Seqens Seqens

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[{"orgOrder":0,"company":"BeiGene","sponsor":"Amgen Inc","pharmaFlowCategory":"D","amount":"$2,800.0 million","upfrontCash":"$2,800.0 million","newsHeadline":"Amgen Commences Strategic Collaboration With BeiGene to Expand Oncology Presence in China","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Eden Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Subjects Dosed in JHL's Phase I Clinical Study of a Denosumab Biosimilar","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"BeiGene","sponsor":"Amgen Inc","pharmaFlowCategory":"D","amount":"$421.0 million","upfrontCash":"Undisclosed","newsHeadline":"Amgen Doubles Down on BeiGene Collaboration, Investing $421M More","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Shanghai Henlius Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Shanghai Henlius Biotech First Patient Dosed in Phase 1 Clinical Trial of Henlius Denosumab Biosimilar HLX14","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Initiates Phase 1 Clinical Trial for SB16, Proposed Biosimilar to Prolia (Denosumab)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"BeiGene","sponsor":"Amgen Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BeiGene Announces the Approval of XGEVA\u00ae in China for the Prevention of Skeletal-Related Events in Patients With Bone Metastases From Solid Tumors and in Patients With Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Initiates Phase 3 Clinical Trial for SB16, Proposed Biosimilar to Prolia (Denosumab)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Luye Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Luye Pharma Starts a Phase III Clinical Study for Denosumab Injection (LY01011) in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Gedeon Richter","sponsor":"Hikma Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Richter and Hikma Sign Exclusive Commercialisation and License Agreement for Denosumab in the US, a Proposed Biosimilar Referencing Prolia\u00ae and Xgeva\u00ae","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"HUNGARY","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2021","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Lupin Ltd","sponsor":"DKSH","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Lupin and DKSH Sign an Exclusive Licensing and Supply Agreement to Market Five Biosimilar Candidates in the Philippines","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"INDIA","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Redx Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Redx Announces First Patient Dosed in Phase 2 Clinical Trial of RXC004 in Patients with Advanced Colorectal Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Mabxience","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Amneal Adds Two Denosumab Biosimilars to U.S. Pipeline, Expanding Oncology Portfolio","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"SPAIN","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2023","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Initiates a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia and Xgeva","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Eden Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Subjects Dosed in Australian Phase I Clinical Study of a Denosumab Biosimilar","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"Eden Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eden Biologics\u2019 Leading Biosimilar Program Receives Phase 3 Approval in Europe","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2021","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Initiates Confirmatory Patient Study for AVT03, a Proposed Biosimilar for Prolia\u00ae and Xgeva\u00ae","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Sandoz B2B","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Announces Further Progress on its Biosimilar Pipeline, With Release of Positive Results For Denosumab Integrated Phase I\/III Clinical Trial","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Sandoz B2B","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Biologics License Application For Proposed Biosimilar Denosumab Accepted By US FDA","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2023","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Mabwell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The World's Second Approved Biosimilars of Denosumab (MAILISHU)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2023","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"},{"orgOrder":0,"company":"Sandoz B2B","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Marketing Authorization Applications For Proposed Biosimilar Denosumab Accepted By EMA","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2023","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Alvotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia and Xgeva","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"ICELAND","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2024","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"Mabwell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mabwell Publishes the Phase III Study Results on Its Denosumab Biosimilar (MW032) in the Journal JAMA Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Amgen Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"UK MHRA Approves New Formulation of Amgen\u2019s XGEVA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Sandoz B2B","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Mabwell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"April 2024","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"}]

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            Maiweijian (denosumab) is a fully human recombinant anti-RANKL monoclonal antibody, which is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: Maiweijian

            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 April 08, 2024

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            Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.

            Lead Product(s): Denosumab

            Therapeutic Area: Oncology Product Name: Wyost

            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 05, 2024

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            Xgeva (denosumab) is a human monoclonal antibody and a RANK ligand inhibitor. Its new formulation is indicated for the treatment of patients with bone metastases.

            Lead Product(s): Denosumab

            Therapeutic Area: Oncology Product Name: Xgeva

            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 01, 2024

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            MW032 (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia. It is a RANK ligand inhibitor, which is being evaluated for treament of bone metastases from solid tumors.

            Lead Product(s): Denosumab

            Therapeutic Area: Oncology Product Name: MW032

            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 February 21, 2024

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            AVT03 (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is being evaluated in phase 1 trials for bone loss in adult men.

            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: AVT03

            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 January 29, 2024

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            Under the terms of agreement, mAbxience will fully develop the biosimilar, Denosumab (ref Prolia and XGEVA) and manufacture in it's GMP-approved facilities, while Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the US.

            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: MB-09

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Amneal Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition October 12, 2023

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            Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss.

            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: GP2411

            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 May 25, 2023

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            Mailishu (denosumab) is a human monoclonal antibody designed to bind and inhibit RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.

            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: Mailishu

            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 April 03, 2023

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            Denosumab is a human monoclonal antibody designed to bind and inhibit RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.

            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            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 February 06, 2023

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            Denosumab (GP2411) is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss.

            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: GP2411

            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 19, 2022

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