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
The Premier Jumping League (PJL) & McCarthy Jumping Team Announce Landmark Purchase29.6.2026 16:10:00 EEST | Press release
The Premier Jumping League (PJL) today announced that seasoned trader, investor, and competitive race car driver Jason McCarthy and McCarthy Jumping League LLC acquired the first PJL team in a landmark $50 million acquisition, building on rising momentum for the highly acclaimed professional jumping league. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629512997/en/ The Premier Jumping League (PJL), photographed by Daniel Benson. The milestone investment represents an unprecedented valuation for a team in a newly established sports competition and underscores the confidence that sophisticated investors are placing in the PJL. The inaugural PJL season is scheduled to commence in April 2027. McCarthy brings extensive investment and trading experience to the League, having held leadership positions across the financial sector throughout his career. A graduate of MIT, McCarthy is the Founder and Managing Principal of a propr
InvestEco Sustainable Food Fund IV Holds a Final Close With Total Commitments of C$106M29.6.2026 16:00:00 EEST | Press release
InvestEco Capital is pleased to announce the final close of the InvestEco Sustainable Food Fund IV. This fund will continue InvestEco’s work of investing in high-growth food companies that promote health and sustainability in the food sector. The Fund closed with total commitments of C$106M, the largest InvestEco fund to date. Investors include Farm Credit Canada, Export Development Canada, Business Development Bank of Canada, Fonds de solidarité FTQ, and two Government of Canada Social Finance Fund wholesalers: Boann and Realize Capital Partners. In addition, the Fund received commitments from a number of private investors and family offices. The Fund's investments to date include Humble Snacks, Little Sesame, Mid-Day Squares and Algae Cooking Club. The Fund expects to make a further 6 - 10 investments over the next few years. InvestEco Capital, founded in 2002, is a Toronto-based venture capital firm and impact investor focused on the sustainable food sector. For more information, em
Geoswift and SKUx Announce Strategic Partnership to Develop a First-of-Its-Kind Programmable Stablecoin Commerce Network29.6.2026 15:00:00 EEST | Press release
Geoswift and SKUx announced a groundbreaking partnership to develop a next-generation programmable stablecoin commerce network. This strategic collaboration bridges digital assets, traditional finance, and real-world commerce at a global scale, representing a "one-of-one" opportunity by combining Geoswift's global infrastructure with SKUx's specialized item-level controls directly within point-of-sale (POS) systems. While enterprise stablecoin usage continues to accelerate globally, governments, enterprises, payment networks, and AI-driven commerce platforms are increasingly seeking programmable payment infrastructure that can bridge digital assets with real-world commerce. The innovation goes far beyond treasury management or even enabling consumers to spend stablecoins at retail locations. Instead, it unlocks true "programmable money" with embedded controls, rules, and purpose-driven utility —requiring both programmable settlement and programmable spending controls. Geoswift and SKUx
Esri Sponsors Smithsonian Exhibition Showcasing Natural and Cultural Objects from All 50 States29.6.2026 15:00:00 EEST | Press release
Esri, the global leader in location intelligence, is sponsoring From These Lands: Sharing Our Natural and Cultural Heritage, a new exhibition at the Smithsonian's National Museum of Natural History that showcases objects from all 50 states and explores the deep connections between people, place, and the natural world that unite the nation. The exhibit, which opened this June 18 and runs through 2029, brings together more than 600 specimens and cultural artifacts from across the United States, Washington, DC, and the five territories that people call home. Drawing from the museum's own collection, From These Lands shows how natural systems, cultural traditions, and geography intersect. The exhibition presents stories that span millions of years—from ancient fossils and geological formations to cultural artifacts and scientific breakthroughs—inviting visitors to reflect on their own sense of place. By pairing natural specimens with cultural objects, From These Lands demonstrates how huma
Cartilage Tissue Engineering Heads to Orbit in NSF and NASA-supported Study at the International Space Station29.6.2026 15:00:00 EEST | Press release
Researchers in the DELTAi Lab at the University of California, Irvine, working with NASA, are using Evercode Cell Fixation to preserve samples aboard the International Space Station as part of a study of cartilage tissue engineering in microgravity. The unprecedented work, part of a National Science Foundation (NSF)-funded grant led by Dr. Wendy Brown and Dr. Kyriacos Athanasiou, announced today by Parse Biosciences, aims to advance treatments for the hundreds of millions of people worldwide affected by cartilage injury. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260629548658/en/ Rachel Nordberg, PhD, from the DELTAi Lab at UC Irvine, prepping the BioServe device before it goes into orbit. Cartilage injuries cause significant pain and disability, and the need for implants that can repair or regenerate damaged tissue without harming a donor site has gone unmet for decades. Part of the difficulty is gravity itself, which m
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