Dong-AST ended the clinical trial of Stelara biosimilar

9 countries including the United States and Europe...Target to apply for permission in the first half of next year

A panoramic view of Dong-A ST headquarters

Dong-AST announced on the 17th that the global phase 3 clinical trial of Stella biosimilar DMB-3115 has ended.

 

Phase 3 of global clinical trials of DMB-3115 was conducted for 52 weeks in a total of 605 patients in 9 countries, including Poland, Estonia, and Latvia, starting in the United States in 2021.

 

Phase 3 of this global clinical trial was conducted with random assignment, double-blinding, multi-organ, and active-controlled trials to compare the efficacy, safety, and immunogenicity of DMB-3115 and Stelara subcutaneous injection in moderate to severe chronic plate psoriasis patients.

 

Clinical samples produced by STGEN BIO, a biopharmaceutical CDMO affiliate of Dong-A Socio Holdings, were used.

 

Dong-AST plans to apply for DMB-3115 item permits in the U.S.

 

and Europe in the first half of 2023 when positive data are derived by analyzing the results of phase 3 global clinical trials.

 

Stelara, developed by Janssen, is a treatment for inflammatory diseases such as plate psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

 

It is a blockbuster product that recorded sales of 9.134 billion dollars (about 11.64 trillion won) last year.

 

Since 2013, Dong-A Socio Holdings has promoted the joint development of the DMB-3115 with Meiji Seika Pharma.

 

In July 2020, Dong-AST took over the right to develop and commercialize the global development project with the aim of promoting the efficiency of the global development project and jointly developed it with Meiji Seika Pharma.

 

In 2019, phase 1 European clinical trials comparing the pharmacokinetic properties of DMB-3115 and Stelara in healthy adults demonstrated pharmacokinetic similarities between DMB-3115 and Stelara.

 

Dong-AST signed a technology export contract for DMB-3115 with multinational pharmaceutical company Intas Pharmaceuticals in July last year.

 

Intas Pharmaceuticals has secured exclusive rights to licenses and sales in global regions except for Korea, Japan, and some Asian countries.

 

Global commercialization will be handled by Accord Healthcare, a subsidiary of Intas Pharmaceuticals.

 

Dong-AST and Meiji Seika Pharma are responsible for the research and development of DMB-3115 and for the exclusive supply of products to Intas and Accord Healthcare.