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  • Celltrion's CT-T43 was approved for Phase III clinical trial
  • by Kim, Jin-Gu | translator Choi HeeYoung | Jan 13, 2021 06:10am
Simultaneous global clinical trials, aiming to end in the second half of 2022
Celltrion announced on the 8th that it has received approval for the Phase III clinical trial plan of Stelara (Ustekinumab)'s biosimilar.

Janssen's autoimmune disease treatment Stelara is a mechanism that inhibits interleukin (IL)-12¡¤23, and has indications for psoriasis, Crohn's disease, and ulcerative colitis. It is known that global sales amount to ₩7 trillion.

Celltrion plans to compare the efficacy, pharmacokinetics, and safety of CT-T43 and Stelara at 7 domestic institutions.

Clinical trials are conducted simultaneously with global trials. Global clinical trials are conducted in Europe and Korea with 446 patients. Global clinical trials have already begun with European approval on December 21st
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