News Release

•  Taiwan Bio will leverage the Quantum Flex^™ Cell Expansion System 3-in-1 workflow beyond CAR-T to support development of regulatory T-cell therapies
• Program will evaluate simplified, scalable, automated manufacturing aligned with late-stage development and clinical readiness needs

Lakewood, Colorado — March 17, 2026 — Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company and global leader in blood management solutions, has entered into a collaboration with Taiwan Bio Therapeutics Inc. (Taiwan Bio) to transition regulatory T-cell (Treg) manufacturing onto the automated Quantum Flex platform, supporting a move from manual processes toward more scalable, repeatable production.

Taiwan Bio is leveraging the 2025 Nobel Prize-winning discovery of Tregs, which regulate immune tolerance, for the development of the TregCel therapy TRK-001, now in multicenter Phase 2 trials to test its ability to prevent graft rejection in kidney transplantation. Through the new collaboration, the parties will integrate Taiwan Bio’s existing Phase 2 Treg manufacturing platform with Quantum Flex to develop a new process for next-generation engineered Treg manufacturing. The work will build on Terumo BCT’s integrated 3-in-1 protocol, published last year in Cytotherapy,¹ which automates cell activation, viral transduction and cell expansion within a single closed bioreactor, reducing manual handoffs and process variability.

"Manufacturing stability is the bridge between a scientific breakthrough and a viable therapy,” said Wenyan Leong, Director, APAC Commercial Cell and Gene Therapy, Terumo BCT. “By transitioning Taiwan Bio’s Treg programs onto Quantum Flex, we are replacing manual variability with an automated, standardized process designed to perform at both clinical and commercial scale. This collaboration is about establishing a robust operational foundation that allows developers to advance even the most sensitive cell types with confidence."

"As a rare, difficult-to-expand, and inherently unstable cell type, Tregs make manufacturability a defining consideration. Our collaboration with Terumo BCT enables us to move beyond a highly manual workflow and evaluate an integrated, closed manufacturing approach that can improve efficiency and accessibility, reduce COGS [cost of goods sold], and shorten cycle time — accelerating clinical translation across our Treg pipeline,” said Cyrus Yang, CEO of Taiwan Bio.

The companies have begun to evaluate the 3-in-1 workflow’s operational simplicity, manufacturing efficiency and scalability as part of Taiwan Bio’s evolving clinical manufacturing strategy for Treg therapies, planning to complete initial transition and optimization activities in the coming months.

Taiwan Bio will then use the integrated TRK-001 process adapted to Quantum Flex as a foundation to enable next-generation engineered Treg programs, with the goal of advancing at least one next-generation Treg candidate to an Investigational New Drug (IND) application, while the companies plan to pursue joint industry engagement activities in the region.

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Quantum Flex™ is either a registered trademark or trademark of Terumo BCT, Inc. in the United States and/or other countries. See TerumoBCT.com/Trademarks for details.

Product and services are available in selected areas subject to regulatory approval in each country.

¹ Wang Q, Zhou L, Tan L, et al. A 3-in-1 integrated automated platform for rapid CAR-T cell manufacturing: activation, transduction, and expansion in a hollow-fiber system. Cytotherapy. 2025;27(8):1001-1012. doi:10.1016/j.jcyt.2025.05.006

About Taiwan Bio Therapeutics Inc.

Taiwan Bio Therapeutics Inc. was founded in 2014, built on a cell culture technology co-developed by National Yang Ming Chiao Tung University and Taipei Veterans General Hospital to develop novel cell therapies. By integrating this technology with advanced cell engineering, the company aims to enhance the accessibility of cell therapies and drive progress in regenerative medicine.

About Terumo Blood and Cell Technologies

Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees worldwide believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers.

Terumo Blood and Cell Technologies' customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers and private medical practices. Our customers are based in over 160 countries across the globe. We have 750+ granted patents, with more than 150 additionally pending.

We have global headquarters in Lakewood, Colorado, U.S.A., along with four regional headquarters, eight manufacturing sites and seven innovation and development centers across the globe. Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology.