Business Wire

DONG-A-ST

Share
Dong-A ST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in Global Phase III

Dong-A ST (President and CEO: Min-young Kim) (KRX:170900) announced on January 16th that therapeutic equivalence and safety were established between DMB-3115 and Stelara, the reference drug, in global phase III.

Stelara is a blockbuster drug developed by Janssen Biotech Inc. and indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis; it recorded USD 16.8 billion (IQVIA, MAT Sept 2022) sales worldwide, making it one of the highest grossing biologic medicines.

DMB-3115 global phase III first kicked off in the US back in 2021 and then in eight European countries, including Poland, Estonia, and Latvia, with a total patient number of 605 over 52 weeks. Patients with moderate to severe chronic plaque psoriasis were treated with DMB-3115 or Stelara PFS to compare efficacy, safety, and immunogenicity. The trial was performed as a randomized, double-blinded, multicenter, parallel, and active-control study.

In accordance with the recommendation from the regulatory agencies, primary endpoint time frames were set as Week 8 and Week 12 for the EMA and the FDA, respectively.

DMB-3115 and Stelara demonstrated therapeutic equivalence when looking at percent change from baseline in PASI (Psoriasis Area and Severity Index) at Week 8 and Week 12. Similarly, there was no clinically significant difference in safety.

As the results are met for their differing recommendation of EMA and the FDA, the data is expected to be received more positively when submitted for marketing authorization to the respective agencies.

Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights of Dong-A Socio Holdings 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 for the development of the drug.

In July 2021, Dong-A ST and Meiji Seika Pharma signed a global license agreement with Intas, a leading multinational pharmaceutical company, and granted the exclusive rights for regulatory approval and commercialization of DMB-3115 in the territories excluding Korea, Japan and some Asian countries. DMB-3115 will be commercialized by Intas through its worldwide affiliates including Accord Biopharma in the US and Accord Healthcare in Europe, the UK and Canada. Dong-A ST and Meiji Seika Pharma are responsible for R&D and supply of the product to Intas and its worldwide affiliates.

Binish Chudgar, Vice-Chairman & Managing Director of Intas Pharmaceuticals, said, "This agreement with Dong-A ST and Meiji Seika Pharma emphasizes our commitment to acquiring advanced research to leverage our leadership position internationally. Further supporting our dedication to drive our mission of making world-class drugs more accessible to patients, globally."

Min-young Kim President & CEO Dong-A ST, said, “We will leverage the successful global phase III of DMB-3115 and submit the marketing authorization application for the US and the EU in the first half of 2023,” and continued, “We are committed to supplying DMB-3115 to the global market at the earliest date possible through close cooperation with Intas Pharmaceuticals.”

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/20230117005498/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 20:30:00 CEST | Press release

Pacifico Mexinol project, a 6,130 MT per day ultra-low carbon methanol production facility worth more than US$3.3b will be located near Topolobampo, Ahome, Sinaloa. Once operational in 2029, Pacifico Mexinol is poised to be the largest standalone ultra-low carbon chemical production facility in the world. Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s techn

Westinghouse and ITER Sign a $180M Contract to Advance Nuclear Fusion30.6.2025 15:45:00 CEST | Press release

The contract includes the assembly of the fusion reactor’s vacuum vessel, a key milestone which gets the project closer to replicating fusion energy on Earth Westinghouse Electric Company and ITER signed a contract for $180 million for the assembly of the vacuum vessel for the fusion reactor. This is a key milestone in the construction of the ITER reactor, leading the way toward the use of fusion as a practical future source of reliable carbon-free energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630497810/en/ The ITER Tokamak pit with the two vacuum vessel sector modules installed. Westinghouse has participated in the fabrication of the sectors of the vacuum vessel, as part of the Fusion for Energy (F4E) Consortium with its partners Ansaldo Nucleare and Walter Tosto. Westinghouse will be responsible for completing the vacuum vessel which is ITER’s most critical component: a hermetically sealed, double-walled steel

Monetate Acquires SiteSpect to Deliver AI-Native Personalization and Testing at Enterprise Scale30.6.2025 15:00:00 CEST | Press release

Monetate’s Real-Time Personalization Unites with SiteSpect’s Zero-Flicker Testing to Optimize Digital Experiences with Unmatched Speed, Precision, and SecurityNow Global Ecommerce and Digital Experience Leaders Can Access a Best-in-Class, Enterprise-Grade Personalization, Testing, and Optimization Platform Monetate, the leading AI-driven personalization platform, today announced it has acquired SiteSpect, a leader in A/B testing, to drive next-generation digital experience optimization. This acquisition accelerates Monetate’s vision to deliver intelligent, intentional, and individualized experiences at scale, powered by agentic AI and backed by the industry’s most advanced, enterprise-grade infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630514541/en/ The combination of Monetate’s real-time personalization and SiteSpect’s zero-flicker testing will yield an industry-first solution for enterprise-grade person

SS&C Blue Prism Recognized as a Gartner® Magic Quadrant™ RPA Leader for the Seventh Consecutive Year30.6.2025 15:00:00 CEST | Press release

SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that SS&C Blue Prism has been recognized as a Leader in the 2025 Gartner Magic Quadrant for Robotic Process Automation (RPA). “We’re delighted SS&C Blue Prism has been named a Leader in the Gartner Magic Quadrant for Robotic Process Automation for the seventh year running,” said Bill Stone, CEO and Chairman of SS&C Technologies. “SS&C Blue Prism combines market-leading RPA and orchestration technologies with the latest artificial intelligence so organizations can tackle more complex tasks and dynamic business processes. We’ve scaled to more than 2,700 digital workers and AI agents across our own operations, resulting in over $200 million in annual savings. With SS&C leading the charge on deployment, customers can be confident in rolling out SS&C’s automation solutions securely, effectively, and responsibly.” More than 2,800 companies worldwide leverage SS&C Blue Prism for AI-powered automation, helping organizations delive

Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content130.6.2025 14:00:00 CEST | Press release

GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in Company’s Differentiated Immunoglobulin Portfolio of Ready-to-Use Liquids2 Takeda(TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administratio

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye