Global Healthcare Company
Leading Innovative Precision Medicines
for Unmet Medical Needs
Global Healthcare Company
Leading Innovative Precision Medicines
for Unmet Medical Needs
Our Key
Therapeutic
Areas
Strategic R&D investments
for innovative pharmaceutical development
PRESS RELEASE
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Dong-A ST, SK bioscience, and Onconic Therapeutics are among 7 Innovative Pharmaceutical Companies
2024/12/30The Ministry of Health and Welfare said seven new companies, including Dong-A ST, SK bioscience, and Onconic Therapeutics, have been newly certified as Innovative Pharmaceutical Companies (IPCs) for 2024.The Ministry of Health and Welfare has newly certified seven new pharma firms as Innovative Pharmaceutical Companies. (Credit: Getty Images) Out of 25 new companies reviewed for the certification, seven passed the evaluation process. They are Dong-A ST, SK bioscience, Onconic Therapeutics, Curocell, HanAll Biopharma, SK biopharmaceuticals, and Amgen Korea.The certification recognizes companies that have invested heavily in research and development (R&D) and made outstanding achievements in new drug development.Since 2012, the ministry has evaluated and certified companies as IPC under the Special Act on Fostering and Support of the Pharmaceutical Industry. To qualify, companies must maintain R&D investment ratios exceeding specified thresholds and demonstrate excellence in R&D for new drugs.Companies with annual pharmaceutical sales below 100 billion won ($67.9 million) must allocate at least 7 percent of their revenue to R&D, while those with sales exceeding 100 billion won must allocate at least 5 percent. Companies with U.S. or European Good Manufacturing Practice (GMP) certifications need only a 3 percent R&D investment ratio to qualify, provided they demonstrate strong performance in new drug R&D.Certified companies benefit from various advantages, including preferential drug pricing, tax incentives, and streamlined regulatory support.The certification is valid for two years for new recipients and three years for extensions. Five companies—Alteogen, ABL Bio, Ildong Pharmaceutical, AstraZeneca Korea, and Janssen Korea—were reviewed for certification renewal and successfully passed. With the newly certified companies, the total number of IPCs in Korea now stands at 49.“We will continue to support these innovative pharmaceutical companies by promoting expanded investments in R&D and fostering innovation,” said Jung Eun-young, director-general of the ministry’s Health Industry Bureau. “Additionally, we aim to refine the system and develop comprehensive measures to encourage ongoing success in the industry.” Source : https://www.koreabiomed.com/news/articleView.html?idxno=26172
2025-01-08
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Dong-A ST Secures European Approval for Stelara Biosimilar IMULDOSA
2024/12/19SEOUL, South Korea--(BUSINESS WIRE)--Dong-A ST (CEO: Jeong Jae-hoon, KRX: 170900) proudly announces that its Stelara biosimilar, IMULDOSA (Project Name: DMB-3115, Active Ingredient: Ustekinumab), has received marketing authorization from the European Commission (EC) as of December 18.“With the consecutive approvals in the United States and Europe, IMULDOSA is now one step closer to entering the global pharmaceutical market. We will continue to dedicate our efforts to ensure that IMULDOSA establishes a strong presence in the market, providing an effective treatment option to patients worldwide.”Post thisThis landmark approval comes just two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicine Agency (EMA) recommended the product for approval in October. Combined with its successful U.S. Food and Drug Administration (FDA) approval in October, IMULDOSA is now fully authorized to enter the global market.IMULDOSA, a biosimilar referencing Stelara of Janssen Pharmaceuticals, is indicated for treating inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease.Stelara, with its active ingredient ustekinumab, is among the top-grossing biologics worldwide, generating $20.323 billion in cumulative global sales in 2023, according to IQVIA.The development of IMULDOSA began in 2013 as a joint project between Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, the development and commercialization rights held by Dong-A Socio Holdings were transferred to Dong-A ST to ensure the efficient execution of the global project. Since then, Dong-A ST and Meiji Seika Pharma have continuously collaborated to develop it.In July 2021, Dong-A ST signed a global out-licensing agreement with multinational pharmaceutical company Intas Pharmaceuticals for IMULDOSA. Through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK, and Canada, IMULDOSA is set to be launched in multiple regions.A representative for Dong-A ST commented, “With the consecutive approvals in the United States and Europe, IMULDOSA is now one step closer to entering the global pharmaceutical market. We will continue to dedicate our efforts to ensure that IMULDOSA establishes a strong presence in the market, providing an effective treatment option to patients worldwide.”Source: https://www.businesswire.com/news/home/20241219254328/en/Dong-A-ST-Secures-European-Approval-for-Stelara-Biosimilar-IMULDOSA
2025-01-08
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CHMP Recommends the Approval of Dong-A ST’s IMULDOSA, a Biosimilar to STELARA®
2024/10/21 IMULDOSA obtained an approval recommendation from CHMP, who often sets the course of an EU marketing authorisation SEOUL, South Korea, October 21, 2024--(BUSINESS WIRE)--Dong-A ST (President/CEO Jae-Hun Jung, KRX:170900) announced on October 18th that its biosimilar IMULDOSA® (active ingredient: ustekinumab, development code DMB-3115), referencing Stelara®, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).Accord Healthcare Limited (Accord), a subsidiary of Intas Pharmaceuticals and Dong-A ST’s partner, submitted the Marketing Authorisation Application (MAA) to the EMA in June 2023. On October 18th (CET), the CHMP issued a recommendation for approval, further advancing DMB-3115’s journey toward the European Union.The CHMP evaluates medicinal products based on scientific assessments of their quality, safety, and efficacy, providing guidance to the EMA. A positive CHMP recommendation is typically a key determinant in the European Commission’s (EC) marketing approval and after the CHMP Marketing Authorization Opinion, the EC decides whether to grant an official marketing authorization.This achievement follows Dong-A ST’s success earlier this month, securing FDA approval for IMULDOSA® on October 10, showcasing its R&D excellence to the world.The biosimilar aims to treat-various immunology conditions, by offering an alternative to Stelara®, originally developed by Janssen Biotech.Stelara® is indicated for range of immunology indications and has recorded global sales of US$ 19 billion of which US$ 3.2 billion sales coming from Europe as per IQVIA MAT Jun’24 data.IMULDOSA® has been under joint development since 2013 by Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, Dong-A ST took over the R&D and commercialisation responsibilities to streamline global project management. A year later, the company signed a global licensing agreement with Intas Pharmaceuticals, paving the way for the biosimilar’s commercialisation through Accord BioPharma in the US and Accord Healthcare in the EU, UK, and Canada.Dong-A ST stated that its R&D expertise has been reaffirmed by the positive CHMP opinion, following the FDA approval for IMULDOSA. The company also added that it is now focused on a successful launch of IMULDOSA in both the US and European markets, aiming to provide better treatment options for patients worldwide. Source: https://www.businesswire.com/news/home/20241021420544/en/
2024-10-23
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