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Weekly News Recap #Phispers
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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...
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...
Details:
Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Chugai Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 12, 2023
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Chugai Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
New Data Reinforce the Benefit of Early Preventative Treatment With Genentech’s Hemlibra (emiciz...
Details : Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation functio...
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
September 12, 2023
Details:
Hemlibra (emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 02, 2023
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Chugai’s Hemlibra Approved by the European Commission to Treat People with Moderate Hemophilia A
Details : Hemlibra (emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation functio...
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
January 02, 2023
Details:
Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 02, 2023
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves Label Expansion of Roche’s Hemlibra to Include People with Moderate...
Details : Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation functio...
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
January 02, 2023
Details:
Hemlibra (emicizumab-kxwh), is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 16, 2022
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CHMP Recommends Expansion Of EU Label For Hemlibra To Include People With Moderate Haemophilia A
Details : Hemlibra (emicizumab-kxwh), is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with...
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
December 16, 2022
Details:
Hemlibra (emicizumab-kxwh) is bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 07, 2022
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Hemlibra (emicizumab-kxwh) is bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X.
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
December 07, 2022
Details:
Data show that Hemlibra (emicizumab-kxwh) maintained low treated bleed rates across study period, with 66.7% of participants experiencing no bleeds that required treatment, 81.9% experiencing no spontaneous bleeds that required treatment.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 07, 2022
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Data show that Hemlibra (emicizumab-kxwh) maintained low treated bleed rates across study period, with 66.7% of participants experiencing no bleeds that required treatment, 81.9% experiencing no spontaneous bleeds that required treatment.
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
November 07, 2022
Details:
Hemlibra (emicizumab-kxwh) continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild haemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 07, 2022
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Data From Phase III Haven 6 Study Reinforce Favourable Safety and Efficacy Profile of Roche’...
Details : Hemlibra (emicizumab-kxwh) continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild haemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up.
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
November 07, 2022
Details:
Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X. Hemlibra provides the cofactor function of factor VIII in people with hemophilia A.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 20, 2022
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Chugai Obtains Regulatory Approval for Hemlibra for Additional Indication of Acquired Hemophilia A
Details : Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X. Hemlibra provides the cofactor function of factor VIII in people w...
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
June 20, 2022
Details:
Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 13, 2021
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A.
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
December 13, 2021
Details:
The analysis did not show any new cases of thrombotic microangiopathy or serious thrombotic events (adverse events [AEs] that have been observed in people with bleeding disorders) related to Hemlibra.
Lead Product(s): Emicizumab
Therapeutic Area: Genetic Disease Brand Name: Hemlibra
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 19, 2021
Lead Product(s) : Emicizumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Data for Roche’s Hemlibra Reinforce Safety Profile in People with Haemophilia A
Details : The analysis did not show any new cases of thrombotic microangiopathy or serious thrombotic events (adverse events [AEs] that have been observed in people with bleeding disorders) related to Hemlibra.
Product Name : Hemlibra
Product Type : Antibody
Upfront Cash : Inapplicable
July 19, 2021
Regulatory Info :
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Inj Solution
Dosage Strength : 150mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Inj Solution
Dosage Strength : 30mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Inj Loose
Dosage Strength : 60mg/0.4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 30MG/1ML
Packaging : 1ML
Approval Date :
Application Number : 2479621
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 105MG/0.7ML
Packaging : 0.7ML
Approval Date :
Application Number : 2479656
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemlibra 105mg/0.7 ml
Dosage Form : INJ
Dosage Strength : 105mg
Packaging : 0.7X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemlibra 150mg/1 ml
Dosage Form : INJ
Dosage Strength : 150mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemlibra 30mg/1 ml
Dosage Form : INJ
Dosage Strength : 30mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : USA
Brand Name : HEMLIBRA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 30MG/ML
Packaging :
Approval Date :
Application Number : 761083
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : HEMLIBRA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 60MG/0.4ML
Packaging :
Approval Date :
Application Number : 761083
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Inj L?s
Dosage Strength : 105mg/0.7ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Inj Solution
Dosage Strength : 150mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Inj Solution
Dosage Strength : 30mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Inj Loose
Dosage Strength : 60mg/0.4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 30MG/1ML
Packaging : 1ML
Approval Date :
Application Number : 2479621
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 60MG/0.4ML
Packaging : 0.4ML
Approval Date :
Application Number : 2479648
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 105MG/0.7ML
Packaging : 0.7ML
Approval Date :
Application Number : 2479656
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 150MG/ML
Packaging :
Approval Date :
Application Number : 2479664
Regulatory Info : Prescription
Registration Country : Canada
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