HRP20201392T1 - Fgf21 fuzijski proteini dugotrajnog djelovanja i farmaceutski pripravci koji sadrže iste - Google Patents
Fgf21 fuzijski proteini dugotrajnog djelovanja i farmaceutski pripravci koji sadrže iste Download PDFInfo
- Publication number
- HRP20201392T1 HRP20201392T1 HRP20201392TT HRP20201392T HRP20201392T1 HR P20201392 T1 HRP20201392 T1 HR P20201392T1 HR P20201392T T HRP20201392T T HR P20201392TT HR P20201392 T HRP20201392 T HR P20201392T HR P20201392 T1 HRP20201392 T1 HR P20201392T1
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- Prior art keywords
- amino acid
- fusion protein
- seq
- terminal end
- protein
- Prior art date
Links
- 102000003973 Fibroblast growth factor 21 Human genes 0.000 title claims 17
- 108090000376 Fibroblast growth factor 21 Proteins 0.000 title claims 17
- 102000037865 fusion proteins Human genes 0.000 title claims 15
- 108020001507 fusion proteins Proteins 0.000 title claims 15
- 239000008194 pharmaceutical composition Substances 0.000 title claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 12
- 238000006467 substitution reaction Methods 0.000 claims 6
- 230000035772 mutation Effects 0.000 claims 5
- 108060003951 Immunoglobulin Proteins 0.000 claims 4
- 150000001413 amino acids Chemical group 0.000 claims 4
- 102000018358 immunoglobulin Human genes 0.000 claims 4
- 125000000539 amino acid group Chemical group 0.000 claims 2
- 239000013604 expression vector Substances 0.000 claims 2
- 208000008338 non-alcoholic fatty liver disease Diseases 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 150000007523 nucleic acids Chemical class 0.000 claims 2
- 208000032928 Dyslipidaemia Diseases 0.000 claims 1
- 208000017170 Lipid metabolism disease Diseases 0.000 claims 1
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 1
- 208000008589 Obesity Diseases 0.000 claims 1
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 1
- 210000004899 c-terminal region Anatomy 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 206010053219 non-alcoholic steatohepatitis Diseases 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1825—Fibroblast growth factor [FGF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/475—Growth factors; Growth regulators
- C07K14/50—Fibroblast growth factor [FGF]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Diabetes (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Toxicology (AREA)
- Child & Adolescent Psychology (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (15)
1. Fuzijski protein koji sadrži mutirani protein fibroblastnog faktora rasta 21 (FGF21) i Fc regiju imunoglobulina,
pri čemu mutirani protein FGF21 sadrži slijedeću mutaciju:
(1) supstituciju aminokiselina na položajima 98 do 101 od N-terminalnog kraja proteina divljeg tipa FGF21 s aminokiselinskom sekvencom EIRP (SEQ ID NO: 42).
2. Fuzijski protein prema zahtjevu 1, naznačen time što mutirani protein FGF21 nadalje sadrži slijedeću mutaciju:
(6) supstituciju aminokiseline na položaju 180 od N-terminalnog kraja proteina divljeg tipa FGF21 s aminokiselinom E.
3. Fuzijski protein prema zahtjevu 1 ili zahtjevu 2, naznačen time što mutirani protein FGF21 nadalje sadrži najmanje jednu mutaciju odabranu iz skupine koja se sastoji od slijedećih mutacija:
(2) supstitucije aminokiselina na položajima 170 do 174 od N-terminalnog kraja proteina divljeg tipa FGF21 s aminokiselinskom sekvencom TGLEAV (SEQ ID NO: 43);
(3) supstitucije aminokiselina na položajima 170 do 174 od N-terminalnog kraja proteina divljeg tipa FGF21 s aminokiselinskom sekvencom TGLEAN (SEQ ID NO: 44);
(4) supstitucije aminokiseline na položaju 170 od N-terminalnog kraja proteina divljeg tipa FGF21 s aminokiselinom N; i
(5) supstitucije aminokiseline na položaju 174 od N-terminalnog kraja proteina divljeg tipa FGF21 s aminokiselinom N.
4. Fuzijski protein prema bilo kojem od zahtjeva 1 do 3, naznačen time što je aminokiselinski ostatak N mutiranog proteina FGF21 uveden mutacijom glikoziliran.
5. Fuzijski protein prema bilo kojem od zahtjeva 1 do 4, naznačen time što protein divljeg tipa FGF21 ima aminokiselinsku sekvencu predstavljenu SEQ ID NO: 1.
6. Fuzijski protein prema bilo kojem od zahtjeva 1, 4 i 5, naznačen time što mutirani protein FGF21 ima aminokiselinsku sekvencu predstavljenu bilo kojim od SEQ ID NO: 6, 11 do 15 i 20 do 23.
7. Fuzijski protein prema bilo kojem od zahtjeva 1 do 6, naznačen time što je mutirani protein FGF21 povezan s Fc regijom imunoglobulina preko veznika.
8. Fuzijski protein prema zahtjevu 7, naznačen time što je veznik povezan sa C-terminalnim krajem Fc regije imunoglobulina i N- terminalnim krajem mutiranog proteina FGF21, poželjno gdje je veznik peptid koji se sastoji od 10 do 30 aminokiselinskih ostataka, nadalje poželjno gdje veznik ima aminokiselinsku sekvencu predstavljenu bilo kojim od SEQ ID NO: 2 do 5.
9. Fuzijski protein prema bilo kojem od zahtjeva 1 do 8, naznačen time što je Fc regija imunoglobulina bilo koja od Fc regija IgGl, IgG2, IgG3, IgG4 i IgD, ili hibridni Fc koji sadrži njihovu kombinaciju.
10. Fuzijski protein prema zahtjevu 9, naznačen time što hibridni Fc sadrži IgG4 regiju i IgD regiju.
11. Fuzijski protein prema bilo kojem od zahtjeva 1 do 10, naznačen time što fuzijski protein ima aminokiselinsku sekvencu predstavljenu SEQ ID NO: 36, SEQ ID NO: 37 ili SEQ ID NO: 39.
12. Farmaceutski pripravak koji sadrži fuzijski protein prema bilo kojem od zahtjeva 1 do 11 za liječenje dijabetesa, pretilosti, dislipidemije, metaboličkog sindroma, bezalkoholne bolesti masne jetre ili bezalkoholnog steatohepatitisa.
13. Izolirana molekula nukleinske kiseline koja kodira fuzijski protein prema bilo kojem od zahtjeva 1 do 11.
14. Vektor ekspresije sadrži molekulu nukleinske kiseline prema zahtjevu 13.
15. Stanica domaćina koja sadrži ekspresijski vektor prema zahtjevu 14.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020150150574A KR102668200B1 (ko) | 2015-10-28 | 지속형 fgf21 융합 단백질 및 이를 포함하는 약학적 조성물 | |
PCT/KR2016/012288 WO2017074117A1 (en) | 2015-10-28 | 2016-10-28 | Long-acting fgf21 fusion proteins and pharmaceutical composition comprising same |
EP16860300.9A EP3368554B1 (en) | 2015-10-28 | 2016-10-28 | Long-acting fgf21 fusion proteins and pharmaceutical composition comprising same |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20201392T1 true HRP20201392T1 (hr) | 2020-11-27 |
Family
ID=58630685
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20201392TT HRP20201392T1 (hr) | 2015-10-28 | 2020-09-01 | Fgf21 fuzijski proteini dugotrajnog djelovanja i farmaceutski pripravci koji sadrže iste |
Country Status (21)
Country | Link |
---|---|
US (2) | US11142557B2 (hr) |
EP (2) | EP3744731A1 (hr) |
JP (2) | JP7303629B2 (hr) |
CN (1) | CN108290937B (hr) |
AU (2) | AU2016346864B2 (hr) |
BR (1) | BR112018008676A2 (hr) |
CA (1) | CA3003109A1 (hr) |
CY (1) | CY1123307T1 (hr) |
DK (1) | DK3368554T3 (hr) |
ES (1) | ES2815540T3 (hr) |
HK (1) | HK1257375A1 (hr) |
HR (1) | HRP20201392T1 (hr) |
HU (1) | HUE051036T2 (hr) |
LT (1) | LT3368554T (hr) |
MX (1) | MX2018005194A (hr) |
PT (1) | PT3368554T (hr) |
RS (1) | RS60725B1 (hr) |
RU (1) | RU2741087C2 (hr) |
SI (1) | SI3368554T1 (hr) |
WO (1) | WO2017074117A1 (hr) |
ZA (1) | ZA201802002B (hr) |
Families Citing this family (17)
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AU2016346870B2 (en) | 2015-10-28 | 2021-04-22 | Yuhan Corporation | Dual function proteins and pharmaceutical composition comprising same |
LT3368554T (lt) | 2015-10-28 | 2020-09-25 | Yuhan Corporation | Ilgo veikimo fgf21 sulieti baltymai ir juos apimanti farmacinė kompozicija |
BR112019009581A2 (pt) * | 2016-11-10 | 2019-10-08 | Yuhan Corp | composição farmacêutica para evitar ou tratar hepatite, fibrose hepática, e cirrose hepática que compreende proteínas de fusão |
EA201992516A1 (ru) * | 2017-04-21 | 2020-04-09 | Юхан Корпорейшн | Способ получения бифункциональных белков и их производных |
MX2020002206A (es) * | 2017-09-08 | 2020-07-20 | Bristol Myers Squibb Co | Factor de crecimiento de fibroblastos 21 (fgf-21) modificado para usarse en metodos para tratar la esteatohepatitis no alcoholica (nash). |
JP2021528422A (ja) * | 2018-06-21 | 2021-10-21 | サノフイSanofi | 最適化された活性比を有するfgf21化合物/glp−1rアゴニストの組合せ |
CN108635571B (zh) * | 2018-07-19 | 2021-10-22 | 西安交通大学医学院第一附属医院 | 鸢尾素(irisin)在制备预防及治疗重症急性胰腺炎药物中的应用 |
CN111195234B (zh) * | 2018-11-16 | 2022-08-26 | 鲁南制药集团股份有限公司 | 一种重组FGF21-Fc融合蛋白冻干粉制剂 |
CN109836486B (zh) * | 2019-01-30 | 2020-09-08 | 北京双因生物科技有限公司 | 成纤维生长因子21变体、其融合蛋白及其用途 |
US20220064244A1 (en) * | 2019-03-05 | 2022-03-03 | Sunshine Lake Pharma Co., Ltd. | A polypeptide molecule and application thereof |
TW202337914A (zh) * | 2019-04-23 | 2023-10-01 | 南韓商Lg化學股份有限公司 | 融合多肽及其用途與製備方法、核酸分子、重組載體、重組細胞以及用於增強生長/分化因子15或其功能變體的活體內穩定性的方法 |
US20230090114A1 (en) * | 2020-01-31 | 2023-03-23 | 89Bio Ltd. | Methods for promoting weight loss |
EP4308610A1 (en) * | 2021-03-19 | 2024-01-24 | Sunshine Lake Pharma Co., Ltd. | Uses of fgf21 polypeptides and fusion polypeptides thereof |
CN113198002A (zh) * | 2021-05-12 | 2021-08-03 | 上海交通大学医学院附属第九人民医院 | 一种用于治疗非酒精性脂肪肝的肝细胞因子bmp9 |
CN117677640A (zh) * | 2021-07-05 | 2024-03-08 | 上海翰森生物医药科技有限公司 | 一种融合蛋白及其医药用途 |
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WO2023245543A1 (en) * | 2022-06-23 | 2023-12-28 | Ampsource Biopharma Shanghai Inc. | Uses of fgf21 fusion proteins |
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AU2016346870B2 (en) * | 2015-10-28 | 2021-04-22 | Yuhan Corporation | Dual function proteins and pharmaceutical composition comprising same |
LT3368554T (lt) | 2015-10-28 | 2020-09-25 | Yuhan Corporation | Ilgo veikimo fgf21 sulieti baltymai ir juos apimanti farmacinė kompozicija |
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BR112019009581A2 (pt) * | 2016-11-10 | 2019-10-08 | Yuhan Corp | composição farmacêutica para evitar ou tratar hepatite, fibrose hepática, e cirrose hepática que compreende proteínas de fusão |
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EA201992516A1 (ru) | 2017-04-21 | 2020-04-09 | Юхан Корпорейшн | Способ получения бифункциональных белков и их производных |
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2016
- 2016-10-28 LT LTEP16860300.9T patent/LT3368554T/lt unknown
- 2016-10-28 DK DK16860300.9T patent/DK3368554T3/da active
- 2016-10-28 PT PT168603009T patent/PT3368554T/pt unknown
- 2016-10-28 HU HUE16860300A patent/HUE051036T2/hu unknown
- 2016-10-28 US US15/768,616 patent/US11142557B2/en active Active
- 2016-10-28 EP EP20179208.2A patent/EP3744731A1/en active Pending
- 2016-10-28 AU AU2016346864A patent/AU2016346864B2/en active Active
- 2016-10-28 RS RS20201024A patent/RS60725B1/sr unknown
- 2016-10-28 CN CN201680062639.XA patent/CN108290937B/zh active Active
- 2016-10-28 MX MX2018005194A patent/MX2018005194A/es unknown
- 2016-10-28 RU RU2018119141A patent/RU2741087C2/ru active
- 2016-10-28 SI SI201630903T patent/SI3368554T1/sl unknown
- 2016-10-28 JP JP2018521995A patent/JP7303629B2/ja active Active
- 2016-10-28 WO PCT/KR2016/012288 patent/WO2017074117A1/en active Application Filing
- 2016-10-28 EP EP16860300.9A patent/EP3368554B1/en active Active
- 2016-10-28 ES ES16860300T patent/ES2815540T3/es active Active
- 2016-10-28 BR BR112018008676-2A patent/BR112018008676A2/pt active Search and Examination
- 2016-10-28 CA CA3003109A patent/CA3003109A1/en active Pending
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2018
- 2018-03-26 ZA ZA2018/02002A patent/ZA201802002B/en unknown
- 2018-12-26 HK HK18116583.9A patent/HK1257375A1/zh unknown
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2020
- 2020-08-26 CY CY20201100796T patent/CY1123307T1/el unknown
- 2020-09-01 HR HRP20201392TT patent/HRP20201392T1/hr unknown
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2021
- 2021-06-18 AU AU2021204115A patent/AU2021204115A1/en active Pending
- 2021-08-04 JP JP2021128120A patent/JP7453943B2/ja active Active
- 2021-09-17 US US17/478,600 patent/US20220002367A1/en not_active Abandoned
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