Dong-A ST announced on Jan. 25 that it received approval from the U.S. FDA on Jan. 24 for phase 3 clinical trials of "DMB-3115," which is being developed as a treatment for chronic platelet psoriasis.
The DMB-3115 is a biosimilar of Ustekinumab developed by Janssen. Stella is a biopharmaceutical that blocks the p40 subunit of the immune mediators Interleukin (IL)-12 and Interleukin-23 and inhibits the activation of inflammatory cells.
It is a treatment for inflammatory diseases such as psoriasis and psoriasis arthritis, Crohn's disease and ulcerative colitis. Stelara is a blockbuster product that recorded sales of 7 trillion won based on IQVIA Data in 2019.
Dong-A Socio Holdings and Meiji Seica Pharma have been jointly developing DMB-3115 since 2013. In July last year, the rights to development and commercialization were transferred to Dong-A ST to efficiently carry out global projects, and Dong-A ST and Meiji Seica Pharma are currently jointly developing them.
Preclinical trials for DMB-3115 was completed in Europe and Korea in 2018, and clinical phase 1 has been underway in Europe to compare and evaluate the pharmacokinetic characteristics of DMB-3115 and Stelara for healthy adults since November 2019.
Dong-A ST plans to launch Phase III clinical trials in the U.S. within the first quarter and apply for Phase III clinical trials in nine European countries sequentially.
In order to dominate the global market early, the company plans to release Stelara in the U.S. and Europe in September 2023 and July 2024, respectively, when material patents expire after clinical completion.
An official from Dong-A ST said, "We will successfully complete the three-phase clinical trial of DMB-3115 and supply bio-medicine with excellent quality and economic feasibility to the world."
