On the 22nd, Hsu-Sung Kuo, Chairman of Taiwan Bio Therapeutics, announced that the company's management team is fully prepared to seize the opportunities presented by favorable domestic and international policies. The company aims to accelerate its entry into the global market using a three-pronged strategy. Taiwan Bio Therapeutics is determined to establish itself as an international cell therapy company with proprietary technology, financial stability, and regulatory expertise. Additionally, the company plans to integrate AI and automation technologies to secure global contracts for cell therapy CDMO (Contract Development and Manufacturing Organization) services, ensuring sustainable operations and steady growth.
In June of this year, Taiwan Bio Therapeutics held its shareholders' meeting, where the entire board was re-elected. Following the election, Hsu-Sung Kuo, former president of Yang-Ming University, was appointed as chairman. The company aims to leverage his extensive domestic and international medical resources to bring new vitality to the management team. On the 22nd, Hsu-Sung Kuo, in his first public statement as chairman, outlined the company’s future business direction.
Kuo emphasized that Taiwan's implementation of dual laws for regenerative medicine provides a clear legal foundation for cell and gene therapy products, facilitating alignment with international standards. Furthermore, the U.S. BIOSECURE Act, which accelerates the decoupling from China, has prompted major international CDMO companies to expand their operations in the U.S. to fill the supply chain gaps left by Chinese manufacturers. This shift presents a golden opportunity for Taiwan Bio Therapeutics, which plans to expand its presence in the U.S. market starting this year.
Kuo stated that he and CEO Cyrus Yang will work together to enhance Taiwan Bio Therapeutics' international visibility, leading the team with three key strategies to expand globally and open new opportunities.
First, Taiwan Bio Therapeutics has officially entered the field of immunological diseases. The company’s TregCel (TRK-001), a regulatory T-cell therapy developed in collaboration with U.S. partner TRACT, has received FDA approval to proceed with Phase II clinical trials. Taiwan Bio Therapeutics has also applied to Taiwan's TFDA for a Phase II trial, targeting kidney transplant rejection. This initiative will involve multi-country, multi-center clinical trials. Additionally, their collaboration with Harvard University on gene-modified regulatory T-cells has made significant progress, with advanced process design for regulatory T-cell production underway.
Second, leveraging the groundwork laid over the past six months in collaboration with Taichung Veterans General Hospital, Taiwan Bio Therapeutics is actively promoting end-to-end integrated CDMO services, creating a cell therapy technology ecosystem.
Cyrus Yang emphasized that the development of cell therapy products, from basic research to clinical trials, or from obtaining raw cells to delivering the product back to the correct patient, requires close collaboration with hospitals. Taiwan Bio Therapeutics' new business model, established with Taichung Veterans General Hospital, has already shown initial success and will be replicated in the U.S. market to tap into the vast regenerative medicine opportunities.
Lastly, Taiwan Bio Therapeutics is advancing a "decentralized" production model, while emphasizing centralized R&D and process development. The company is also integrating automation with AI-based image recognition technologies to create a unique CDMO and process development platform, aiming to capture greater commercial value. To this end, Taiwan Bio Therapeutics has partnered with Streamline Bio, a U.S. company founded by Harvard University expert Yu-Shun Hsiao, to introduce new technologies that accelerate the automation of cell therapy production.
Yang explained that traditional pharmaceutical manufacturing often adopts a centralized approach to reduce production costs. However, given the unique characteristics of cell therapy products, decentralization involves establishing regional production hubs around medical centers to shorten the distance between clinical and manufacturing sites, thus creating a simplified and resilient supply chain.
Yang further noted that due to the complexity of cell therapy products, automated production is necessary to avoid human error. In the future, GMP facilities will collaborate with Streamline Bio to incorporate robotic arms equipped with AI image recognition and path planning functions, replacing manual labor in clean rooms. This approach will optimize production processes, enhance scalability, improve quality standards, and reduce overall costs.
The innovative combination of AI and robotic technology can solve previous issues where robotic arms were unable to handle soft tubes and bags on cell therapy production lines. Streamline Bio's proprietary plug-and-play solution integrates seamlessly into the CDMO field for cell therapy. Taiwan Bio Therapeutics will become the first biotech company globally to adopt this technology, using automated production lines to address the heavy reliance on manual labor and low production quality stability in cell therapy manufacturing. This move will further realize true decentralized production in the future.
Resource (mandarin): 台寶生醫鏈結國內外資源 三箭齊發進軍國際市場
