Meiji Seika Pharma Co., Ltd. and Dong-A Socio Holdings Co., Ltd. Announces the Initiation of A Phase I Clinical Trial of Dmb-3115
December 15, 2019 at 08:00 pm EST
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Meiji Seika Pharma Co., Ltd. and Dong-A Socio Holdings Co., Ltd. announced the initiation of a Phase I clinical trial of DMB-3115. The Phase I clinical trial is a randomized double-blind, three-arm, single-dose study to compare pharmacokinetics, safety and tolerability of DMB-3115 with its reference products (US- and EU-marketed products under the name of Stelara®) in healthy volunteers at a single site in Europe. The dosing for subjects in the study was started on 13 December. Meiji and Dong-A are developing DMB-3115 as a biosimilar candidate to ustekinumab, a recombinant immunoglobulin G1kappa monoclonal antibody targeting interleukin (IL)-12 and IL-23. The reference product has been approved in many regions for the treatment of patients with several inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The investigational product of DMB-3115 for the Phase I study was manufactured by DM Bio Limited (Headquarters: Incheon, Korea, CEO: Byoung Jo Min), established as a joint venture company in Incheon Free Economic Zone, under the strategic collaboration partnership agreement on biosimilars between Meiji and Dong-A signed in September 2011.
Dong-A Socio Holdings Co Ltd is a Korea-based company mainly engaged in the production and sale of pharmaceuticals. The Company operates its business through five segments. The Medicine Manufacturing segment is engaged in the manufacture and sale of pharmaceuticals. The main pharmaceuticals include tonic medicines, cold medicines, raw material medicines. The Logistic segment is involved in the freight, courier, car transportation, freight warehousing and leasing business. The Packaging segment is engaged in manufacturing and sale of glass and glass products. The Holding Company segment is engaged in the provision of core companies and management consulting services. The Other segment is engaged in the production and sale of information and communication technology (IT) solutions and agricultural products, as well as real estate development business.