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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: ApprovedProduct 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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EMWA 2024

Not Confirmed

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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 IIIProduct 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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EMWA 2024

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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: ApprovedProduct 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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EMWA 2024

Not Confirmed

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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 IIIProduct 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 IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 19, 2023

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 IIProduct 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 IIProduct 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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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 IIIProduct 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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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 IIProduct 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 IProduct 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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Rituxan (rituximab) is an anti-CD20 monoclonal antibody, which is now approved for the treatment of suppression and treatment of antibody-mediated rejection in organ transplantation.


Lead Product(s): Rituximab

Therapeutic Area: Immunology Product Name: Rituxan

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 22, 2023

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ALE.F02 (Lixudebart Rituximab GlucoCorticoid) is a claudin 1 inhibitor antibody drug candidate, which is currently being evaluated for the treatment of antineutrophil cytoplasmic antibody-associated vasculitis with rapidly progressive glomerulonephritis.


Lead Product(s): Lixudebart,Rituximab,GlucoCorticoid

Therapeutic Area: Immunology Product Name: ALE.F02

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

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Rituxan (rituximab) is an anti-CD20 monoclonal antibody that specifically binds to CD20, a protein expressed on B cells, excluding hematopoietic stem cells and plasma cells, which is used for the treatment of Lupus Nephritis.


Lead Product(s): Rituximab

Therapeutic Area: Nephrology Product Name: Rituxan

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Chugai Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 23, 2023

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AlloNK (AB-101) is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with Combination with Rituximab in Lupus Nephritis.


Lead Product(s): AB-101,Rituximab

Therapeutic Area: Immunology Product Name: AlloNK

Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 16, 2023

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ADC Therapeutics' CD19-specific Antibody Drug Conjugate (ADC), Zynlonta (loncastuximab tesirine-lpyl) is FDA-approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more systemic therapies.


Lead Product(s): Loncastuximab Tesirine,Rituximab

Therapeutic Area: Oncology Product Name: Zynlonta

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 July 20, 2023

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Zynlonta (loncastuximab tesirine-lpyl), an antibody-drug conjugate (ADC) targeting CD19, is being developed in combination with rituximab in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).


Lead Product(s): Loncastuximab Tesirine,Rituximab

Therapeutic Area: Oncology Product Name: Zynlonta

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 July 11, 2023

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GEN3013 (epcoritamab-bysp) is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells, which is used for Diffuse Large B-cell Lymphoma.


Lead Product(s): Epcoritamab-bysp,Rituximab,Lenalidomide

Therapeutic Area: Oncology Product Name: GEN3013

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: AbbVie Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 27, 2023

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Polivy® (polatuzumab vedotin-piiq) is a first-in-class anti-CD79b antibody-drug conjugate (ADC). It binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells.


Lead Product(s): Polatuzumab Vedotin-piiq,Rituximab,Cyclophosphamide

Therapeutic Area: Oncology Product Name: Polivy

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 19, 2023

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Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a, blocking neutrophil activation and migration. Currently being developed for the treatment of ANCA-associated vasculitis.


Lead Product(s): Avacopan,Rituximab

Therapeutic Area: Rare Diseases and Disorders Product Name: Tavneos

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 28, 2023

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Polivy® (polatuzumab vedotin-piiq) is a first-in-class anti-CD79b antibody-drug conjugate (ADC). It binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells.


Lead Product(s): Polatuzumab Vedotin,Rituximab,Cyclophosphamide

Therapeutic Area: Oncology Product Name: Polivy

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 09, 2023

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Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a, blocking neutrophil activation and migration. Currently being developed for the treatment of ANCA-associated vasculitis.


Lead Product(s): Avacopan,Rituximab

Therapeutic Area: Immunology Product Name: Tavneos

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 07, 2023

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Pirtobrutinib (LOXO-305), is an investigational, highly selective, reversible (non-covalent) inhibitor of Bruton's tyrosine kinase (BTK). Pirtobrutinib was developed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate.


Lead Product(s): Pirtobrutinib,Venetoclax,Rituximab

Therapeutic Area: Oncology Product Name: LOXO-305

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 12, 2022

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The acquisition includes TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor that was approved by the U.S. FDA in October 2021 as an adjunctive therapy for adults with severe active ANCA-associated vasculitis.


Lead Product(s): Avacopan,Rituximab

Therapeutic Area: Immunology Product Name: Tavneos

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Amgen Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition October 20, 2022

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CYT-0851 is in a Phase 1/2 clinical trial as both a monotherapy and in combination with standard of care chemotherapy and has the potential to be a first-in-class MCT inhibitor. By impairing monocarboxylate transporter-mediated lactate transport, CYT-0851 disrupts glycolysis.


Lead Product(s): Rad51-IN-2,Rituximab,Bendamustine Hydrochloride

Therapeutic Area: Oncology Product Name: CYT-0851

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 12, 2022

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AB-101, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva is currently advancing a Phase 1/2 of AB-101 in combination with rituximab for the treatment of relapsed or refractory B-cell lymphomas.


Lead Product(s): AB-101,Rituximab,Interleukin 2

Therapeutic Area: Oncology Product Name: AB-101

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 05, 2022

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ZYNLONTA® (loncastuximab tesirine-lpyl) is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.


Lead Product(s): Loncastuximab Tesirine,Rituximab

Therapeutic Area: Oncology Product Name: Zynlonta

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 21, 2022

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The opinion is based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory DLBCL following two or more prior lines of systemic therapy.


Lead Product(s): Loncastuximab Tesirine,Rituximab

Therapeutic Area: Oncology Product Name: Zynlonta

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 16, 2022

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BI-1206, a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB, in combination with rituximab in patients with relapsed/refractory Non-Hodgkin's Lymphoma (NHL).


Lead Product(s): BI1206,Rituximab

Therapeutic Area: Oncology Product Name: BI1206

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: BioInvent

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2022

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TAVNEOS® (avacopan) is indicated as adjunctive treatment of adult patients with severe active ANCA-associated vasculitis (granulomatosis with polyangiitis) and microscopic polyangiitis [MPA] in combination with standard therapy including glucocorticoids.


Lead Product(s): Avacopan,Rituximab

Therapeutic Area: Immunology Product Name: Tavneos

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2022

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Polivy® intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL).


Lead Product(s): Polatuzumab Vedotin,Rituximab,Cyclophosphamide

Therapeutic Area: Oncology Product Name: Polivy

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2022

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Tavneos® (avacopan) is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1,reduces the ability of those cells to do damage in response to C5a activation.


Lead Product(s): Avacopan,Rituximab,Cyclophosphamide

Therapeutic Area: Immunology Product Name: Tavneos

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Amgen Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 18, 2022

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Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).


Lead Product(s): Polatuzumab Vedotin,Rituximab,Cyclophosphamide

Therapeutic Area: Oncology Product Name: Polivy

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 16, 2022

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mAbxience has developed and manufactured biological drugs, with commercialized biosimilar product Novex® (rituximab), through its in-house biosimilars programs and through its investment in mAbxience, Fresenius expects rapid growth in biopharmaceutical market.


Lead Product(s): Rituximab

Therapeutic Area: Oncology Product Name: Novex

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Fresenius Kabi AG

Deal Size: $553.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition August 01, 2022

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ZYNLONTA® (loncastuximab tesirine-lpyl), is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.


Lead Product(s): Loncastuximab Tesirine,Rituximab

Therapeutic Area: Oncology Product Name: Zynlonta

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 July 20, 2022

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ME-401 (zandelisib), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, potential therapeutic option for patients with B-cell malignancies.


Lead Product(s): Zandelisib,Rituximab

Therapeutic Area: Oncology Product Name: ME-401

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Kyowa Kirin

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 18, 2022

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EO2463 is an innovative, off-the-shelf microbiome-peptide based cancer vaccine that combines four microbiome-peptides of B lymphocyte-specific lineage markers.


Lead Product(s): EO2463,Rituximab,Lenalidomide

Therapeutic Area: Oncology Product Name: EO2463

Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 12, 2022

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ZYNLONTA® (loncastuximab tesirine-lpyl) is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.


Lead Product(s): Loncastuximab Tesirine,Rituximab

Therapeutic Area: Oncology Product Name: Zynlonta

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Overland Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 11, 2022

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Rituxan (rituximab) is an anti-CD20 monoclonal antibody that specifically binds to CD20, a protein expressed on B cells, excluding stem cells and plasma cells. It attacks target B cells using the immune system equipped with the human body, and damages cells.


Lead Product(s): Rituximab

Therapeutic Area: Rare Diseases and Disorders Product Name: Rituxan

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Chugai Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 20, 2022

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ME-401 (zandelisib), an orally administered investigational phosphatidylinositol 3- kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies


Lead Product(s): Zandelisib,Rituximab

Therapeutic Area: Oncology Product Name: ME-401

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Kyowa Kirin

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 10, 2022

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RIABNI (rituximab-arrx), a biosimilar to Rituxan, CD20-directed cytolytic antibody, was proven to be highly similar to, with no clinically meaningful differences in safety or efficacy from, based on totality of evidence.


Lead Product(s): Rituximab

Therapeutic Area: Immunology Product Name: Riabni

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 06, 2022

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Data for CYT-0851 show that the drug has performed well in cancer patients: it has desirable pharmacologic properties with an estimated half-life of three days, dose proportional exposure, and a dose dependent, predictable, and favorable safety profile.


Lead Product(s): Rad51-IN-2,Rituximab,Bendamustine Hydrochloride

Therapeutic Area: Oncology Product Name: CYT-0851

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2022

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A phase 2 study evaluated the efficacy of Debio 1562 (naratuximab emtansine), an anti-CD37 ADC, in combination with rituximab, in patients with R/R DLBCL. Deep learning models were used to extract spatial features from digitized slides stained with CD37 and CD20.


Lead Product(s): Naratuximab Emtansine,Rituximab

Therapeutic Area: Oncology Product Name: Debio 1562

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 June 04, 2022

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Clinical trials are investigating the efficacy and safety of ME-401 (zandelisib) as a single agent and in combination with other modalities while administered on an Intermittent Dosing Regimen (ID) and in a time-limited manner when dosed in combination.


Lead Product(s): Zandelisib,Rituximab

Therapeutic Area: Oncology Product Name: ME-401

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Kyowa Kirin

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 04, 2022

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With a median follow-up of 84.7 months, the IMBRUVICA (Ibrutinib) plus BR and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3-year improvement in median PFS.


Lead Product(s): Ibrutinib,Bendamustine Hydrochloride,Rituximab

Therapeutic Area: Oncology Product Name: Imbruvica

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 03, 2022

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Treatment with Tazverik (tazemetostat) and R2 was generally well tolerated and the adverse events were consistent with those contained in the prescribing information for both tazemetostat and R2, respectively.


Lead Product(s): Tazemetostat,Rituximab,Lenalidomide

Therapeutic Area: Oncology Product Name: Tazverik

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2022

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TAVNEOS® (avacopan), an orally administered selective complement 5a receptor inhibitor, and have potential application in C3 glomerulopathy, as well as the immuno-oncology potential of CCX559, an orally administered small molecule PD-L1 inhibitor.


Lead Product(s): Avacopan,Rituximab

Therapeutic Area: Immunology Product Name: Tavneos

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 31, 2022

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Approval is based on pivotal data from the phase III POLARIX study, where Polivy (Polatuzumab Vedotin) plus R-CHP significantly improved progression-free survival with comparable safety versus the standard of care, R-CHOP.


Lead Product(s): Polatuzumab Vedotin,Rituximab,Cyclophosphamide

Therapeutic Area: Oncology Product Name: Polivy

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 25, 2022

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XPOVIO® (selinexor) is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).


Lead Product(s): Selinexor,Lenalidomide,Rituximab

Therapeutic Area: Oncology Product Name: Xpovio

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 23, 2022

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Zynlonta (loncastuximab tesirine-lpyl), is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.


Lead Product(s): Loncastuximab Tesirine,Rituximab

Therapeutic Area: Oncology Product Name: Zynlonta

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 May 12, 2022

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Clinical and preclinical data suggest that ME-401 (zandelisib) distinct characteristics include prolonged target binding, preferential cellular accumulation, high volume of distribution throughout body tissues, and an approx, 28-hour half-life suitable for oral administration.


Lead Product(s): Zandelisib,Rituximab

Therapeutic Area: Oncology Product Name: ME-401

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Kyowa Kirin

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2022

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