Bora CDMO Bora CDMO

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For Filing In The U.S., Europe","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"INDIA","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"CSL Vifor","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tavneos\u00ae (avacopan) Approved In Australia For the Treatment Of ANCA-Associated Vasculitis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Genentech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"CSL Vifor","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tavneos\u00ae (avacopan) Included in Updated EULAR Recommendations for The Management Of AAV","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Roche\u2019s Polivy in Combination With R-CHP For People with Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Genmab","sponsor":"AbbVie Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genmab and AbbVie Announce Positive Topline Results from Phase 1\/2 EPCORE\u2122 NHL-1 Trial Evaluating Epcoritamab (DuoBody CD3xCD20) in Patients with Relapsed\/Refractory Follicular Lymphoma (FL)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"ADC Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ADC Therapeutics Announces Voluntary Pause of Enrollment in the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Dr. Reddy's Laboratories","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dr. Reddy\u2019s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"INDIA","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"ADC Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ADC Therapeutics Announces Plan to Discontinue the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Artiva Biotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Artiva Biotherapeutics Announces FDA Clearance of IND for AlloNK\u00ae Cell Therapy Candidate in Combination with Rituximab in Lupus Nephritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Immunology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Zenyaku Kogyo","sponsor":"Chugai Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Anti-CD20 Monoclonal Antibody Rituxan\u00ae Approved for Lupus Nephritis that has Not Responded Sufficiently to Existing Therapies","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Alentis Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alentis Therapeutics Doses First ANCA-Associated Vasculitis Rapidly Progressive Glomerulonephritis Patient in Phase 2 Clinical Trial of Lixudebart (ALE.F02)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Anti-CD20 Monoclonal Antibody Rituxan\u00ae Approved for Suppression and Treatment of Antibody-mediated Rejection in Organ Transplantation","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Artiva Biotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Artiva Biotherapeutics Receives FDA Fast Track Designation for AlloNK\u00ae in Lupus Nephritis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase I"},{"orgOrder":0,"company":"BioInvent","sponsor":"CASI Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CASI Pharmaceuticals Report Positive Interim Phase 1 Data For BI-1206 In The Treatment Of Relapsed\/Refractory Indolent Non-Hodgkin's Lymphoma In China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS\u00ae Regimen in Patients with Relapsed\/\u200bRefractory Diffuse Large B-cell Lymphoma (DLBCL)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"PolTREG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PolTREG Identifies Promising Efficacy Biomarker for Type-1 Diabetes in Patients Treated with its Treg Therapy in Combination with Rituximab","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"POLAND","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"ALX Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ALX Oncology Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1\/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (\u201cR\/R B-NHL\u201d)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]

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            Development Status

            Details:

            DRL_RI is being developed as a biosimilar of Rituxan/MabThera (rituximab), a CD20 directed cytolytic antibody for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, and pemphigus vulgaris.

            Lead Product(s): Rituximab

            Therapeutic Area: Immunology Product Name: DRL_RI

            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 July 12, 2023

            Details:

            DRL_RI is being developed as a biosimilar of rituximab, CD20 directed cytolytic antibody for various indications including treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, pemphigus vulgaris etc.

            Lead Product(s): Rituximab

            Therapeutic Area: Oncology 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 January 19, 2023

            Details:

            Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM.

            Lead Product(s): Ibrutinib,Rituximab

            Therapeutic Area: Oncology Product Name: Imbruvica

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 23, 2020

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            Phase 3 MURANO trial shows median progression-free survival of 53.6 months in previously treated CLL patients taking VENCLEXTA/VENCLYXTO in combination with rituximab Vs. 17.0 months in patients taking bendamustine plus rituximab after three years or more off treatment.

            Lead Product(s): Venetoclax,Rituximab

            Therapeutic Area: Oncology Product Name: Venclexta

            Highest Development Status: Phase III Product Type: Small molecule

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

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 05, 2020

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            Iran Expo

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            Details:

            Submission is based on results of more than five years of follow-up data from the Phase 3 iNNOVATE clinical trial evaluating IMBRUVICA in combination with rituximab for patients with WM. This is the longest follow-up data available for a BTK inhibitor in WM.

            Lead Product(s): Ibrutinib,Rituximab

            Therapeutic Area: Oncology Product Name: Imbruvica

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2020

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            Iran Expo

            Not Confirmed

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            Details:

            ALX Oncology lead product candidate ALX148 (evorpacept) in combination with Rituximab and Lenalidomide is being evaluated with patients for the treatment of patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

            Lead Product(s): Evorpacept,Rituximab,Lenalidomide

            Therapeutic Area: Oncology Product Name: ALX148

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 09, 2024

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            PTG-007, a treg cell therapy, in combination with rituximab, a CD20 inhibitor, is being investigated in a phase 1/2 trial for the treatment of type-1 diabetes.

            Lead Product(s): PTG-007,Rituximab

            Therapeutic Area: Endocrinology Product Name: PTG-007

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 04, 2024

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            Details:

            Pfizer's Adcetris (brentuximab vedotin), CD30 inhibitor, which is being evaluated in Phase III clinical trial studies in combination with Lenalidomide and Rituximab for the treatment of Relapsed/​Refractory Diffuse Large B-cell Lymphoma.

            Lead Product(s): Brentuximab Vedotin,Lenalidomide,Rituximab

            Therapeutic Area: Oncology Product Name: Adcetris

            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 March 12, 2024

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            Details:

            BI-1206 is a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB. It is being evaluated in combination with rituximab in patients with Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma.

            Lead Product(s): BI-1206,Rituximab

            Therapeutic Area: Oncology Product Name: BI-1206

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: CASI Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 05, 2024

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            AlloNK (AB-101) is an allogeneic NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies or NK cell engagers. in combination with rituximab or obinutuzumab for the treatment of lupus nephritis.

            Lead Product(s): AB-101,Rituximab,Cyclophosphamide

            Therapeutic Area: Nephrology Product Name: AlloNK

            Highest Development Status: Phase I Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2024

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