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A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE)

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Trial Profile

A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2023

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At a glance

  • Drugs Telitacicept (Primary) ; Anti-inflammatories; Antimalarials; Corticosteroids; Immunomodulators; Immunosuppressants
  • Indications Systemic lupus erythematosus
  • Focus Registrational; Therapeutic Use
  • Sponsors RemeGen

Most Recent Events

  • 18 Dec 2023 According to a RemeGen media release, the product was first added to the updated National Reimbursement Drug List (NRDL) on Dec, 2021 and on January 1, 2024, the updated National Reimbursement Drug List (NRDL) will continue to include Telitacicept (RC18).
  • 22 Nov 2023 According to a RemeGen media release, based on results from this trial the NMPA has given full approval to Telitaciceptfor treating systemic lupus erythematosus (SLE).
  • 03 Jun 2023 Results assessing efficacy and safety of telitacicept, presented at the 24th Annual Congress of the European League Against Rheumatism.

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