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    [{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi Gets Priority FDA Review for Sutimlimab Product","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Results from Sanofi's Sutimlimab Pivotal Trial for People with Cold Agglutinin Disease Published in New England Journal of Medicine","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Sanofi","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Pivotal Data at EHA 2021 reinforces Sutimlimab as A First-in-Class Investigational C1s Inhibitor","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Enjaymo\u2122 (sutimlimab-jome), First Treatment for Use in Patients With Cold Agglutinin Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Media Update: CHMP Recommends Approval Of Enjaymo\u2122 (Sutimlimab), First And Only Approved Treatment For Hemolytic Anemia In Adult Patients With Cold Agglutinin Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP Recommends Approval Of Enjaymo\u2122 (Sutimlimab), First And Only Approved Treatment For Hemolytic Anemia In Adult Patients With Cold Agglutinin Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Enjaymo\u00ae (Sutimlimab) for Treatment of Hemolytic Anemia in Adult Patients With Cold Agglutinin Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"}]

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              Sanofi

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              European Commission Approves Enjaymo® (Sutimlimab) for Treatment of Hemolytic Anemia in Adult Patients With Cold Agglutinin Disease

              Details:

              Enjaymo (sutimlimab) is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system. Enjaymo inhibits the activation of the complement cascade in the immune system.

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: Enjaymo

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 17, 2022

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              Sanofi

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              Media Update: CHMP Recommends Approval Of Enjaymo™ (Sutimlimab), First And Only Approved Treatment For Hemolytic Anemia In Adult Patients With Cold Agglutinin Disease

              Details:

              Enjaymo (sutimlimab) is a humanized monoclonal antibody. By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in CAD to prevent the abnormal destruction of healthy RBCs.

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: Enjaymo

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 16, 2022

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              Sanofi

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              CHMP Recommends Approval Of Enjaymo™ (Sutimlimab), First And Only Approved Treatment For Hemolytic Anemia In Adult Patients With Cold Agglutinin Disease

              Details:

              Enjaymo™ (sutimlimab) is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system.

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: Enjaymo

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 16, 2022

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              Sanofi

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              Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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              FDA Approves Enjaymo™ (sutimlimab-jome), First Treatment for Use in Patients With Cold Agglutinin Disease

              Details:

              Enjaymo, selectively target and inhibit C1s is the only approved treatment to decrease the need for red blood cell transfusion due to hemolysis, the destruction of red blood cells, in adults with cold agglutinin disease.

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: Enjaymo

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 04, 2022

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              Sanofi

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              Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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              New Pivotal Data at EHA 2021 reinforces Sutimlimab as A First-in-Class Investigational C1s Inhibitor

              Details:

              The CADENZA trial is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of sutimlimab in patients with CAD without a recent history of blood transfusion (within the past 6 months).

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: BIVV009

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Sanofi

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 11, 2021

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              Sanofi

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              • Development Update
              Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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              Positive Results from Sanofi's Sutimlimab Pivotal Trial for People with Cold Agglutinin Disease Published in New England Journal of Medicine

              Details:

              Data from the pivotal Phase 3 CARDINAL study demonstrated sutimlimab inhibited C1-activated hemolysis (abnormal destruction of healthy red blood cells) within one week of treatment and had a sustained treatment effect over the course of the study.

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: BIVV009

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 07, 2021

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              Sanofi

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              Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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              FDA issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease

              Details:

              The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: BIVV009

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 14, 2020

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              India Med Expo

              Not Confirmed

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              Sanofi

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              Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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              Sanofi Gets Priority FDA Review for Sutimlimab Product

              Details:

              Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients.

              Lead Product(s): Sutimlimab

              Therapeutic Area: Immunology Product Name: Undisclosed

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 14, 2020

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              India Med Expo

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