[{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Reveals 1-year Data for Novel Subcutaneous Formulation of Infliximab in Crohn\u2019s disease and Ulcerative colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"February 2020","year":"2020","type":"Not Applicable","leadProduct":"Infliximab","moa":"TNF alpha","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III","graph3":"Celltrion","amount2":0,"therapeuticAreaNew":"Gastroenterology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Gastroenterology","productSubType":"","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"Celltrion \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celltrion \/ Not Applicable"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Healthcare Showcases Positive 1-Year Data and Budget Impact Analysis for Novel Subcutaneous Formulation of Infliximab for RA","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2020","year":"2020","type":"Not Applicable","leadProduct":"Infliximab","moa":"TNF alpha","url1":"","url2":"","graph1":"Immunology","graph2":"Approved","graph3":"Celltrion","amount2":0,"therapeuticAreaNew":"Immunology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Immunology","productSubType":"","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"Celltrion \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Celltrion \/ Not Applicable"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Healthcare Receives Positive CHMP Opinion for an Additional Five Indications for Remsima\u00ae SC","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2020","year":"2020","type":"Not Applicable","leadProduct":"Infliximab","moa":"TNF alpha","url1":"","url2":"","graph1":"Immunology","graph2":"Approved","graph3":"Celltrion","amount2":0,"therapeuticAreaNew":"Immunology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Immunology","productSubType":"","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"Celltrion \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Celltrion \/ Not Applicable"},{"orgOrder":0,"company":"National Institutes of Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NIH Begins Large Clinical Trial to Test Immune Modulators for Treatment of COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"","productType":"Large molecule","productStatus":"Approved","date":"October 2020","year":"2020","type":"Not Applicable","leadProduct":"Infliximab","moa":"TNF alpha","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III","graph3":"National Institutes of Health","amount2":0,"therapeuticAreaNew":"Infections and Infectious Diseases","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Infectious Diseases","productSubType":"","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"National Institutes of Health \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"National Institutes of Health \/ Not Applicable"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion Healthcare Receives Positive CHMP Opinion for Subcutaneous Formulation of Infliximab, Remsima\u00ae SC","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2021","year":"2021","type":"Not Applicable","leadProduct":"Infliximab","moa":"TNF 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2021","year":"2021","type":"Agreement","leadProduct":"Infliximab","moa":"TNF alpha","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase II\/ Phase III","graph3":"180 Life Sciences","amount2":0,"therapeuticAreaNew":"Musculoskeletal","highestDevelopmentStatusNew":"Phase II\/ Phase III","highestDevelopmentShortName":"Ph II\/III","therapeuticAreaShortName":"Musculoskeletal","productSubType":"","amount2New":0,"dosageForm":"","sponsorNew":"180 Life Sciences \/ Celltrion Healthcare","highestDevelopmentStatusID":"9","companyTruncated":"180 Life Sciences \/ Celltrion Healthcare"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"High Infliximab Trough Levels Are Associated With Low Risk of Relapse When Switching to Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease, Suggests New Data Presented at ECCO 2022 Virtual Congress","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2022","year":"2022","type":"Not Applicable","leadProduct":"Infliximab","moa":"TNF alpha","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved","graph3":"Celltrion","amount2":0,"therapeuticAreaNew":"Gastroenterology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gastroenterology","productSubType":"","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"Celltrion \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Celltrion \/ Not Applicable"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Show Statistically Greater Improvements in Clinical Outcomes with Subcutaneous Infliximab, 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Research"},{"orgOrder":0,"company":"Intract Pharma","sponsor":"SGS Life Sciences","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"SGS\u2019s Quay Pharma Collaborates to Develop New Oral Medicine for Inflammatory Bowel Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Preclinical","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"July 2022","year":"2022","type":"Collaboration","leadProduct":"Infliximab","moa":"","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Preclinical","graph3":"Intract Pharma","amount2":0,"therapeuticAreaNew":"Gastroenterology","highestDevelopmentStatusNew":"Preclinical","highestDevelopmentShortName":"Preclinical","therapeuticAreaShortName":"Gastroenterology","productSubType":"","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Intract Pharma \/ SGS Life Sciences","highestDevelopmentStatusID":"4","companyTruncated":"Intract Pharma \/ SGS Life Sciences"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion USA Announces Submission of the Biologics License Application (BLA) of Novel Subcutaneous Formulation of CT-P13 to U.S. Food and Drug Administration","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2022","year":"2022","type":"Not Applicable","leadProduct":"Infliximab","moa":"","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved","graph3":"Celltrion","amount2":0,"therapeuticAreaNew":"Gastroenterology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gastroenterology","productSubType":"","amount2New":0,"dosageForm":"Injectable\/Injection","sponsorNew":"Celltrion \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Celltrion \/ Not Applicable"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Health Canada Approves Remsima\u2122 SC for the Treatment of Inflammatory Bowel Disease (IBD)","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2024","year":"2024","type":"Not Applicable","leadProduct":"Infliximab","moa":"","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved","graph3":"Celltrion","amount2":0,"therapeuticAreaNew":"Gastroenterology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gastroenterology","productSubType":"","amount2New":0,"dosageForm":"Injection","sponsorNew":"Celltrion \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Celltrion \/ Not Applicable"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ZYMFENTRA\u2122 Shows Long-Term Efficacy for Crohn's Disease and Ulcerative Colitis Treatment","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"","productType":"Large molecule","productStatus":"Approved","date":"May 2024","year":"2024","type":"Not Applicable","leadProduct":"Infliximab","moa":"","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III","graph3":"Celltrion","amount2":0,"therapeuticAreaNew":"Gastroenterology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Gastroenterology","productSubType":"","amount2New":0,"dosageForm":"","sponsorNew":"Celltrion \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celltrion \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals for Inflectra

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                          01

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Zymfentra (infliximab) a TNF alpha inhibitor, is the first and only FDA-approved SC formulation, for adults with moderately to severely active ulcerative colitis and crohn’s disease.

                          Brand Name : Zymfentra

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          May 21, 2024

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Remsima (infliximab) blocks the action of TNF-alpha. It is approved for maintenance therapy in adults with moderately to severely active ulcerative colitis and crohn’s disease.

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          February 18, 2024

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          December 22, 2022

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Under a prior Memorandum of Understanding, the anti-TNF infliximab, Remsima (a biosimilar of Remicade), approved for use in the U.K., will be supplied for trial by Celltrion Healthcare UK Limited. The University of Oxford and Celltrion are currently comp...

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Undisclosed

                          July 27, 2022

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Neurology

                          Highest Development Status : Preclinical

                          Sponsor : National Institute for Health and Care Research

                          Deal Size : Undisclosed

                          Deal Type : Funding

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                          05

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Formulating infliximab as an oral capsule – which must survive the digestive system's harsh environment and reach the colon intact – is transformational.

                          Brand Name : Undisclosed

                          Molecule Type : Large molecule

                          Upfront Cash : Undisclosed

                          July 18, 2022

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : Preclinical

                          Sponsor : SGS Life Sciences

                          Deal Size : Undisclosed

                          Deal Type : Collaboration

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                          06

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Results Remsima (infliximab), showed a statistically significant difference in favour of SC compared to IV-treated patients at week 30 in almost all clinical variables, including low disease activity rates and remission rate.

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          June 01, 2022

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Immunology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Data from the RTDM study show infliximab drug levels are stable across a 14-day treatment cycle for Crohn’s disease patients in remission, under maintenance therapy with Remsima SC, enabling therapeutic drug monitoring to be performed at any time betwe...

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          February 18, 2022

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Under the MOU with Celltrion Healthcare, supply of anti-TNF biosimilar drug used in the ongoing development for new indications including the first antibody biosimilar, Remsima®, infliximab for major autoimmune disorders such as rheumatoid arthritis and...

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Undisclosed

                          September 20, 2021

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : Phase II/ Phase III

                          Sponsor : Celltrion

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          09

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Remsima™ SC is the first and only subcutaneous form of infliximab to patients, payers and clinicians in Canada. Remsima™ SC offers an innovative treatment option for patients living with chronic inflammatory conditions in Canada.

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          June 07, 2021

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Immunology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : The recommended new posology is to start Remsima® SC 120mg weekly up to week 4 and inject every 2 weeks thereafter; For patients currently on infliximab IV, Remsima® SC can be administered after 8 weeks from last dose without additional IV loading.

                          Brand Name : Remsima

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          March 31, 2021

                          Lead Product(s) : Infliximab

                          Therapeutic Area : Immunology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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