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[{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP Recommends EU Approval of Roche\u2019s Phesgo for HER2-Positive Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Organon","pharmaFlowCategory":"D","amount":"$103.0 million","upfrontCash":"$73.0 million","newsHeadline":"Organon Enters into Global License Agreement to Commercialize Henlius\u2019 Investigational Perjeta\u00ae (Pertuzumab) and Prolia\u00ae\/Xgeva\u00ae (Denosumab) Biosimilar Candidates","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Bolt Biotherapeutics","sponsor":"F. Hoffmann-La Roche","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Bolt Biotherapeutics Announces Positive Topline Data from BDC-1001 Phase 1 Dose-Escalation Trial in HER2-Expressing Tumors, Supporting Advancement to Phase 2 Clinical Studies","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chugai Obtains Regulatory Approval for Perjeta and Herceptin for Additional Indication of HER2-Positive Colorectal Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Roche Launches Antibody Drug for Breast Cancer in India","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Frontier Science Foundation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eight-year Data From APHINITY Study Show Roche's Perjeta-based Regimen Continues to Reduce the Risk of Disease Returning for People With HER2-positive Early Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chugai Files New Drug Application in Japan for Fixed-Dose Subcutaneous Combination of Pertuzumab and Trastuzumab for HER2-Positive Breast and Colorectal Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"EirGenix","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EirGenix's Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial Objectives","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chugai Obtains Regulatory Approval for Phesgo, the Fixed-Dose Subcutaneous Combination of Perjeta and Herceptin for HER2-Positive Breast and Colorectal Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Bolt Biotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bolt Biotherapeutics Enrolls First Patient in Phase 2 Clinical Study Evaluating BDC-1001 in Patients with HER2-Positive Breast Cancer Previously Treated with Enhertu\u00ae","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chugai Launches Phesgo Subcutaneous Combination for the Treatment of HER2-Positive Breast and Colorectal Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]

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            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 II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 05, 2023

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 22, 2023

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 25, 2023

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            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 I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 01, 2023

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            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 I Product Type: Large molecule

            Partner/Sponsor/Collaborator: F. Hoffmann-La Roche

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 29, 2023

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2022

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Frontier Science Foundation

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 14, 2022

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            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 III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Organon

            Deal Size: $103.0 million Upfront Cash: $73.0 million

            Deal Type: Licensing Agreement June 13, 2022

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 13, 2022

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 28, 2022

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