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Eden Biologics

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Eden Biologics’ Leading Biosimilar Program Receives Phase 3 Approval in Europe

Details:

EB-CLIN-1001-03 phase 3 clinical trial for the leading biosimilar program EB1001, a Denosumab biosimilar, for the future treatment of osteoporosis, giant cell tumors of bone, and other skeletal-related events from metastatic solid tumors.

Lead Product(s): Denosumab

Therapeutic Area: Musculoskeletal Product Name: EB1001

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 August 31, 2021

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Eden Biologics

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First Subjects Dosed in JHL's Phase I Clinical Study of a Denosumab Biosimilar

Details:

The Three-Arm Study is randomized, double-blinded, parallel-grouped, and single-dosed and will compare the pharmacokinetic similarity of JHL1266 versus Prolia® sourced from the EU and the US in healthy human subjects.

Lead Product(s): Denosumab

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

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 18, 2020

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Eden Biologics

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First Subjects Dosed in Australian Phase I Clinical Study of a Denosumab Biosimilar

Details:

JHL1266, a proposed biosimilar to denosumab, is a monoclonal antibody targeting RANKL and works by inhibiting the development of osteoclasts and then preventing break down of bones in the human body.

Lead Product(s): Denosumab

Therapeutic Area: Musculoskeletal Product Name: JHL1266

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 18, 2020

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