X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
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: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2020
RDD 2024
Not Confirmed
Contact SupplierDetails:
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
RDD 2024
Not Confirmed
Contact Supplier
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
