeccion producida por vrs; kit; y uso de dicho anticuerpo para preparar un medicamento. |
| JP6265970B2 (ja) * | 2012-03-26 | 2018-01-24 | サノフイ | 安定なＩｇＧ４に基づく結合剤の製剤 |
| US20140004131A1 (en) | 2012-05-04 | 2014-01-02 | Novartis Ag | Antibody formulation |
| US8883979B2 (en) * | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| JP6450688B2 (ja) | 2013-02-01 | 2019-01-09 | メディミューン，エルエルシー | 呼吸器合胞体ウイルスｆタンパク質エピトープ |
| MX374517B (es) * | 2014-01-15 | 2025-03-06 | Medimmune Ltd | Anticuerpos especificos del virus respiratorio sincitial (vrs) y partes funcionales de los mismos. |
| WO2016059512A1 (en) * | 2014-10-18 | 2016-04-21 | Pfizer Inc. | Anti-il-7r antibody compositions |
| AU2016289492B2 (en) | 2015-07-07 | 2022-08-11 | Janssen Vaccines & Prevention B.V. | Vaccine against RSV |
| JO3555B1 (ar) | 2015-10-29 | 2020-07-05 | Merck Sharp & Dohme | جسم مضاد يبطل فعالية فيروس الالتهاب الرئوي البشري |
| TWI761453B (zh) * | 2017-03-01 | 2022-04-21 | 英商梅迪繆思有限公司 | 抗rsv單株抗體配製物 |
| MX2019010282A (es) * | 2017-03-01 | 2020-01-09 | Medimmune Ltd | Formulacion de anticuerpos monoclonales. |
| US12024553B2 (en) * | 2019-04-30 | 2024-07-02 | Medimmune Limited | Dosage regimens for and compositions including anti-RSV antibodies |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040170623A1 (en) * | 2001-05-31 | 2004-09-02 | Tudor Arvinte | Stable liquid formulations of antibodies |
| US20120121580A1 (en) * | 2009-07-28 | 2012-05-17 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
Non-Patent Citations (1)
| Title |
|---|
| 期刊韕Wang, Shujing, et al. 韕 韕Molecular pharmaceutics韕12.韕12韕2015韕4478-4487.韕 * |
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