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    [{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Mundipharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mundipharma Enters Partnership With Samsung Bioepis to Expand Biosimilars Into Hong Kong and Taiwan","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis and AffaMed Therapeutics\u2019 Eculizumab Biosimilar Candidate Receives China IND Approval, Expanding the Ongoing Global Phase 3 Trial","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"January 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              Samsung Biologics

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              Samsung Biologics Partners with Legochem Biosciences for ADC Development and Manufacturing

              Details:

              Under the terms of the deal, Samsung Biologics will provide antibody development and drug substance manufacturing services as a part of LegoChem Biosciences' ADC program, including LCB73, a CD19-targeted ADC candidate for hematological tumors.

              Lead Product(s): LCB73

              Therapeutic Area: Oncology Product Name: LCB73

              Highest Development Status: Preclinical Product Type: Large molecule

              Partner/Sponsor/Collaborator: LegoChem Biosciences

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Partnership June 07, 2024

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              Samsung Bioepis

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              Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)

              Details:

              SB27 is the proposed biosimilar to keytruda (pembrolizumab), being investigated for the treatment of metastatic non-squamous non-small cell lung cancer.

              Lead Product(s): Pembrolizumab,Pemetrexed,Carboplatin

              Therapeutic Area: Oncology Product Name: SB27

              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 April 05, 2024

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              Samsung Bioepis

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              Samsung Bioepis Initiates Phase 1 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)

              Details:

              SB27 (pembrolizumab) is a Keytruda-biosimilar that is an anti-PD-1 antibody. It is being evaluated for the treatment of stage II-IIIA non-small cell lung cancer.

              Lead Product(s): Pembrolizumab

              Therapeutic Area: Oncology Product Name: SB27

              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 February 21, 2024

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              Samsung Bioepis

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              Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®

              Details:

              The agreement aims for the commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara (ustekinumab) in the United States (US).

              Lead Product(s): Ustekinumab

              Therapeutic Area: Dermatology Product Name: SB17

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Johnson & Johnson

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement November 30, 2023

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              Samsung Bioepis

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              Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA„¢ (adalimumab-bwwd)...

              Details:

              Hadlima (adalimumab-bwwd), a biosimilar of Humira (adalimumab), is a TNF blocker indicated to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Yusimry will be the first biologic product offered by the Cost Plus Drugs.

              Lead Product(s): Adalimumab-bwwd

              Therapeutic Area: Immunology Product Name: Hadlima

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Organon

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 07, 2023

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              Samsung Bioepis

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              Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate

              Details:

              Under the agreement, Sandoz will support Samsung Bioepis pipeline expansion by commercialising SB17, a proposed biosimilar to Stelara (ustekinumab) strengthening its immunology portfolio in the US, Canada, European Economic Area, Switzerland and UK.

              Lead Product(s): Ustekinumab

              Therapeutic Area: Dermatology Product Name: SB17

              Highest Development Status: Phase III Product Type: Large molecule

              Recipient: Sandoz B2B

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement September 11, 2023

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              Samsung Bioepis

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              Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar

              Details:

              HADLIMA (Adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.

              Lead Product(s): Adalimumab-bwwd

              Therapeutic Area: Immunology Product Name: Hadlima

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Organon

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 01, 2023

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              Samsung Bioepis

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              Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA (adalimumab-bwwd) in Multiple Presentations Consistent with Originator

              Details:

              HADLIMA (adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.

              Lead Product(s): Adalimumab-bwwd

              Therapeutic Area: Immunology Product Name: Hadlima

              Highest Development Status: Approved Product Type: Large molecule

              Recipient: Organon

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 01, 2023

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              Samsung Biologics

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              Samsung Biologics and Pfizer Announce Strategic Collaboration for Long-Term Manufacturing of Biosimilars Portfolio

              Details:

              Under the terms of the new agreement, Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.

              Lead Product(s): Undisclosed

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Undisclosed Product Type: Large molecule

              Partner/Sponsor/Collaborator: Pfizer Inc

              Deal Size: $411.0 million Upfront Cash: Undisclosed

              Deal Type: Collaboration June 08, 2023

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              Samsung Bioepis

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              Samsung Bioepis Receives Positive CHMP Opinion for Eculizumab Biosimilar, EPYSQLI™

              Details:

              Epysqli™ (eculizumab) is a mAb that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9 mediated intravascular hemolysis in PNH patients.

              Lead Product(s): Eculizumab

              Therapeutic Area: Rare Diseases and Disorders Product Name: Epysqli

              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 31, 2023

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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