AU2013342321B2 - Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment - Google Patents

Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment Download PDF

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Publication number
AU2013342321B2
AU2013342321B2 AU2013342321A AU2013342321A AU2013342321B2 AU 2013342321 B2 AU2013342321 B2 AU 2013342321B2 AU 2013342321 A AU2013342321 A AU 2013342321A AU 2013342321 A AU2013342321 A AU 2013342321A AU 2013342321 B2 AU2013342321 B2 AU 2013342321B2
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Australia
Prior art keywords
long
liquid formulation
oxyntomodulin derivative
lasting
lasting oxyntomodulin
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AU2013342321A
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AU2013342321A1 (en
Inventor
Sung Min Bae
Myung Hyun Jang
Hyun Uk Kim
Sang Yun Kim
Se Chang Kwon
Hyung Kyu Lim
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Hanmi Pharmaceutical Co Ltd
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Hanmi Pharmaceutical Co Ltd
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Publication of AU2013342321A1 publication Critical patent/AU2013342321A1/en
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Priority to AU2017279583A priority Critical patent/AU2017279583B2/en
Priority to AU2020200626A priority patent/AU2020200626B2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/605Glucagons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Cell Biology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Mycology (AREA)
  • Emergency Medicine (AREA)
  • Microbiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
AU2013342321A 2012-11-06 2013-11-06 Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment Active AU2013342321B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2017279583A AU2017279583B2 (en) 2012-11-06 2017-12-18 Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment
AU2020200626A AU2020200626B2 (en) 2012-11-06 2020-01-29 Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20120124725 2012-11-06
KR10-2012-0124725 2012-11-06
PCT/KR2013/009986 WO2014073842A1 (en) 2012-11-06 2013-11-06 Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment

Related Child Applications (1)

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AU2017279583A Division AU2017279583B2 (en) 2012-11-06 2017-12-18 Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment

Publications (2)

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AU2013342321A1 AU2013342321A1 (en) 2015-05-28
AU2013342321B2 true AU2013342321B2 (en) 2017-09-28

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AU2013342321A Active AU2013342321B2 (en) 2012-11-06 2013-11-06 Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment
AU2017279583A Active AU2017279583B2 (en) 2012-11-06 2017-12-18 Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment
AU2020200626A Active AU2020200626B2 (en) 2012-11-06 2020-01-29 Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment

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AU2017279583A Active AU2017279583B2 (en) 2012-11-06 2017-12-18 Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment
AU2020200626A Active AU2020200626B2 (en) 2012-11-06 2020-01-29 Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment

Country Status (26)

Country Link
US (3) US9724420B2 (https=)
EP (2) EP3610856B1 (https=)
JP (2) JP6363612B2 (https=)
KR (2) KR102311517B1 (https=)
CN (1) CN104884045B (https=)
AR (2) AR093387A1 (https=)
AU (3) AU2013342321B2 (https=)
BR (1) BR112015010235B1 (https=)
CA (1) CA2890324C (https=)
CL (1) CL2015001206A1 (https=)
DK (1) DK2916819T3 (https=)
EA (3) EA034499B1 (https=)
ES (1) ES2748158T3 (https=)
IL (2) IL238626B (https=)
MX (2) MX372833B (https=)
MY (2) MY197849A (https=)
NZ (3) NZ708103A (https=)
PE (1) PE20151421A1 (https=)
PH (2) PH12018501454A1 (https=)
PL (1) PL2916819T3 (https=)
PT (1) PT2916819T (https=)
SG (2) SG11201503370WA (https=)
TW (3) TWI602583B (https=)
UA (2) UA116364C2 (https=)
WO (1) WO2014073842A1 (https=)
ZA (1) ZA201503998B (https=)

Families Citing this family (41)

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UA126465C2 (uk) 2011-06-10 2022-10-12 ะฅะฐะฝะผั– ะกะฐะนะตะฝั ะšะพ., ะ›ั‚ะด. ะŸะตะฟั‚ะธะด, ั‰ะพ ะผะฐั” ะฐะบั‚ะธะฒะฝั–ัั‚ัŒ ะพะบัะธะฝั‚ะพะผะพะดัƒะปั–ะฝัƒ, ั‚ะฐ ั„ะฐั€ะผะฐั†ะตะฒั‚ะธั‡ะฝะฐ ะบะพะผะฟะพะทะธั†ั–ั ะดะปั ะปั–ะบัƒะฒะฐะฝะฝั ะพะถะธั€ั–ะฝะฝั, ัะบะฐ ะนะพะณะพ ะผั–ัั‚ะธั‚ัŒ
RU2607365C2 (ru) 2011-06-17 2017-01-10 ะฅะฐะฝะผะธ ะกะฐะนะตะฝั ะšะพ., ะ›ั‚ะด. ะšะพะฝัŠัŽะณะฐั‚, ัะพะดะตั€ะถะฐั‰ะธะน ะพะบัะธะฝั‚ะพะผะพะดัƒะปะธะฝ ะธ ั„ั€ะฐะณะผะตะฝั‚ ะธะผะผัƒะฝะพะณะปะพะฑัƒะปะธะฝะฐ, ะธ ะตะณะพ ะฟั€ะธะผะตะฝะตะฝะธะต
KR20130049671A (ko) 2011-11-04 2013-05-14 ํ•œ๋ฏธ์‚ฌ์ด์–ธ์Šค ์ฃผ์‹ํšŒ์‚ฌ ์ƒ๋ฆฌํ™œ์„ฑ ํด๋ฆฌํŽฉํƒ€์ด๋“œ ๊ฒฐํ•ฉ์ฒด ์ œ์กฐ ๋ฐฉ๋ฒ•
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
KR101968344B1 (ko) * 2012-07-25 2019-04-12 ํ•œ๋ฏธ์•ฝํ’ˆ ์ฃผ์‹ํšŒ์‚ฌ ์˜ฅ์‹ ํ† ๋ชจ๋“ˆ๋ฆฐ ์œ ๋„์ฒด๋ฅผ ํฌํ•จํ•˜๋Š” ๊ณ ์ง€ํ˜ˆ์ฆ ์น˜๋ฃŒ์šฉ ์กฐ์„ฑ๋ฌผ
UA116217C2 (uk) 2012-10-09 2018-02-26 ะกะฐะฝะพั„ั– ะŸะตะฟั‚ะธะดะฝะฐ ัะฟะพะปัƒะบะฐ ัะบ ะฟะพะดะฒั–ะนะฝะธะน ะฐะณะพะฝั–ัั‚ ั€ะตั†ะตะฟั‚ะพั€ั–ะฒ glp1-1 ั‚ะฐ ะณะปัŽะบะฐะณะพะฝัƒ
WO2014073842A1 (en) 2012-11-06 2014-05-15 Hanmi Pharm. Co., Ltd. Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment
KR101993393B1 (ko) * 2012-11-06 2019-10-01 ํ•œ๋ฏธ์•ฝํ’ˆ ์ฃผ์‹ํšŒ์‚ฌ ์˜ฅ์‹ ํ† ๋ชจ๋“ˆ๋ฆฐ ์œ ๋„์ฒด๋ฅผ ํฌํ•จํ•˜๋Š” ๋‹น๋‡จ๋ณ‘ ๋˜๋Š” ๋น„๋งŒ์„ฑ ๋‹น๋‡จ๋ณ‘ ์น˜๋ฃŒ์šฉ ์กฐ์„ฑ๋ฌผ
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