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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"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
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Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
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
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