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              I-Mab Biopharma

              • Development Update

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              CHINA China

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              I-Mab Receives China CDE Approval to Initiate Phase 3 Clinical Trial of Eftansomatropin in Pediatric Patients with Growth Hormone Deficiency

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              Lead Product(s): Eftansomatropin

              Therapeutic Area: Endocrinology Product Name: TJ101

              Highest Development Status: Phase II Product Type: Peptide

              Partner/Sponsor/Collaborator: Genexine

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 30, 2020

              Details:

              The phase 3 trial is a study designed to assess the safety, efficacy and pharmacokinetics of eftansomatropin in PGHD. The primary objective is to demonstrate non-inferiority of eftansomatropin administered in subcutaneous injection, compared to the active control Norditropin®.

              I-Mab Biopharma

              • Development Update

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              CHINA China

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              USP Workshop 2021

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              China NMPA Accepts IND Application for Eftansomatropin Pivotal Trial in Pediatric Patients with Growth Hormone Deficiency

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              Lead Product(s): Eftansomatropin

              Therapeutic Area: Endocrinology Product Name: TJ101

              Highest Development Status: Phase II Product Type: Peptide

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 04, 2020

              Details:

              The Phase 3 trial is a multi-center, randomized, open-label, active-controlled clinical study designed to assess the safety, efficacy and pharmacokinetics of eftansomatropin in PGHD.

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