KR20180106974A - 항-tnf 알파 항체의 액상 제제 - Google Patents

항-tnf 알파 항체의 액상 제제 Download PDF

Info

Publication number: KR20180106974A
Authority: KR; South Korea
Prior art keywords: formulation; arginine; liquid formulation; concentration; sucrose
Prior art date: 2017-03-16
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Ceased

Application number

KR1020180031016A

Other languages

English (en)

Korean (ko)

Inventor

윤소라

고연경

소진언

Original Assignee

주식회사 엘지화학

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2017-03-16

Filing date

2018-03-16

Publication date

2018-10-01

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63522490&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR20180106974(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2018-03-16 Application filed by 주식회사 엘지화학 filed Critical 주식회사 엘지화학

2018-10-01 Publication of KR20180106974A publication Critical patent/KR20180106974A/ko

2020-08-05 Priority to KR1020200098144A priority Critical patent/KR102342292B1/ko

Status Ceased legal-status Critical Current

Images

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K40/00—Cellular immunotherapy
- A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
- A61K40/41—Vertebrate antigens
- A61K40/42—Cancer antigens
- A61K40/4231—Cytokines
- A61K40/4232—Tumor necrosis factors [TNF] or CD70
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Medicinal Chemistry (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
Epidemiology (AREA)
Pharmacology & Pharmacy (AREA)
Engineering & Computer Science (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
Immunology (AREA)
Mycology (AREA)
Microbiology (AREA)
Bioinformatics & Cheminformatics (AREA)
Biochemistry (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Molecular Biology (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Medicinal Preparation (AREA)
Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Endocrinology (AREA)
Biomedical Technology (AREA)
Oncology (AREA)
Peptides Or Proteins (AREA)

KR1020180031016A 2017-03-16 2018-03-16 항-tnf 알파 항체의 액상 제제 Ceased KR20180106974A (ko)

Priority Applications (1)

Application Number	Priority Date	Filing Date	Title
KR1020200098144A KR102342292B1 (ko)	2017-03-16	2020-08-05	항-tnf 알파 항체의 액상 제제

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
KR1020170033188		2017-03-16
KR20170033188		2017-03-16

Related Child Applications (1)

Application Number	Title	Priority Date	Filing Date
KR1020200098144A Division KR102342292B1 (ko)	2017-03-16	2020-08-05	항-tnf 알파 항체의 액상 제제

Publications (1)

Publication Number	Publication Date
KR20180106974A true KR20180106974A (ko)	2018-10-01

Family

ID=63522490

Family Applications (2)

Application Number	Title	Priority Date	Filing Date
KR1020180031016A Ceased KR20180106974A (ko)	2017-03-16	2018-03-16	항-tnf 알파 항체의 액상 제제
KR1020200098144A Active KR102342292B1 (ko)	2017-03-16	2020-08-05	항-tnf 알파 항체의 액상 제제

Family Applications After (1)

Application Number	Title	Priority Date	Filing Date
KR1020200098144A Active KR102342292B1 (ko)	2017-03-16	2020-08-05	항-tnf 알파 항체의 액상 제제

Country Status (14)

Country	Link
JP (2)	JP7109849B2 (fr)
KR (2)	KR20180106974A (fr)
CN (1)	CN110621303A (fr)
AU (1)	AU2018236651B2 (fr)
CO (1)	CO2019010860A2 (fr)
MA (1)	MA46988A1 (fr)
MX (1)	MX2019010895A (fr)
MY (1)	MY197202A (fr)
NZ (1)	NZ757965A (fr)
PH (1)	PH12019502075A1 (fr)
RU (1)	RU2756619C2 (fr)
UA (1)	UA123847C2 (fr)
WO (1)	WO2018169348A1 (fr)
ZA (1)	ZA201906696B (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
KR102735988B1 (ko) *	2019-02-18	2024-12-03	일라이 릴리 앤드 캄파니	치료 항체 제제
AU2020244106A1 (en) *	2019-03-18	2021-09-30	Alvotech Hf	Aqueous formulations of TNF-alpha antibodies in high concentrations
TWI861073B (zh) *	2019-03-21	2024-11-11	美商再生元醫藥公司	含有抗il-33抗體之穩定調配物
WO2021164717A1 (fr) *	2020-02-20	2021-08-26	百奥泰生物制药股份有限公司	PRÉPARATION D'ANTICORPS ANTI-TNF-α, SA MÉTHODE DE PRÉPARATION ET SON UTILISATION
JP2023533704A (ja) *	2020-07-13	2023-08-04	メルクパテントゲゼルシャフトミットベシュレンクテルハフツング	高濃度タンパク質製剤用の粘度低減賦形剤及びそれらの組み合わせ

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
JP5919606B2 (ja) *	2010-11-11	2016-05-18	アッヴィバイオテクノロジーリミテッド	改良型高濃度抗ｔｎｆアルファ抗体液体製剤
UY34105A (es) *	2011-06-03	2012-07-31	Lg Life Sciences Ltd	Formulación líquida estable de etanercept
MX363700B (es) *	2012-03-07	2019-03-29	Cadila Healthcare Ltd	Formulaciones farmaceuticas de anticuerpos tnf-alfa.
SG11201501715QA (en) *	2012-09-07	2015-05-28	Coherus Biosciences Inc	Stable aqueous formulations of adalimumab
JP2016505633A (ja)	2013-01-24	2016-02-25	グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッドＧｌａｘｏｓｍｉｔｈｋｌｉｎｅＩｎｔｅｌｌｅｃｔｕａｌＰｒｏｐｅｒｔｙＤｅｖｅｌｏｐｍｅｎｔＬｉｍｉｔｅｄ	ＴＮＦα抗原結合性タンパク質
CN105025925A (zh)	2013-03-15	2015-11-04	拜尔健康护理有限责任公司	抗-催乳素受体抗体制剂
WO2015134406A1 (fr)	2014-03-03	2015-09-11	La Jolla Biologics, Inc.	Préparations aqueuses stables de protéine recombinée
US10688187B2 (en)	2014-04-02	2020-06-23	Intas Pharmaceuticals Ltd.	Liquid pharmaceutical composition of adalimumab
LT2946765T (lt) *	2014-05-23	2016-11-25	Ares Trading S.A.	Skysta farmacinė kompozicija
US9821059B2 (en)	2014-10-17	2017-11-21	Alteogen Inc.	Composition for stabilizing protein and pharmaceutical formulation comprising the same
HUP1400510A1 (hu) *	2014-10-28	2016-05-30	Richter Gedeon Nyrt	Gyógyászati TNFalfa ellenes antitest készítmény
UY36542A (es) *	2015-01-28	2016-08-31	Mabxience S A	Formulaciones farmacéuticas para anticuerpos anti-tnf-alfa
WO2016162819A1 (fr) *	2015-04-07	2016-10-13	Lupin Limited	Composition pharmaceutique aqueuse stable d'anticorps anti-tnf alpha

2018
- 2018-03-16 KR KR1020180031016A patent/KR20180106974A/ko not_active Ceased
- 2018-03-16 MX MX2019010895A patent/MX2019010895A/es unknown
- 2018-03-16 AU AU2018236651A patent/AU2018236651B2/en active Active
- 2018-03-16 MA MA46988A patent/MA46988A1/fr unknown
- 2018-03-16 MY MYPI2019005331A patent/MY197202A/en unknown
- 2018-03-16 RU RU2019130728A patent/RU2756619C2/ru active
- 2018-03-16 WO PCT/KR2018/003097 patent/WO2018169348A1/fr not_active Ceased
- 2018-03-16 UA UAA201909838A patent/UA123847C2/uk unknown
- 2018-03-16 NZ NZ757965A patent/NZ757965A/en unknown
- 2018-03-16 CN CN201880031705.6A patent/CN110621303A/zh active Pending
- 2018-03-16 JP JP2019551275A patent/JP7109849B2/ja active Active
2019
- 2019-09-12 PH PH12019502075A patent/PH12019502075A1/en unknown
- 2019-09-30 CO CONC2019/0010860A patent/CO2019010860A2/es unknown
- 2019-10-10 ZA ZA2019/06696A patent/ZA201906696B/en unknown
2020
- 2020-08-05 KR KR1020200098144A patent/KR102342292B1/ko active Active
2022
- 2022-05-06 JP JP2022076654A patent/JP2022097600A/ja not_active Withdrawn

Also Published As

Publication number	Publication date
KR20200096472A (ko)	2020-08-12
KR102342292B1 (ko)	2021-12-24
CO2019010860A2 (es)	2020-01-17
RU2756619C2 (ru)	2021-10-04
RU2019130728A3 (fr)	2021-04-16
RU2019130728A (ru)	2021-04-16
PH12019502075A1 (en)	2020-09-14
WO2018169348A1 (fr)	2018-09-20
JP7109849B2 (ja)	2022-08-01
AU2018236651A1 (en)	2019-10-31
AU2018236651B2 (en)	2020-12-10
UA123847C2 (uk)	2021-06-09
NZ757965A (en)	2022-07-01
JP2020510079A (ja)	2020-04-02
MY197202A (en)	2023-05-31
BR112019019162A2 (pt)	2020-04-14
MA46988A1 (fr)	2020-06-30
CN110621303A (zh)	2019-12-27
MX2019010895A (es)	2019-11-05
ZA201906696B (en)	2020-08-26
JP2022097600A (ja)	2022-06-30

Publication	Publication Date	Title
KR102342292B1 (ko)	2021-12-24	항-tnf 알파 항체의 액상 제제
US12296007B2 (en)	2025-05-13	High concentration anti-blys pharmaceutical formulations
EP1712240B1 (fr)	2015-09-09	Preparation medicamenteuse aqueuse stable contenant un anticorps
AU2007338791B2 (en)	2014-03-13	Stable buffered formulations containing polypeptides
AU2007309616B2 (en)	2011-10-06	Stable polypeptide formulations
EP2081553B1 (fr)	2020-08-12	Formulations stables comprenant des anticorps
CA2976298A1 (fr)	2016-08-18	Formulation liquide stable pour des anticorps monoclonaux
JP7465814B2 (ja)	2024-04-11	高濃度タンパク質製剤の粘度低下
JP2025163108A (ja)	2025-10-28	抗ＩＬ－２３ｐ１９抗体製剤
AU2014201388B2 (en)	2016-05-12	Stable Buffered Formulations Containing Polypeptides
BR112019019162B1 (pt)	2024-10-22	Formulação líquida de um anticorpo anti-tnf-a e método parapreparar a formulação líquida
HK40005809B (en)	2021-11-12	Liquid pharmaceutical composition
KR20180046888A (ko)	2018-05-09	안정한 약제학적 제제

Legal Events

Date	Code	Title	Description
2018-03-16	A201	Request for examination
2018-03-16	PA0109	Patent application	Patent event code: PA01091R01D Comment text: Patent Application Patent event date: 20180316
2018-03-16	PA0201	Request for examination
2018-10-01	PG1501	Laying open of application
2019-04-12	E902	Notification of reason for refusal
2019-04-12	PE0902	Notice of grounds for rejection	Comment text: Notification of reason for refusal Patent event date: 20190412 Patent event code: PE09021S01D
2020-02-12	AMND	Amendment
2020-04-28	E601	Decision to refuse application
2020-04-28	PE0601	Decision on rejection of patent	Patent event date: 20200428 Comment text: Decision to Refuse Application Patent event code: PE06012S01D Patent event date: 20190412 Comment text: Notification of reason for refusal Patent event code: PE06011S01I
2020-06-03	AMND	Amendment
2020-06-03	PX0901	Re-examination	Patent event code: PX09011S01I Patent event date: 20200428 Comment text: Decision to Refuse Application Patent event code: PX09012R01I Patent event date: 20200212 Comment text: Amendment to Specification, etc.
2020-07-06	PX0601	Decision of rejection after re-examination	Comment text: Decision to Refuse Application Patent event code: PX06014S01D Patent event date: 20200706 Comment text: Amendment to Specification, etc. Patent event code: PX06012R01I Patent event date: 20200603 Comment text: Decision to Refuse Application Patent event code: PX06011S01I Patent event date: 20200428 Comment text: Amendment to Specification, etc. Patent event code: PX06012R01I Patent event date: 20200212 Comment text: Notification of reason for refusal Patent event code: PX06013S01I Patent event date: 20190412
2020-07-06	X601	Decision of rejection after re-examination
2020-08-05	A107	Divisional application of patent
2020-08-05	PA0107	Divisional application	Comment text: Divisional Application of Patent Patent event date: 20200805 Patent event code: PA01071R01D