Le Lézard
Classified in: Health, Science and technology
Subject: Product/Service

Meiji Seika Pharma and Dong-A Socio Holdings Initiate Phase I Clinical Trial of DMB-3115, a Ustekinumab Biosimilar Candidate


Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi, "Meiji") and Dong-A Socio Holdings Co., Ltd. (Headquarters: Seoul, Korea, CEO: Jong Hyun Han, "Dong-A") today 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.


These press releases may also interest you

at 17:10
Bristol Myers Squibb and Acceleron Pharma Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an...

at 17:05
North Bud Farms Inc. ("NORTHBUD" or the "Company") announces, further to its news release of March 13, 2020, that the Company's principal regulator, the Ontario Securities Commission (the "Commission"), granted a management cease trade order...

at 17:05
AgraFlora Organics International Inc.  ("AgraFlora" or the "Company") , a growth oriented and diversified international cannabis company, is pleased to announce its key asset, Propagation Services Canada (the "Delta Facility") has completed...

at 17:00
Andlauer Healthcare Group Inc. ("AHG" or the "Company") will release its 2020 first quarter financial results after market close on Monday, May 11, 2020. Michael Andlauer, Chief Executive Officer, and Peter Bromley, Chief Financial Officer, will...

at 17:00
The Government of Canada is working closely with businesses and manufacturers nationwide to provide healthcare workers with the equipment they need to protect themselves and care for Canadians across the country. Today, the Government of Canada...

at 16:55
In the midst of the Covid-19 pandemic and what has been described by the World Health Organization (WHO) as a resulting "infodemic," Mucinex, a leading cold and flu brand, has launched a new public health information campaign in the US to help people...



News published on 15 december 2019 at 20:05 and distributed by: