DONG-A-ST
17.7.2023 15:01:34 CEST | Business Wire | Press release
Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).
Accord, a wholly owned subsidiary of Intas Pharmaceuticals Ltd, submitted the MAA to EMA on June 23rd, and the EMA accepted the MMA submission on July 14th in CET.
The MAA submission is based on the results of an extensive analytical similarity assessment of DMB-3115 with that US and EU-sourced STELARA using current ‘state-of-the-art’ methods. The MAA submission also comprised the results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326). The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. As a result, the therapeutic equivalence between DMB-3115 and the reference product was verified, and no safety issues were observed.
DMB-3115 is a proposed biosimilar to Stelara®, a blockbuster drug developed by Janssen Biotech Inc., and for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It recorded 17.77 billion USD (IQVIA Accumulative Sales in 2022) and is one of the best-selling biologics.
Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management. Since then, Dong-A ST and Meiji Seika Pharma worked together to develop the drug.
In July 2021, the worldwide distribution rights, excluding Japan, South Korea, and certain Asian regions, were licensed to Intas Pharmaceuticals, a multinational pharmaceutical company. Intas Pharmaceuticals will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada.
“We are delighted to reinforce our partnership with Dong-a & Meiji for Accord Healthcare to file for global rights to this critical drug, reinforcing our commitment to improving access to high-quality biosimilar drugs for patients globally,” said Mr. Paul Tredwell, Executive Vice President of Accord Healthcare.
“We will spare no effort to ensure DMB-3115 is supplied to the global market by leveraging a strong partnership between Dong-A, Meiji, Intas, and Accord,” said Mr. Jaehong Park, President & CSO (Chief Science Officer) of DongA ST.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230717954728/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Rubedo’s RLS-1496 Reduces Actinic Keratosis Pre-Cancerous Skin Lesions by 46% at Four Weeks with Minimal Irritation in Preliminary Results of Phase 1b/2a Study28.5.2026 14:30:00 CEST | Press release
RLS-1496 is an investigational, first-in-class, disease-modifying, selective glutathione peroxidase 4 (GPX4) modulator that targets pathologic senescent and other stressed, aging cells that drive chronic, age-dependent diseases, such as AK, and represents a novel drug category — Adaptive SenoTherapeutics In recognition of May as Skin Cancer Awareness Month, Rubedo is calling attention to the myths and facts surrounding AKs — and to the urgent need for a new generation of treatments that are effective without the side-effect burden of today's options Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on selective cellular rejuvenation medicines targeting aging cells, today announced preliminary results from a Phase 1b/2a study of RLS-1496 in patients with actinic keratosis (AK), a common age-related condition resulting in precancerous skin lesions, that is most commonly seen after age 65.1 The open-label multi-center trial, conducted in the United States,
ExaGrid Wins 5 Industry Awards at Network Computing Awards 202628.5.2026 14:00:00 CEST | Press release
ExaGrid named “Company of the Year” for seventh year in a row ExaGrid®, the world’s largest independent backup storage vendor providing Tiered Backup Storage with the most Comprehensive Security and AI-Powered Retention Time-Lock for Ransomware Recovery, today announced that company was honored with five industry awards, including Air-gapped Ransomware Recovery Product of the Year, Bench Tested Product of the Year, Company of the Year, Data Protection Product of the Year, and the Storage Product of the Year during the Network Computing Awards ceremony, held in London on May 21, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528849813/en/ The ExaGrid team headed to the stage five times throughout the Network Computing Awards ceremony in London to accept awards for ExaGrid Tiered Backup Storage. Photo courtesy of Network Computing Awards. The Network Computing Awards are determined by public vote. The 2026 awards mark
Ardoq Launches AI-First Enterprise Architecture Platform28.5.2026 14:00:00 CEST | Press release
Custom Agents, Omnipresent AI Assistant, and AI Import Builder Automate an Estimated 40% of Routine EA Work; Tenneco Already Achieving 292% ROI on Ardoq AI Ardoq, named a 5x Leader in the Gartner® Magic Quadrant™ for Enterprise Architecture Tools, today launched its AI-first enterprise architecture (EA) platform. The release grounds every Ardoq AI output in customers' live architecture data and introduces a new generation of AI agents capable of automating an estimated 40% of routine EA work. Architects today are being asked to defend decisions that generic AI is generating in seconds. Application rationalization choices. ERP transformation roadmaps. AI governance reviews. The questions land on the architect's desk, but the analysis underneath increasingly comes from AI assistants that do not know the architecture. Generic agents reason on whatever document is in front of them, not on the live relationships between applications, dependencies, capabilities, and risks. Ask a generic LLM
European DataWarehouse Launches DealDox®, a Next-Generation Virtual Data Room Built specifically for the Securitisation Market28.5.2026 14:00:00 CEST | Press release
European DataWarehouse (EDW) announced today the launch of DealDox®, a secure virtual data room uniquely tailored to the needs of the securitisation and structured finance market. Developed in response to long‑standing challenges around transaction data and document management, DealDox provides a single, secure environment where all parties throughout the deal lifecycle can collaborate efficiently while maintaining high standards of security, governance, and regulatory alignment. DealDox enables the centralised management of transaction data and documentation, offering robust security, granular access controls, and clear audit trails. The platform integrates seamlessly with EDW’s existing regulatory reporting ecosystem, supporting smoother workflows from deal preparation through to disclosure and compliance. “As a market infrastructure, our role is to reduce complexity and make processes simpler and more transparent for all participants,” said Dr. Christian Thun, CEO of European DataWa
SLB and Vår Energi Expand Digital Collaboration to Scale Well and Integrated Field Development Planning28.5.2026 13:47:00 CEST | Press release
Agreement supports Vår Energi’s ambition to reduce time to first oil, building on multi-discipline, collaborative well planning workflows that reduce cycle times from months to days Global energy technology company SLB (NYSE: SLB) today announced an expanded collaboration with Vår Energi to scale well planning and integrated field development planning across its Norwegian Continental Shelf operations. With collaborative well planning already reducing cycle times from months to days and integrated field development planning expected to support similar benefits, the expanded deployment is designed to support faster, more consistent decision-making as operators work to sustain production from mature offshore assets while managing increasing development complexity. As part of the expanded collaboration, Vår Energi is deploying the Delfi™ digital platform to connect exploration, subsurface evaluation, well planning, subsea design, field development planning, and production in a cloud-native
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom