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A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody Injection in Subjects With Heterozygous Familial Hypercholesterolemia

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody Injection in Subjects With Heterozygous Familial Hypercholesterolemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Ongericimab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Junshi Biosciences

Most Recent Events

  • 27 May 2025 According to Shanghai Junshi Biosciences media release, drug approved by the National Medical Products Administration (NMPA) for two new indications for use in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia, either alone or in combination with ezetimibe in patients who are intolerant or contraindicated to statins, The approval of the two new indications is mainly based on the two registered clinical trials JS002-005 (NCT05325203) and JS002-007 (NCT05621070).
  • 27 May 2025 According to Shanghai Junshi Biosciences media release, study led by Professor Changsheng MA and Professor Jie LIN from Beijing Anzhen Hospital affiliated to Capital Medical University as the principal investigators.
  • 27 May 2025 According to Shanghai Junshi Biosciences media release, announced that the National Medical Products Administration (NMPA) has approved two supplemental new drug applications for the ongericimab injection for the treatment of heterozygous familial hypercholesterolemia, primary hypercholesterolemia and mixed dyslipidemia, based on JS002-005 (NCT05325203) and JS002-007 (NCT05621070) studies.

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