Novotech Partners with Kyungpook National University Hospital to Strengthen Clinical Trial Capabilities in South Korea
18.3.2025 13:05:00 CET | Business Wire | Press release
Novotech, a global leading full-service clinical Contract Research Organization (CRO), and Acrostar, a provider of Site Management Organization (SMO) services have entered into a strategic partnership by signing a Memorandum of Understanding (MOU) with Kyungpook National University Hospital (KNUH). The partnership will support clinical trials across KNUH’s prestigious institutions including the Advanced Clinical Trials Center, the KNUH main campus, and the Chilgok KNUH in South Korea.
This collaboration is a key milestone for the advanced clinical trials in South Korea, strategically aligning with the amendments to the Advanced Regenerative Bio Act. This agreement builds upon the recent inauguration of KNUH’s Advanced Clinical Trials Center opened in November last year, marking its first official partnership post-amendment of the Bio Act.
The amendments to the Advanced Regenerative Bio Act expanded the scope of advanced regenerative medicine, allowing the use of investigational therapies in clinical trials and expanding the number of authorized regenerative medicine institutions. Previously limited to severe, rare, and incurable diseases, regenerative medicine applications will now extend to a broader range of conditions, including general diseases.
Patients outside of clinical trials will also gain access to regenerative medicine services, while the range of applicable technologies—including cell and gene therapies (CGT) and tissue engineering—has significantly expanded.
Under the previous framework, CGTs required formal drug approval for clinical application. With these regulatory changes, CGTs in clinical trials can now be utilized upon review committee approval, streamlining access to innovative therapies.
The partnership creates a comprehensive framework across KNUH’s network with early-stage clinical trials primarily conducted at the Advanced Clinical Trials Center, while late-stage trials will be managed with the KNUH’s hospital system itself.
Speaking at the ceremony, Prof. Hyungran Yoon, Director of the Advanced Clinical Trials Center, spoke about the benefits of the collaboration, “The Advanced Clinical Trials Center will oversee trials for all diseases treated at KNUH, strengthening our role as a leader in clinical research and regenerative medicine. The partnership agreement with Novotech will expand their capacity to offer innovative treatment opportunities both domestically and internationally.”
Dr. Yooni Kim, Managing Director, Asia-Pacific at Novotech, highlighted the strategic advantages. “This partnership combines Novotech’s global expertise with KNUH’s specialized capabilities to offer cutting-edge treatment solution and streamlined trial operations. By leveraging this synergy, we aim to boost South Korea’s position on the global stage in regenerative medicine and enhance clinical trial excellence worldwide.”
This partnership also marks a significant milestone for Acrostar, Novotech’s SMO services provider. Daniel Kim, Director of Acrostar Asia-Pacific, shared his excitement about the partnership, “This is Acrostar’s first partnership in South Korea. Through this collaboration, we will actively support the site and ensure the smooth progress of clinical trials from a site management perspective.”
This strategic partnership means a shared commitment to advancing clinical research in South Korea and contributing to the global development of regenerative medicine and advanced clinical trials.
About NovotechNovotech-CRO.com
Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech and small to mid-size companies to accelerate the development of advanced and novel therapeutics at every phase.
Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the Fierce CRO 2024 Excellence Award in Clinical Trial Management and Global Operations, Frost & Sullivan 2024 Global Biotech CRO of the year award, Clinical Trials Arena 2024 Excellence Awards in Business Expansion, Innovation and Marketing, 2024 Employer of Choice, 2024 Great Place to Work in the US, 2024 Brandon Hall Gold Award, CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.
The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.
For more information or to speak to an expert team member visit www.Novotech-CRO.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20250317570511/en/
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
Pacific Defense Awarded U.S. Marine Corps Contract for Next Generation Electronic Warfare Prototype29.4.2026 13:00:00 CEST | Press release
Award advances SOSA/CMOSS mission system ecosystem and informs future EW fielding decisions Pacific Defense has been awarded a 12-month rapid prototyping contract by the U.S. Marine Corps Systems Command (MARCORSYSCOM), Program Manager for Tactical Communications and Electronic Warfare (PM TCE) to support next-generation electronic warfare (EW) capability evaluation. The effort will assess Modular Open Systems Approach (MOSA) Electronic Warfare (EW) mission systems and their potential in modernizing USMC capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429918712/en/ Pacific Defense's Next Generation Electronic Warfare System enables rapid integration of new hardware and software into a common chassis, accelerating capability insertion while reducing vendor lock and lifecycle costs. Under the contract, Pacific Defense will deliver SOSA/CMOSS-aligned mission systems to enable vehicle-based experimentation by U.S
Visa Accelerates Stablecoin Momentum: Adding Five Blockchains for Settlement29.4.2026 13:00:00 CEST | Press release
Stablecoin settlement pilot sees record growth 50% quarter over quarter, reaching $7B run rate. Today, Visa (NYSE: V) announced that it is adding five blockchains to its global stablecoin settlement pilot, expanding how issuers and acquirers can settle with the network. As stablecoins move into mainstream payment flows, Visa’s stablecoin settlement pilot now supports nine blockchains and has reached a $7 billion annualized stablecoin settlement run rate, up 50% since last quarter. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429143049/en/ Visa is adding support for five additional blockchains, further expanding its multi-chain settlement capabilities. “Our partners are building in a multi-chain world, and they expect their options to reflect that reality,” said Rubail Birwadker, Global Head of Growth Products and Strategic Partnerships, Visa. “Expanding our stablecoin settlement pilot program to more blockchains means o
U.S. FDA Grants Priority Review to BeOne Medicines’ TEVIMBRA in First-Line HER2+ GEA29.4.2026 12:00:00 CEST | Press release
TEVIMBRA plus ZIIHERA and chemotherapy regimen delivered statistically significant median OS of 26.4 months, an unprecedented result in this challenging diseaseResults from the global Phase 3 HERIZON-GEA-01 study demonstrate potential to change clinical practice in advanced HER2+ gastroesophageal adenocarcinoma BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma. The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indica
European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe29.4.2026 11:30:00 CEST | Press release
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429686426/en/ “As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women in the European Union,” said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon.2,3 “Organon’s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of healt
Andreas Goppelt Appointed Managing Director of OrphaCare29.4.2026 10:27:00 CEST | Press release
OrphaCare, a global specialist for the development and marketing of medical devices for drug delivery and part of the AOP Health Group, has appointed Andreas Goppelt as its new Managing Director, succeeding Georg Fischer. In this role, the seasoned medical device expert will focus on broadening the company’s strategic scope and driving its next phase of growth. OrphaCare plays a key role in supporting AOP Health’s integrated therapies approach, and the Group’s long-term expansion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429303533/en/ Portrait Andreas Goppelt, Managing Director OrphaCare (copyright: AOP Health/Studio Koekart) Andreas Goppelt brings more than 25 years of leadership experience across MedTech, biotechnology and the pharmaceutical industry. He has a proven track record of driving innovation, scaling global organizations, and delivering growth in highly regulated healthcare environments. In his new role,
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