Dong-A ST licenses Stelara biosimilar technology to multinational pharmaceutical company Intas

Dong-A ST and Partner Meiji Seika Pharma, Exclusive R&D and Finished Product Supply of DMB-3115

[Asia Economy Reporter Kim Ji-hee] Dong-A ST announced on the 21st that it has signed a global license-out (technology export) agreement with the multinational pharmaceutical company Intas for the currently developing Stelara biosimilar ‘DMB-3115’.

Under this agreement, Dong-A ST and its strategic alliance partner Meiji Seika Pharma will be responsible for the research and development and exclusive supply of the finished product of DMB-3115. Intas will hold exclusive rights for approval and sales in global regions excluding certain Asian countries such as Korea and Japan. After commercialization, product manufacturing will be handled by DM Bio, a CDMO (contract development and manufacturing organization) specialized affiliate of Dong-A Socio Holdings for biopharmaceuticals.

Additionally, Dong-A ST will receive a non-refundable upfront payment of $10 million (approximately 11.5 billion KRW) from Intas, milestone payments totaling $95 million (approximately 1.092 trillion KRW), and double-digit royalties on product sales profits.

DMB-3115 has been jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma since 2013. In July of last year, the rights for development and commercialization were transferred to Dong-A ST to efficiently carry out the global development project, and currently, Dong-A ST and Meiji Seika Pharma are jointly progressing with the development.

Dong-A ST initiated Phase 3 clinical trials in the United States in the first quarter of this year, and in Europe, Phase 3 trials have started in Poland, Estonia, and Latvia. The trials in Europe are planned to proceed sequentially in a total of nine countries.

Stelara, developed by Janssen, is a biopharmaceutical that inhibits the activation of inflammatory cells. It is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. According to Janssen’s management performance report last year, it recorded sales of $7.77 billion (approximately 8.85 trillion KRW), making it a blockbuster product.

Intas is an Indian multinational pharmaceutical company with a global sales network in over 85 countries, with about 70% of its total sales last year recorded in global markets such as the United States and Europe. Notably, Intas was the first Indian pharmaceutical company to launch biosimilars in the US and Europe. Intas plans to proceed with approval and sales in the US and Europe through its biosimilar-specialized affiliate Accord Healthcare in the UK.

A Dong-A ST official said, "The contract with Intas, which has extensive global biopharmaceutical research and development and market experience, has laid the foundation for Dong-A Socio Group’s 2025 vision of ‘becoming a global healthcare player by securing differentiated competitiveness in all business areas.’ We will focus all our company capabilities and do our best to ensure the success of the ongoing global Phase 3 clinical trials.”

This content was produced with the assistance of AI translation services.