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Meiji Seika Pharma Co., Ltd.: Meiji Seika Pharma: Promising Results of Phase I Clinical Trial of DMB-3115, a Proposed Ustekinumab Biosimilar, and Initiation of Phase III Clinical Trial in Patients With Plaque Psoriasis

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Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi, "Meiji") today announced that the bioequivalence of DMB-3115, a proposed ustekinumab biosimilar, has been demonstrated in phase I clinical trial compared to the reference products marketed in Europe and the United States. Meiji also announced the initiation of phase III multi-regional clinical trial in patients with plaque psoriasis. Those clinical trials are conducted in collaboration with Dong-A Socio Holdings (Headquarters: Seoul, Korea, CEO: Jong Hyun Han, "Dong-A").
DMB-3115 is a proposed biosimilar to ustekinumab, a recombinant monoclonal antibody for the treatment of patients with several inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Meiji and Dong-A are co-developing DMB-3115 under the strategic collaboration partnership agreement on biosimilars signed in September 2011. DMB-3115 is produced by using Sp2/0 cells, the same as those used in reference products to achieve high similarity in quality aspects.

Seoul , Soult-ukpyolsi , South-korea , Japan , Tokyo , United-states , Daikichiro-kobayashi , Kostenloser-wertpapierhandel , Jong-hyun-han , Business-development-dept , Donga-socio-holdings-headquarters , Meiji-seika-pharma-co-ltd

Meiji Seika Pharma Co., Ltd.: CORRECTING and REPLACING Meiji Seika Pharma: Promising Results of Phase I Clinical Trial of DMB-3115, a Proposed Ustekinumab Biosimilar, and Initiation of Phase III Clinical Trial in Patients With Plaque Psoriasis

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First paragraph, third sentence of release dated May 20, 2021, should read: Those clinical trials are conducted in collaboration with Dong-A Socio Holdings (Headquarters: Seoul, Korea, CEO: JUNG Jae-Hun, "Dong-A"). (instead of Those clinical trials are conducted in collaboration with Dong-A Socio Holdings (Headquarters: Seoul, Korea, CEO: Jong Hyun Han, "Dong-A").).
The updated release reads:
MEIJI SEIKA PHARMA:
PROMISING RESULTS OF PHASE I CLINICAL TRIAL OF DMB-3115, A PROPOSED USTEKINUMAB BIOSIMILAR, AND INITIATION OF PHASE III CLINICAL TRIAL IN PATIENTS WITH PLAQUE PSORIASIS
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi, "Meiji") today announced that the bioequivalence of DMB-3115, a proposed ustekinumab biosimilar, has been demonstrated in phase I clinical trial compared to the reference products marketed in Europe and the United States. Meiji also announced the initiation of phase III multi-regional clinical trial in patients with plaque psoriasis. Those clinical trials are conducted in collaboration with Dong-A Socio Holdings (Headquarters: Seoul, Korea, CEO: JUNG Jae-Hun, "Dong-A").

Seoul , Soult-ukpyolsi , South-korea , Japan , Tokyo , United-states , Daikichiro-kobayashi , Kostenloser-wertpapierhandel , Jong-hyun-han , Business-development-dept , Donga-socio-holdings-headquarters , Meiji-seika-pharma-co-ltd