REGimmune is set to become the first Japanese biotech company to be listed in Taiwan. The company aims to enter the over-the-counter (OTC) market in the first half of 2026. Chief Operating Officer Steve Yang stated on the 22nd that REGimmune’s immunomodulatory drug for graft-versus-host disease (GvHD), RGI-2001, has completed Phase IIb clinical trials at seven leading medical centers in the United States, and Phase III trials are expected to commence in 2026. The Phase IIb results have been officially published in the top international hematology journal Blood.
To advance its presence in the international capital market, REGimmune is initiating a pre-OTC capital increase, targeting a raise of NT$300–360 million at NT$56 per share.
Founded in 2006 in Japan, REGimmune’s largest institutional shareholders are Japanese venture capital firms, including Daiwa, JAIC, and SMBC Venture Capital, accounting for roughly 80% of the company’s funding. Domestic institutional shareholders include BioPhoenix and San-Fu Global, and the current capital increase seeks to attract more Taiwanese investors.
Steve Yang emphasized that REGimmune focuses on novel therapies for immune diseases and cancer. The company’s technology was originally transferred from Japan’s national research institute, RIKEN. Its fastest-progressing product, RGI-2001, began human clinical trials in September 2011, aimed at preventing GvHD in patients receiving allogeneic hematopoietic stem cell transplants. The drug has now completed Phase IIb trials at seven U.S. medical centers and demonstrated excellent safety and preliminary efficacy in early Phase I/IIa trials. REGimmune previously licensed the China Phase III and subsequent commercialization rights of RGI-2001 to San-Fu Chemical.
GvHD is a common and potentially fatal complication for blood cancer patients undergoing allogeneic stem cell transplantation. Current treatments rely heavily on immunosuppressants, which reduce rejection but increase infection and mortality risk. RGI-2001 innovatively uses a liposomal formulation to induce activation and proliferation of regulatory T cells (Tregs), effectively controlling effector T cell (Teff) attacks without globally suppressing the immune system, achieving both safety and efficacy in rejection prevention.
The Phase IIb trial of RGI-2001 enrolled 49 patients, who received weekly doses for six consecutive weeks starting on the day of transplantation. Results showed that the 100-day incidence of all-grade GvHD was 24.9%, and moderate-to-severe GvHD was only 4.1%. At 180 days, GvHD-free survival reached 70.8%, significantly higher than the control group’s 50.7%.
Yang noted that RGI-2001 has received U.S. FDA orphan drug designation, offering high pricing potential with low competition. Approximately 30,000 allogeneic hematopoietic stem cell transplants occur globally each year (around 10,000 in the U.S.), highlighting a substantial unmet need for drugs specifically preventing GvHD. Market analysts estimate the global sales potential of RGI-2001 could reach US$2 billion.
Resource: 首家日本生技股在台掛牌 瑞格拚明年上半年登興櫃
