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    [{"orgOrder":0,"company":"EirGenix","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Phase III Clinical Results for EirGenix's Proposed Trastuzumab Biosimilar","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"EirGenix","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Submits Biologics License Application for Proposed Biosimilar Trastuzumab to US FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2021","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":"EirGenix","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Receives Positive CHMP Opinion for Breast and Gastric Cancer Biosimilar Trastuzumab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"TAIWAN","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"EirGenix","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization by EC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"TAIWAN","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]

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              EirGenix

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              EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization by EC

              Details:

              EG12014, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).

              Lead Product(s): Trastuzumab

              Therapeutic Area: Oncology Product Name: EG12014

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Sandoz B2B

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 22, 2023

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              EirGenix

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              Sandoz Receives Positive CHMP Opinion for Breast and Gastric Cancer Biosimilar Trastuzumab

              Details:

              EG12014, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).

              Lead Product(s): Trastuzumab

              Therapeutic Area: Oncology Product Name: EG12014

              Highest Development Status: Phase III Product Type: Large molecule

              Recipient: Sandoz B2B

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 18, 2023

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              EirGenix

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              EirGenix's Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial Objectives

              Details:

              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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              Sandoz Submits Biologics License Application for Proposed Biosimilar Trastuzumab to US FDA

              Details:

              Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers. Sandoz is seeking approval for the same indications as the reference medicine.

              Lead Product(s): Trastuzumab

              Therapeutic Area: Oncology Product Name: EGI014A1

              Highest Development Status: Phase III Product Type: Large molecule

              Recipient: Sandoz B2B

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 20, 2021

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              Positive Phase III Clinical Results for EirGenix's Proposed Trastuzumab Biosimilar

              Details:

              The purpose of the trial was to demonstrate the therapeutic equivalence in terms of efficacy between EG12014 to Herceptin®, and to compare the safety, immunogenicity and PK between the two trastuzumab products.

              Lead Product(s): EG12014

              Therapeutic Area: Oncology Product Name: EG12014

              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 23, 2021

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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