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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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FDF
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API SUPPLIERS
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
Registration Number : 221MF10097
Registrant's Address : 101 International Drive Pease International Trade Port Portsmouth New Hampshire 03801 USA
Initial Date of Registration : 2009-05-21
Latest Date of Registration :
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Listed Suppliers
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Epysqli
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Teva Pharmaceutical Industries
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 07, 2025
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva and Samsung Bioepis Launch EPYSQLI in the U.S.
Details : Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Product Name : Epysqli
Product Type : Antibody
Upfront Cash : Inapplicable
April 07, 2025
Details:
Soliris (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Soliris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 17, 2025
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CDSCO Approves AstraZeneca’s Anti-Complement Medicine Eculizumab
Details : Soliris (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Product Name : Soliris
Product Type : Antibody
Upfront Cash : Inapplicable
January 17, 2025
Details:
Under the licensing agreement, Teva will be responsible for the commercialization of the product in the U.S. It is being indicated for the treatment of paroxysmal nocturnal hemoglobinuria.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Epysqli
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Teva Pharmaceutical Industries
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 10, 2025
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Samsung Bioepis, Teva Partner to Commercialize EPYSQLI® in US
Details : Under the licensing agreement, Teva will be responsible for the commercialization of the product in the U.S. It is being indicated for the treatment of paroxysmal nocturnal hemoglobinuria.
Product Name : Epysqli
Product Type : Antibody
Upfront Cash : Undisclosed
January 10, 2025
Details:
Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Epysqli
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2024
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Samsung Bioepis’ EPYSQLI® as Biosimilar to Soliris
Details : Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Product Name : Epysqli
Product Type : Antibody
Upfront Cash : Inapplicable
July 22, 2024
Details:
Bkemv (eculizumab) is approved by FDA as the first interchangeable biosimilar to Soliris to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Bkemv
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 28, 2024
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
Details : Bkemv (eculizumab) is approved by FDA as the first interchangeable biosimilar to Soliris to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Product Name : Bkemv
Product Type : Antibody
Upfront Cash : Inapplicable
May 28, 2024
Details:
Danicopan is an investigational oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who experience clinically significant extravascular haemolysis.
Lead Product(s): Danicopan,Eculizumab,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 12, 2023
Lead Product(s) : Danicopan,Eculizumab,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Danicopan is an investigational oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who experience clinically significant extravascular haemolysis.
Product Name : Voydeya
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 12, 2023
Details:
Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in Japan for the treatment of adults with Neuromyelitis Optica Spectrum Disorder.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Soliris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2023
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in Japan for the treatment of adults with Neuromyelitis Optica Spectrum Disorder.
Product Name : Soliris
Product Type : Antibody
Upfront Cash : Inapplicable
October 18, 2023
Details:
ALXN2040 (danicopan) is an investigational oral medicine in development as an add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) for patients with PNH who experience clinically significant EVH.
Lead Product(s): Danicopan,Eculizumab,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Voydeya
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Alexion Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 06, 2023
Lead Product(s) : Danicopan,Eculizumab,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Alexion Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ALXN2040 (danicopan) is an investigational oral medicine in development as an add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) for patients with PNH who experience clinically significant EVH.
Product Name : Voydeya
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 06, 2023
Details:
Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in Japan for the treatment of adults with refractory generalised myasthenia gravis.
Lead Product(s): Eculizumab
Therapeutic Area: Immunology Brand Name: Soliris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2023
Lead Product(s) : Eculizumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Soliris Approved in Japan for Paediatric Patients with Generalised Myasthenia Gravis (gMG)
Details : Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in Japan for the treatment of adults with refractory generalised myasthenia gravis.
Product Name : Soliris
Product Type : Antibody
Upfront Cash : Inapplicable
August 24, 2023
Details:
Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in China for the treatment of adults with refractory generalised myasthenia gravis.
Lead Product(s): Eculizumab
Therapeutic Area: Immunology Brand Name: Soliris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2023
Lead Product(s) : Eculizumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in China for the treatment of adults with refractory generalised myasthenia gravis.
Product Name : Soliris
Product Type : Antibody
Upfront Cash : Inapplicable
July 27, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info :
Registration Country : USA
Brand Name : SOLIRIS
Dosage Form : INJECTABLE; IV (INFUSION)
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 125166
Regulatory Info :
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SOLIRIS
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 30ML
Approval Date :
Application Number : 2322285
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
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Packaging : 1
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Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
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Packaging : 1
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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