Taipei, July 6, 2023 – REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, today appointed Hua Nan Securities as the lead underwriter for its upcoming initial public offering (IPO) in Taiwan. The IPO is anticipated to take place in 2025, signifying an important milestone in REGiMMUNE’s expansion and entry into the Taiwanese financial market.
REGiMMUNE Limited’s core technology stems from Riken, a renowned national research institute based in Japan. Our main area of concentration revolves around pioneering immunotherapies that regulate regulatory T cells, also known as Tregs. In 2006, we were founded in Japan, and subsequently REGiMMUNE group has reorganized its Taiwanese entity, REGiMMUNE Limited, to become the holding company for the entire group, and now owns 100% of REGiMMUNE Corporation, its Japanese subsidiary, and REGiMMUNE Inc, its U.S. subsidiary. Our company’s fundamental philosophy, “From Care to Cure for Immune Disorders,” highlights our commitment to not only the care of immune diseases but also their cure.
REGiMMUNE Limited provides innovative therapeutic solutions to patients with autoimmune diseases and cancer through its reVax technology platform and antibody drugs. The lead program, RGI-2001, has the potential to be a first-in-class small molecule drug for preventing acute graft-versus-host disease (aGvHD), a fatal complication of allogeneic hematopoietic stem cell transplantation that results in rejection, by enhancing current therapeutic approaches with a novel mechanism. RGI-2001 was selected for oral presentation at the American Society of Hematology (ASH) annual meeting in December 2022 and is planned to be submitted to the FDA for Phase III IND and begin discussions on Fast Track Designation and Breakthrough Therapy Designation, which will be awarded to breakthrough drugs. In the final quarter of 2023, with clinical trials scheduled to commence in the third quarter of 2024.
In March 2023, a licensing agreement regarding RGI-2001 was signed between REGiMMUNE and SanFu Biotech, which is a subsidiary of SanFu Chemical Group. This agreement grants SanFu Biotech the exclusive rights to develop and commercialize RGI-2001 in Asia. SanFu Biotech is considered a valuable strategic partner by REGiMMUNE in the Asian market due to their extensive resources in the biotechnology and biomedical sectors, as well as its exceptional innovative strategies. REGiMMUNE is excited to collaborate with SanFu Biotech to accelerate the progress of RGI-2001 in this significant market.
Taiwan’s biomedical sector boasts a robust clinical trial infrastructure, favorable access to capital markets, extensive research and development capabilities, and a vast human biological database. With steadfast government backing, Taiwan has established itself as a leader in Asia’s biotechnology and medical sector. REGiMMUNE is committed to harnessing Japan’s proficiency in fundamental research and Taiwan’s complete industrial ecosystem in applied research and development to maximize the commercial potential of fundamental research and foster mutually beneficial business opportunities. We are thrilled to partner with Taiwan’s biotech industry to explore the global market and aspire to become the first Japanese novel drug research firm to be listed in Taiwan and embody Taiwan-Japan collaboration in the biotech field, with the support of the officers and colleagues at all levels in Hua Nan Securities.
RGI-2001 is a liposomal injection formulation of an alpha-galactosylceramide (alpha-GalCer) analog. Alpha-GalCer binds to the CD1d receptor of antigen-presenting cells resulting in activation of invariant natural killer (iNKT) cells, resulting in the activation and expansion of regulatory T cells (Tregs), thus establishing immune tolerance. RGI-2001 is REGiMMUNE’s lead drug candidate, currently in Phase 3 planning for the prophylaxis of acute graft-versus-host disease (aGVHD).
About REGiMMUNE Limited
REGiMMUNE is a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies by harnessing the power of regulatory T cells (Tregs). REGiMMUNE is creating a pipeline of novel product candidates that either enhance Treg activities for immune diseases or suppress Treg activities for cancer.
Chief Financial Officer
+886 2 2555 3377 #511
2023年7月6日，台北 – 專注於自體免疫疾病與癌症，開發創新免疫療法之生技公司 – 瑞格國際生技今日宣佈與華南永昌證券簽訂上市櫃輔導契約，預計於2025年掛牌，開啟邁向臺灣資本市場旅程。
瑞格之核心技術源於日本國家級研究機構 – 理化學研究所，亦稱為Riken。瑞格藉由技術平台reVax (Reverse Vaccination)調控調節性T細胞(Regulatory T cells, Tregs)，開發創新之免疫療法。2006年於日本設立，2018年重組控股架構，在臺灣設立瑞格國際生技，下轄全資子公司日本瑞格生技及孫公司美國瑞格生技。我們關鍵理念為”From Care to Cure for Immune Disorders”，亦即我們的訴求不僅止於照護，而是冀望治癒因免疫系統失衡造成的疾病。
瑞格藉由reVax技術平台以及抗體藥物，提供創新的治療方案予自體免疫疾病及癌症病患。候選藥物RGI-2001以全新的藥物機轉改善現有治療方式，有濳力成為急性移植物抗宿主疾病(aGvHD)預防之臨床首創機制(First-in-Class)小分子新藥，移植物抗宿主疾病是異體造血幹細胞移植引起排斥反應的致命併發症。RGI-2001已完成在美國執行的第二期臨床試驗，療效與安全性結果均呈屬正面，2022年12月獲選於美國血液學會(ASH)年會口頭發表臨床試驗成果；規劃於2023年第4季向美國FDA申請第三期人體臨床試驗審查(IND)，並討論申請快速通道(Fast Track)及突破性療法(Breakthrough Therapy)的可行性，計劃於2024年第3季開始臨床人體試驗收案。
RGI-2001係為α-半乳糖神經醯胺(α-Galactosylceramide, α-GalCer)之脂質體注射製劑，α-GalCer與抗原呈遞細胞(Antigen Presenting Cells)上之CD1d配體結合，透過活化恆定自然殺手T細胞(iNKT)，近一步活化並擴增調節性T細胞，建立免疫耐受性。RGI-2001為瑞格國際生技主要之候選藥物，聚焦急性移植物抗宿主疾病(aGvHD)之預防，將規劃開展第三期臨床試驗。
許育誠 (Charlie Hsu)
+886 2 2555 3377 #511