Athena Athena

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[{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Phase 3 Trial of Ranibizumab Biosimilar Candidate, SB11 to Treat Namd Meets Primary Endpoints","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Samsung Bioepis"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Begins Phase 3 Trial for Aflibercept Biosimilar","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Samsung Bioepis"},{"orgOrder":0,"company":"GtreeBNT","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Joint Venture GtreeBNT Expects to Complete Phase 3 Dry Eye Trial in November 2020","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Peptide","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Peptide","graph2":"GtreeBNT"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis Unveils Final Results of Phase 3 Clinical Trial for SB11","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Samsung Bioepis"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Accepts for Review Samsung Bioepis & Biogen\u2019s BLA for SB1, a Proposed Biosimilar Referencing Lucentis","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Samsung Bioepis"},{"orgOrder":0,"company":"Samsung Bioepis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Ranibizumab Biosimilar, BYOOVIZ\u2122","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Samsung Bioepis"},{"orgOrder":0,"company":"GtreeBNT","sponsor":"HLB Group","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RegeneRx Licensee Acquired by Korean Biopharmaceutical Group","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Peptide","graph2":"GtreeBNT"},{"orgOrder":0,"company":"Altos Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Altos Biologics, a Subsidiary of Alteogen, Completed Patient Enrollment in Global Phase 3 Clinical Trial of Eylea\u00ae Biosimilar in Neovascular Age-related Macular Degeneration","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Altos Biologics"}]

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            ALT-L9 (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor used to treat Neovascular (Wet) Age-Related Macular Degeneration (AMD), various types of macular edema and diabetic retinopathy.

            Lead Product(s): Aflibercept

            Therapeutic Area: Ophthalmology Product Name: ALT-L9

            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 22, 2023

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            Acquisition of GtreeBNT by HLB Group, would speed up the clinical trials currently in progress and allow the company to focus on new drug approval. RGN-259 will remain a priority for the company.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: HLB Group

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition September 27, 2021

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            Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: Byooviz

            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 June 25, 2021

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            If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe; BENEPALI™, IMRALDI™ and FLIXABI™.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: SB11

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Biogen

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 18, 2020

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            SB11 is the sixth biosimilar product and the first eye disease treatment that Samsung Bioepis developed after three autoimmune disease treatments (SB2, SB4, SB5) and two tumor disease treatments (SB3, SB8).

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: SB11

            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 November 12, 2020

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            ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.

            Lead Product(s): Thymosin Beta-4

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 2020

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            Details:

            The randomized, double-masked, parallel group, multicenter study will compare SB15 and reference Eylea on safety, efficacy, pharmacokinetics, and immunogenicity.

            Lead Product(s): Aflibercept

            Therapeutic Area: Ophthalmology Product Name: SB15

            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 June 30, 2020

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            Details:

            In a Phase 3 study, SB11 demonstrated equivalent efficacy in terms of change in best corrected visual activity (BCVA) at Week 8 and central subfield thickness (CST) at Week 4 to reference ranibizumab LUCENTIS®i in patients with neovascular age-related macular degeneration.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: SB11

            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 18, 2020

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