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A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia in China

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Trial Profile

A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia in China

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2025

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At a glance

  • Drugs Ongericimab (Primary) ; HMG-CoA reductase inhibitors
  • Indications Hypercholesterolaemia; Hyperlipidaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Junshi Biosciences
  • Most Recent Events

    • 11 Oct 2024 According to Shanghai Junshi Biosciences media release, this study is led by Academician Yaling HAN from the General Hospital of the Northern Theater Command of the People's Liberation Army of China.
    • 11 Oct 2024 According to Shanghai Junshi Biosciences media release, National Medical Products Administration (NMPA) has approved new drug applications (NDA) for ongericimab injection for the treatment of primary hypercholesterolemia and mixed dyslipidemia, based on results from this study.
    • 25 Apr 2023 According to a Junshi Biosciences - Impact Therapeutics (JV) media release, the National Medical Products Administration has accepted the new drug application for JS002. new drug application is mainly based on three registered clinical trials (JS002-003, JS002-004 and JS002-006).

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