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Dong-A, Meiji Seika to conduct P1 trial for Stelara biosimilar
  • By Lee Han-soo
  • Published 2019.12.16 17:01
  • Updated 2019.12.16 17:01
  • comments 0

Dong-A Socio Holdings and Meiji Seika Pharmaceutical said they have started phase 1 clinical trial for DMB-3115 (Ingredient: Ustekinumab), a Stelara biosimilar, in EU.

Stelara is a biopharmaceutical developed by Janssen and treats plaque psoriasis in children 12 years and older, psoriatic arthritis, and Crohn's disease in adults.

The two companies have been developing the drug since 2013 and completed the pre-clinical in Korea in 2018, and will conduct the EU phase 1 clinical trial on 300 healthy adults using clinical samples from DM Bio.

"We have completed pre-clinical for DMB-3115 by employing our rich experience in developing and commercializing first-generation biopharmaceuticals, from growth hormone, anemia treatment Eporon, neutropenia treatment Leucostim, and infertility treatment Gonadopin," a company official said.

Starting with the first phase of the European trial, Dong-A Socio Holdings will work closely with Meiji Seika on the global commercialization of DMB-3115, the official added.


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