Dong-A ST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in Global Phase III
17.1.2023 17:00:00 EET | Business Wire | Press release
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/
Contact information
Dong-A ST CO., Ltd
Shin-Hee Park
+82-32-610-2481
sh-park@donga.co.kr
Ji-Su Song
+82-920-8866
songjs@donga.co.kr
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Kingswood Capital Management Raises $4 Billion Across Two Oversubscribed Middle-Market Funds30.7.2026 18:00:00 EEST | Press release
Kingswood Capital Management, L.P. (together with its affiliates, “Kingswood”), a Los Angeles-based investment firm focused on the middle-market, today announced the final closing of Kingswood Capital Opportunities Fund IV, L.P. (together with its parallel fund, “Fund IV”), with total capital commitments of $3.1 billion, as well as Kingswood Capital Opportunities Small Cap Fund I, L.P. (together with its parallel fund, “Small Cap Fund I”), with total capital commitments of $900 million. These funds more than double Kingswood’s total assets under management (“AUM”) to over $7 billion. Fund IV represents the fourth institutional fundraise in five years for Kingswood and is more than double the size of Fund III. Both Fund IV and the inaugural Small Cap Fund I were significantly oversubscribed in just five weeks. Fund IV exceeded its initial target of $2.25 billion, while Small Cap Fund I exceeded its initial target of $550 million and both closed at their hard caps. The successful fundrai
CyrusOne Names John Hatem Chief Executive Officer to Accelerate its Global Digital Infrastructure Strategy30.7.2026 16:30:00 EEST | Press release
CyrusOne (the “Company”), a leading global data center owner, developer and operator, today announced the appointment of John Hatem as Chief Executive Officer and a member of the Company’s Board, effective immediately. As part of the Company’s long-term succession planning, Eric Schwartz, who successfully led CyrusOne through a period of significant expansion, is stepping down as CEO and will work together with Hatem to ensure a smooth transition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730005910/en/ John Hatem Hatem joined CyrusOne in 2011 and has held a series of increasingly senior roles across the business. He most recently served as President, responsible for global sales, global procurement, and design, engineering, and construction in the United States. His deep experience in data center design, development, and operations has helped transform CyrusOne into one of the world’s leading digital infrastructure p
Mary Kay Releases 2026 Sustainability Report Highlighting Transformative Progress Across Social, Economic, and Environmental Impact Globally30.7.2026 15:03:00 EEST | Press release
Mary Kay Inc., a leading global beauty company committed to sustainability and women’s empowerment, today released its 2026 Sustainability Report, outlining progress toward its 2030 goals and celebrating the 2025 and latest achievements that continue to drive positive change globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730240667/en/ Mary Kay's annual 2026 Sustainability Report highlights the company's decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in Mary Kay's mission of “enriching women’s lives” around the world. (Image Credit: Mary Kay Inc.) The annual report highlights Mary Kay’s decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in the company’s mission of “enriching women’s lives”
Veracode Launches “Veracode Marketplace”: A Curated Ecosystem of Elite Security Integrations Built for the AI-Powered Software Development Era30.7.2026 15:00:00 EEST | Press release
Veracode, the global leader in application risk management, today announced the launch of the Veracode Marketplace, a curated ecosystem that gives customers a single, trusted destination to discover, evaluate, and deploy third-party security integrations as an extension of the Veracode platform. The marketplace debuts with DryRun Security as its inaugural partner, delivering AI-native contextual analysis and verification to Veracode customers on day one. A New Standard for the AppSec Ecosystem The Veracode Marketplace enables security and engineering teams to extend their existing Veracode investment with validated, best-in-class integrations. Every partner is vetted for technical depth, product quality, and workflow fit. Integrations are anchored to Veracode findings for a unified audit trail, and every purchase goes through a single procurement path on a single contract, with a personalized support experience. “Application security has entered a new era, and no single vendor will sol
INNIO Awarded EcoVadis Platinum Medal for Fifth Consecutive Year30.7.2026 15:00:00 EEST | Press release
INNIO N.V. (Nasdaq: INIO) has been awarded the EcoVadis Platinum Medal, the highest recognition granted by the globally trusted provider of business sustainability ratings. This marks the fifth consecutive year that INNIO has achieved Platinum status since 2022. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730309718/en/ INNIO N.V. Awarded EcoVadis Platinum Medal for Fifth Consecutive Year In the latest assessment cycle, INNIO further improved its overall EcoVadis score compared to the previous year by introducing additional policies and further strengthening its sustainability management system. “This recognition is a strong validation of our sustainability strategy,” said Marcin Kawa, Vice President Sustainability at INNIO. “Achieving EcoVadis Platinum status for the fifth consecutive year shows that we have consistently delivered on our sustainability commitments and embedded responsible business practices throughout
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