[Edaily Reporter KIM JI-WAN ] ViGenCell Inc.(308080)is accelerating its entry into the Japanese regenerative medicine market. The company’s strategy is to pursue global business development by identifying technology transfer partners while also exploring the possibility of direct commercialization through Japan’s local regulatory framework.

ViGenCell Inc. announced on the 7th that it will participate in “BIO JAPAN 2026,” taking place from the 7th to the 9th at Pacifico Yokohama in Yokohama, Japan.

BIO JAPAN, an international event in the biotech sector that began in 1986, is celebrating its 40th anniversary this year. Approximately 1,500 companies from the pharmaceutical, biotech, and healthcare sectors are expected to participate.

During the event, ViGenCell Inc. plans to hold partnering meetings with global pharmaceutical and biotech companies to discuss technology transfer and joint development opportunities for its cell therapy pipeline. In particular, the company views Japan—which has accumulated regulatory, clinical, and commercialization experience in the field of regenerative medicine—as a key market and intends to expand its network of potential partners.

At the center of its business development efforts is the cell therapy “VC-101 (VT-EBV-N),” which targets EBV-positive lymphoma. The company will explore collaboration opportunities with Japanese firms by highlighting the Phase 2 clinical trial results and long-term follow-up data for VC-101.

The results of the Phase 2 clinical trial and four-year follow-up for VC-101 were presented in succession as oral presentations at the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) in 2026. In South Korea, following approval of the treatment plan under the Advanced Regenerative Medicine program, the company began treating and enrolling actual patients last September.

ViGenCell Inc. is positioning its experience—moving beyond the research and development stage to actual clinical practice through clinical trials—as a key differentiator in its strategy to penetrate the Japanese market.

Preparations for entering the Japanese market are also underway. Last September, officials from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) visited South Korea to conduct an on-site inspection of the “V-Cell Center,” ViGenCell Inc.’s in-house cell processing and GMP manufacturing facility. ViGenCell Inc. is exploring ways to commercialize the product by aligning Japan’s regenerative medicine regulations with the clinical data for VC-101.

The company will also introduce its pipeline beyond VC-101. It plans to highlight the manufacturing capabilities of the V-Cell Center—including “VC-302,” currently in development for glioblastoma, and “VC-420” for hepatocellular carcinoma—and seek opportunities for joint development and production partnerships in the cell therapy sector.

ViGenCell Inc. plans to explore both technology transfer and direct market entry simultaneously, without limiting its Japan market entry strategy to any specific approach. The fact that Japan has established institutional pathways to link clinical results in the regenerative medicine field to actual patient treatment is another factor behind the consideration of direct market entry.

Ki Pyeong-seok, CEO of ViGenCell Inc., stated, “VC-101 is a case where the results of a Phase 2 clinical trial and a four-year follow-up were presented at a global academic conference, and it became the first advanced regenerative medicine treatment in Korea to proceed to actual patient administration.” He added, “Our greatest strength is that we possess comprehensive experience spanning from development to the clinical setting, and we believe Japan is the market where that experience is most applicable; therefore, we have been preparing the groundwork for market entry, including an on-site inspection of our manufacturing facilities.”

He added, “To realize the value of VC-101 at an early stage, we will simultaneously pursue multiple avenues, including technology transfer as well as direct market entry utilizing Japan’s advanced regenerative medicine system.”