[Edaily Reporter Na Eun-kyung] #ChaBioTech announced on the 19th that it has launched the “Matica K-IIT Program” in collaboration with its U.S. subsidiary, Matica Biotechnology (Matica Bio), targeting cell and gene therapy (CGT) development companies.

This program is a service designed to support U.S.-based biotech companies in evaluating their cell and gene therapy candidates through investigator-initiated trials (IITs) in South Korea. Its goal is to secure early-stage clinical data by linking U.S. manufacturing capabilities with South Korea’s clinical infrastructure.

Investigator-initiated trials are clinical trials led by researchers at medical institutions and are used as a means to obtain early efficacy and safety data. In the cell and gene therapy industry, it is common for companies to use early clinical data to attract follow-up investment or pursue technology transfers.

The Matica K-IIT program is a model that combines Matica Bio’s process development and manufacturing capabilities with Cha Bio Group’s hospital network. The company plans to conduct investigator-initiated trials by establishing a collaborative framework with domestic university hospitals, including Bundang Cha Hospital.

Cha Biotech believes that, given that some U.S. biotech companies are currently conducting early-stage clinical trials overseas, linking U.S. manufacturing with clinical trials in Korea could serve as an alternative in terms of shortening development timelines and improving clinical operational efficiency.

The company also explained that South Korea is gaining attention as a destination for investigator-initiated clinical trials in the cell and gene therapy sector, as it possesses global competitiveness in terms of Good Clinical Practice (GCP) standards and research infrastructure.

Paul Kim, CEO of Matica Bio, stated, “By combining Korea’s clinical trial capabilities with Matica Bio’s CGT manufacturing capabilities, we will safely and efficiently support our clients from early-stage research through global clinical trials.” He added, “We plan to actively introduce the ‘Matica K-IIT Program’ during meetings with global clients at ‘Bio USA,’ the world’s largest biotech event, and devote our full efforts to identifying new business opportunities.”