API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
Details:
BDC-1001 is an investigational immune-stimulating antibody conjugate (ISAC), which is being developed for the treatment of patients with HER2-Positive Breast Cancer.
Lead Product(s): BDC-1001,Pertuzumab
Therapeutic Area: Oncology Product Name: BDC-1001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2023
Details:
Phesgo (pertuzumab and trastuzumab) is the HER2 humanized monoclonal antibody, which is indicated for the treatment of HER2-positive breast cancer and Advanced or recurrent HER2-positive colorectal cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Vorhyaluronidase Alfa
Therapeutic Area: Oncology Product Name: Phesgo
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 22, 2023
Details:
Phesgo (pertuzumab and trastuzumab) is the HER2 humanized monoclonal antibody, which is indicated for the treatment of HER2-positive breast cancer and Advanced or recurrent HER2-positive colorectal cancer.
Lead Product(s): Pertuzumab,Trastuzumab
Therapeutic Area: Oncology Product Name: Phesgo
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 25, 2023
Details:
EG1206A (pertuzumab) targets the extracellular dimerization domain (Subdomain II) of the HER2 and, thereby, blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3 and HER4.
Lead Product(s): Pertuzumab
Therapeutic Area: Oncology Product Name: EG1206A
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2023
Details:
Under the agreement, Roche will provide pertuzumab in support of a Phase 2 metastatic breast cancer trial to evaluate pertuzumab in combination with BDC-1001.
Lead Product(s): BDC-1001,Pertuzumab
Therapeutic Area: Oncology Product Name: BDC-1001
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 29, 2023
Details:
NDA for fixed-dose subcutaneous combination of RG6264 (pertuzumab) and trastuzumab (same monoclonal antibodies as in perjeta and herceptin), based on data including results from global phase III FeDeriCa study in patients with HER2-positive breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab
Therapeutic Area: Oncology Product Name: HLX11
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 September 29, 2022
Details:
Results at 8.4 years median follow-up showed benefit of combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (Perjeta-based regimen), versus Herceptin, chemotherapy and placebo, given as post-surgery IV treatment for people with lymph node-positive.
Lead Product(s): Pertuzumab,Trastuzumab,Carboplatin
Therapeutic Area: Oncology Product Name: Perjeta
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Frontier Science Foundation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
The agreement includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy ® (ipilimumab, HLX13), Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).
Lead Product(s): Pertuzumab,Trastuzumab
Therapeutic Area: Oncology Product Name: HLX11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Organon
Deal Size: $103.0 million Upfront Cash: $73.0 million
Deal Type: Licensing Agreement June 13, 2022
Details:
Phesgo (pertuzumab) is the world's first fixed dose combination of two monoclonal antibodies Perjeta (pertuzumab) and Herceptin (trastuzumab) in Oncology for the treatment of HER - 2 positive breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Hyaluronidase
Therapeutic Area: Oncology Product Name: Phesgo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2022
Details:
Combination therapy of Perjeta and Herceptin obtained regulatory approval for advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy.
Lead Product(s): Pertuzumab
Therapeutic Area: Oncology Product Name: Perjeta
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
Phesgo offers faster and less invasive delivery of standard of care treatment with Perjeta and Herceptin, under the skin in just minutes, compared to hours with intravenous infusion.
Lead Product(s): Pertuzumab,Trastuzumab,Hyaluronidase
Therapeutic Area: Oncology Product Name: Phesgo
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 13, 2020