WO2020191270A1 - Stabilized formulations containing anti-il-33 antibodies - Google Patents
Stabilized formulations containing anti-il-33 antibodies Download PDFInfo
- Publication number
- WO2020191270A1 WO2020191270A1 PCT/US2020/023795 US2020023795W WO2020191270A1 WO 2020191270 A1 WO2020191270 A1 WO 2020191270A1 US 2020023795 W US2020023795 W US 2020023795W WO 2020191270 A1 WO2020191270 A1 WO 2020191270A1
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- WO
- WIPO (PCT)
- Prior art keywords
- pharmaceutical formulation
- stable liquid
- antibody
- liquid pharmaceutical
- formulation
- Prior art date
- 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
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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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Definitions
- Interleukin-33 is a ligand for ST2, a toll-like/interleukin-1 receptor super-family member that associates with an accessory protein, IL-1 RAcP (for reviews, see, e.g., Kakkar and Lee, Nature Reviews - Drug Discovery 7(10): 827-840 (2008), Schmitz et al. , Immunity 23:479-490 (2005); Liew et al., Nature Reviews - Immunology 70:103-110 (2010); US 2010/0260770; US 2009/0041718).
- the stable liquid pharmaceutical formulation comprises: (i) about 15 mg/ml ⁇ 1.5 mg/ml of the antibody; (ii) about 10 mM ⁇ 2 mM acetate; (iii) about 70 mM ⁇ 14 mM arginine hydrochloride (iv) about 5% w/v ⁇ 1% w/v sucrose; and (iv) about 0.08% ⁇ 0.016% w/v polysorbate 80.
- the formulation comprises no more than 0.7% HMW species after 12 months of storage at 2-8°C, as determined by SE-UPLC.
- the stable liquid pharmaceutical formulation comprises no more than 2% HMW species after 18 months of storage at 2-8°C, as determined by SE-UPLC.
- the formulation comprises no more than 1% HMW species after 18 months of storage at 2-8°C, as determined by SE-UPLC.
- the formulation comprises no more than 0.7% HMW species after 18 months of storage at 2-8°C, as determined by SE-UPLC.
- the labeling recites subcutaneous administration of the pharmaceutical formulation. In some embodiments, the labeling recites intravenous administration of the pharmaceutical formulation.
- antibody is generally intended to refer to immunoglobulin molecules comprising four polypeptide chains, two heavy (H) chains and two light (L) chains inter connected by disulfide bonds, as well as multimers thereof (e.g., IgM); however, immunoglobulin molecules consisting of only heavy chains (i.e., lacking light chains) are also encompassed within the definition of the term "antibody.”
- Each heavy chain comprises a heavy chain variable region (abbreviated herein as HCVR or VH) and a heavy chain constant region.
- the heavy chain constant region comprises three domains, CH1 , CH2 and CH3.
- the antibodies of the invention may, in some embodiments, be recombinant human antibodies.
- the term "recombinant human antibody,” as used herein, is intended to include all human antibodies that are prepared, expressed, created or isolated by recombinant means, such as antibodies expressed using a recombinant expression vector transfected into a host cell, antibodies isolated from a recombinant, combinatorial human antibody library, antibodies isolated from an animal (e.g., a mouse) that is transgenic for human immunoglobulin genes (see e.g., Taylor et al. (1992) Nucl. Acids Res.
- the pharmaceutical formulations contain from 15 ⁇ 0.15 mg/ml to 150 ⁇ 1.5 mg/ml of the anti-IL-33 antibody. In some cases, the pharmaceutical formulations contain 75 mg/mL ⁇ 3.75 mg/mL of the anti-IL-33 antibody. In some cases, the pharmaceutical
- two antibodies are bioequivalent if there are no clinically meaningful differences in their safety, purity, and potency.
- two antibodies are bioequivalent if a patient can be switched one or more times between the reference product and the biological product without an expected increase in the risk of adverse effects, including a clinically significant change in immunogenicity, or diminished effectiveness, as compared to continued therapy without such switching.
- the pharmaceutical formulations of the present invention may comprise about 0.5%; about 1.0%; about 1.5%; about 2.0%; about 2.5%; about 3.0%; about 3.5%; about 4.0%; about 4.5%; about 5.0%; about 5.5%; about 6.0%; about 6.5%; about 7.0%; about 7.5%; about 8.0%; about 8.5%; about 9.0%; about 9.5%; about 10.0%; about 15%; or about 20% sugar (e.g., sucrose).
- sugar e.g., sucrose
- the formulations contain about 5% sugar (e.g., sucrose).
- the stable liquid pharmaceutical formulation comprises (i) a human antibody that specifically binds to hlL-33 (e.g ., mAb1) at a concentration of from about 1 mg/ml to about 200 mg/ml; (ii) a buffer (e.g., acetate) at a concentration of from about 1 mM to about 20 mM; (iii) an amino acid (e.g., arginine) at a concentration of from about 30 mM to about 110 mM; (iv) a thermal stabilizer (e.g., sucrose) at a concentration of from about 1 % w/v to about 10% w/v; and (v) an organic cosolvent (e.g., polysorbate 80) at a concentration of from about 0.01 % w/v to about 0.15% w/v.
- a human antibody that specifically binds to hlL-33 e.g ., mAb1
- a buffer e.g.,
- the stable liquid pharmaceutical formulation comprises (i) a human antibody that specifically binds to hlL-33 (e.g., mAb1) at a concentration of from about 15 mg/ml to about 150 mg/ml; (ii) a buffer (e.g., acetate) at a concentration of from about 5 mM to about 15 mM; (iii) an amino acid (e.g., arginine) at a concentration of from about 50 mM to about 90 mM; (iv) a thermal stabilizer (e.g., sucrose) at a concentration of from about 3% w/v to about 7% w/v; and (v) an organic cosolvent (e.g., polysorbate 80) at a concentration of from about 0.05% w/v to about 0.11 % w/v.
- a human antibody that specifically binds to hlL-33 e.g., mAb1
- a buffer e.g., acetate
- the stable liquid pharmaceutical formulation comprises (i) a human antibody that specifically binds to hlL-33 and comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 18 and a light chain comprising the amino acid sequence of SEQ ID NO: 20 at a concentration of from about 15 mg/ml to about 150 mg/ml; (ii) acetate at a concentration of about 10 mM; (iii) arginine (e.g., arginine hydrochloride) at a concentration of about 70 mM; (iv) sucrose at a concentration of about 5% w/v; and (v) polysorbate 80 at a concentration of about 0.08% w/v.
- a human antibody that specifically binds to hlL-33 and comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 18 and a light chain comprising the amino acid sequence of SEQ ID NO: 20 at a concentration of from about 15 mg/ml to about 150 mg/ml; (ii
- a pharmaceutical formulation may also be deemed stable if after three months of storage at -20°C, -30°C, or -80°C less than about 2%, 1.9%, 1.8%, 1.7%, 1.6%, 1.5%, 1 %, 0.5%, or 0.1 % of the antibody is detected in an aggregated form.
- a low level of viscosity in reference to a fluid formulation of the present invention, will exhibit an absolute viscosity of less than about 20 cPoise (cP) at 20°C.
- a fluid formulation of the invention will be deemed to have "low viscosity,” if, when measured using standard viscosity measurement techniques, the formulation exhibits an absolute viscosity of about 19 cP, about 18 cP, about 17 cP, about 16 cP, about 15 cP, about 14 cP, about 13 cP, about 12 cP, about 11 cP, about 10 cP, about 9 cP, about 8 cP, about 7 cP, about 6 cP, about 5 cP, about 4 cP, or less.
- the rubber plungers used in syringes, and the rubber stoppers used to close the openings of vials may be coated to prevent contamination of the medicinal contents of the syringe or vial and/or to preserve their stability.
- pharmaceutical formulations of the present invention may be contained within a syringe that comprises a coated plunger, or within a vial that is sealed with a coated rubber stopper.
- the plunger or stopper may be coated with a fluorocarbon film. Examples of coated stoppers and/or plungers suitable for use with vials and syringes containing the pharmaceutical formulations of the present invention are mentioned in, e.g., U.S. Patent Nos.
- the present invention also includes methods of preparing a unit dosage form.
- a method for preparing a pharmaceutical unit dosage form includes combining the formulation of any of foregoing embodiments in a suitable container ⁇ e.g., those containers discussed herein).
- CEX Cation exchange
- DS Drug substance
- HMW High molecular weight
- iCIEF Imaging capillary isoelectric focusing
- LMW Low molecular weight
- MCE-SDS Microchip capillary electrophoresis-sodium dodecyl sulfate
- NR Not required
- OD Optical density
- RH Relative humidity
- RP Reverse phase
- Table 25 Research Stability of 150 mg/mL mAb1 Drug Product in glass vials Stored at Accelerated and Stress Conditions, and against Agitation
- CEX Cation exchange
- DS Drug substance
- FDG Formulation Development group
- HMW High molecular weight
- iCIEF Imaged capillary isoelectric focusing
- LMW Low molecular weight
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Environmental & Geological Engineering (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Priority Applications (17)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20718107.4A EP3941522A1 (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-il-33 antibodies |
| BR112021018727A BR112021018727A2 (pt) | 2019-03-21 | 2020-03-20 | Formulações estabilizadas que contêm anticorpos anti il 33 |
| MX2021011137A MX2021011137A (es) | 2019-03-21 | 2020-03-20 | Formulaciones estabilizadas que contienen anticuerpos anti-il-33. |
| SG11202109822X SG11202109822XA (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-il-33 antibodies |
| AU2020241882A AU2020241882A1 (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-iL-33 antibodies |
| PH1/2021/552092A PH12021552092A1 (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-il-33 antibodies |
| IL317899A IL317899A (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-IL–33 antibodies |
| KR1020217033469A KR20210141592A (ko) | 2019-03-21 | 2020-03-20 | 항-il-33 항체를 함유하는 안정화된 제형 |
| CN202411908169.7A CN119700966A (zh) | 2019-03-21 | 2020-03-20 | 含有抗il-33抗体的稳定调配物 |
| IL286024A IL286024B2 (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-IL–33 antibodies |
| CN202411908014.3A CN119700965A (zh) | 2019-03-21 | 2020-03-20 | 含有抗il-33抗体的稳定调配物 |
| JP2021556435A JP7695887B2 (ja) | 2019-03-21 | 2020-03-20 | 抗il-33抗体を含有する安定化製剤 |
| EA202192568A EA202192568A1 (ru) | 2019-03-21 | 2020-03-20 | Стабилизированные составы, содержащие антитела к il-33 |
| CN202080021576.XA CN113573733B (zh) | 2019-03-21 | 2020-03-20 | 含有抗il-33抗体的稳定调配物 |
| CA3133995A CA3133995A1 (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-il-33 antibodies |
| CONC2021/0011648A CO2021011648A2 (es) | 2019-03-21 | 2021-09-02 | Formulaciones estabilizadas que contienen anticuerpos anti-il-33 |
| JP2025094518A JP2025131756A (ja) | 2019-03-21 | 2025-06-06 | 抗il-33抗体を含有する安定化製剤 |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962821661P | 2019-03-21 | 2019-03-21 | |
| US62/821,661 | 2019-03-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2020191270A1 true WO2020191270A1 (en) | 2020-09-24 |
Family
ID=70228884
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2020/023795 Ceased WO2020191270A1 (en) | 2019-03-21 | 2020-03-20 | Stabilized formulations containing anti-il-33 antibodies |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US11596690B2 (https=) |
| EP (1) | EP3941522A1 (https=) |
| JP (2) | JP7695887B2 (https=) |
| KR (1) | KR20210141592A (https=) |
| CN (3) | CN119700966A (https=) |
| AU (1) | AU2020241882A1 (https=) |
| BR (1) | BR112021018727A2 (https=) |
| CA (1) | CA3133995A1 (https=) |
| CL (1) | CL2021002440A1 (https=) |
| CO (1) | CO2021011648A2 (https=) |
| EA (1) | EA202192568A1 (https=) |
| IL (2) | IL286024B2 (https=) |
| MA (1) | MA55362A (https=) |
| MX (1) | MX2021011137A (https=) |
| PH (1) | PH12021552092A1 (https=) |
| SA (1) | SA521430229B1 (https=) |
| SG (1) | SG11202109822XA (https=) |
| TW (2) | TW202519263A (https=) |
| WO (1) | WO2020191270A1 (https=) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4149521A1 (en) * | 2020-05-11 | 2023-03-22 | MedImmune Limited | Formulations of anti-il-33 antibodies |
| US12351626B2 (en) | 2021-09-03 | 2025-07-08 | Qyuns Therapeutics Co., Ltd. | Anti-human interleukin-33 monoclonal antibody and use thereof |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| CN113842457B (zh) * | 2021-11-04 | 2022-05-20 | 江苏荃信生物医药股份有限公司 | 包含抗人白介素-33单克隆抗体的液体制剂 |
| WO2023077685A1 (zh) * | 2021-11-04 | 2023-05-11 | 江苏荃信生物医药股份有限公司 | 包含抗人白介素-33单克隆抗体的浓缩溶液的制备方法及液体制剂 |
| WO2026067832A1 (zh) * | 2024-09-30 | 2026-04-02 | 深圳市小分子新药创新中心有限公司 | 抗il-33单域抗体及其衍生物 |
Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4997423A (en) | 1986-10-15 | 1991-03-05 | Daikyo Gomu Seiko Ltd. | Laminated sliding stopper for a syringe |
| US5908686A (en) | 1992-01-23 | 1999-06-01 | Daikyo Gomu Seiko, Ltd | Modified polysiloxane composition and a sanitary rubber article coated with the composition |
| US6286699B1 (en) | 1995-04-05 | 2001-09-11 | Daikyo Seiko, Ltd. | Laminated rubber stopper |
| US6645635B2 (en) | 2001-01-19 | 2003-11-11 | Daikyo Seiko, Ltd. | Laminated rubber stopper for a medicament vial |
| US7226554B2 (en) | 1999-01-29 | 2007-06-05 | Daikyo Seiko, Ltd. | Molding die assembly for rubber members and rubber member produced thereby |
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| US12351626B2 (en) | 2021-09-03 | 2025-07-08 | Qyuns Therapeutics Co., Ltd. | Anti-human interleukin-33 monoclonal antibody and use thereof |
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| TWI861073B (zh) | 2024-11-11 |
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| MX2021011137A (es) | 2021-10-22 |
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| US20230346929A1 (en) | 2023-11-02 |
| PH12021552092A1 (en) | 2022-05-30 |
| CN113573733A (zh) | 2021-10-29 |
| EP3941522A1 (en) | 2022-01-26 |
| KR20210141592A (ko) | 2021-11-23 |
| CL2021002440A1 (es) | 2022-04-22 |
| IL286024A (en) | 2021-10-31 |
| US11596690B2 (en) | 2023-03-07 |
| MA55362A (fr) | 2022-01-26 |
| CN119700965A (zh) | 2025-03-28 |
| CO2021011648A2 (es) | 2021-09-30 |
| JP2022526292A (ja) | 2022-05-24 |
| CN119700966A (zh) | 2025-03-28 |
| BR112021018727A2 (pt) | 2022-02-15 |
| SA521430229B1 (ar) | 2024-01-23 |
| CA3133995A1 (en) | 2020-09-24 |
| JP2025131756A (ja) | 2025-09-09 |
| TW202102260A (zh) | 2021-01-16 |
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