SEOUL -- 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.