2025/09/18
Editorial Column
Taiwan Exosome Company has established the first domestic clinical-grade universal (non-matching and non-genetically modified) NK cell platform, possessing the key capability to enter clinical trials. This became the decisive factor for Toyota Holdings Co
Taiwan Exosome Co., Ltd.
Taiwan Exosome Co., Ltd. has established the nation’s first clinical-grade universal (non-matching and non-gene-modified) NK cell platform, possessing the critical capabilities necessary to advance into clinical trials. This was the decisive factor behind Toyota Holdings Corporation selecting the company as a partner.
The company’s NK cell manufacturing facility is the first in Taiwan and the sixth worldwide capable of providing a clinical-grade, universal, non-matching, and non-gene-modified NK cell platform.
This milestone demonstrates that Taiwan Exosome possesses the comprehensive capabilities to support clinical research and immunotherapy validation, thereby helping Taiwan’s cell therapy industry further expand international collaboration opportunities.
Regulatory Advantage Driving Regenerative Medicine
Since the implementation of the “Regulations on the Implementation or Use of Specific Medical Technology, Examination, and Medical Devices” in 2018, Taiwan has become the second country in the world to conditionally open up cell therapy.
Currently, more than 60 companies are engaged in the regenerative medicine field. Among them, Taiwan Exosome is the first to obtain a clinical-grade universal (non-matching and non-gene-modified) NK cell platform in Taiwan, with comprehensive capabilities spanning clinical-grade manufacturing, quality control, and trial planning.
Long-Term Platform Development through a “Dual-Track Integration × Three-Arrows Strategy”
Taiwan Exosome is building on two core platforms:
Immune cell manufacturing platform
Exosome research and development platform
These span three major sources:
Plants
Animals
Humans
Through this, the company is creating an expandable, modular exosome technology platform with applications across:
Health product development
Biotechnology research
Clinical technology validation
By placing integrated technology at its core, Taiwan Exosome connects basic research to industrial applications, aiming to become an innovative platform with strong international collaboration potential.
Clinical Collaboration: Technology Validation and Data Collection
Currently, Taiwan Exosome is collaborating with the following medical institutions:
Linkou Chang Gung Memorial Hospital
National Cheng Kung University Hospital
The company provides autologous or universal NK cell products for clinical technology validation and data collection.
All research processes comply with:
The Taiwan Food and Drug Administration (TFDA) regulations
Institutional Review Board (IRB) reviews
This ensures adherence to regulatory and ethical requirements.
Precise Entry into High-Growth Markets
According to Global Market Insights:
🔹 NK cell applications market: Projected to reach a compound annual growth rate (CAGR) of 43.1% by 2030
🔹 Exosome market: Forecasted to exceed USD 4.37 billion by 2037
Both represent industries with high technological barriers and strong growth potential. Through its strategy of “Diverse R&D × Clinical Linkage,” Taiwan Exosome is steadily enhancing its international visibility and partnership opportunities.
Looking Ahead: Connecting with the Global Innovation Ecosystem
Dr. Chieh-Liang Lin, Chief Operating Officer and Chief Technology Officer of Taiwan Exosome, stated:
“The establishment of Taiwan’s first clinical-grade universal (non-matching and non-gene-modified) NK cell platform marks an important milestone in our technological strategy, demonstrating our integrated capabilities in manufacturing, research and development, and clinical translation.
Moving forward, we will continue to deepen collaborations with international clinical institutions, accelerate application research in exosome and immune cell platforms, and further strengthen Taiwan’s global participation in the regenerative medicine field.”
Taiwan Exosome Co., Ltd. has established the nation’s first clinical-grade universal (non-matching and non-gene-modified) NK cell platform, possessing the critical capabilities necessary to advance into clinical trials. This was the decisive factor behind Toyota Holdings Corporation selecting the company as a partner.
The company’s NK cell manufacturing facility is the first in Taiwan and the sixth worldwide capable of providing a clinical-grade, universal, non-matching, and non-gene-modified NK cell platform.
This milestone demonstrates that Taiwan Exosome possesses the comprehensive capabilities to support clinical research and immunotherapy validation, thereby helping Taiwan’s cell therapy industry further expand international collaboration opportunities.
Regulatory Advantage Driving Regenerative Medicine
Since the implementation of the “Regulations on the Implementation or Use of Specific Medical Technology, Examination, and Medical Devices” in 2018, Taiwan has become the second country in the world to conditionally open up cell therapy.
Currently, more than 60 companies are engaged in the regenerative medicine field. Among them, Taiwan Exosome is the first to obtain a clinical-grade universal (non-matching and non-gene-modified) NK cell platform in Taiwan, with comprehensive capabilities spanning clinical-grade manufacturing, quality control, and trial planning.
Long-Term Platform Development through a “Dual-Track Integration × Three-Arrows Strategy”
Taiwan Exosome is building on two core platforms:
Immune cell manufacturing platform
Exosome research and development platform
These span three major sources:
Plants
Animals
Humans
Through this, the company is creating an expandable, modular exosome technology platform with applications across:
Health product development
Biotechnology research
Clinical technology validation
By placing integrated technology at its core, Taiwan Exosome connects basic research to industrial applications, aiming to become an innovative platform with strong international collaboration potential.
Clinical Collaboration: Technology Validation and Data Collection
Currently, Taiwan Exosome is collaborating with the following medical institutions:
Linkou Chang Gung Memorial Hospital
National Cheng Kung University Hospital
The company provides autologous or universal NK cell products for clinical technology validation and data collection.
All research processes comply with:
The Taiwan Food and Drug Administration (TFDA) regulations
Institutional Review Board (IRB) reviews
This ensures adherence to regulatory and ethical requirements.
Precise Entry into High-Growth Markets
According to Global Market Insights:
🔹 NK cell applications market: Projected to reach a compound annual growth rate (CAGR) of 43.1% by 2030
🔹 Exosome market: Forecasted to exceed USD 4.37 billion by 2037
Both represent industries with high technological barriers and strong growth potential. Through its strategy of “Diverse R&D × Clinical Linkage,” Taiwan Exosome is steadily enhancing its international visibility and partnership opportunities.
Looking Ahead: Connecting with the Global Innovation Ecosystem
Dr. Chieh-Liang Lin, Chief Operating Officer and Chief Technology Officer of Taiwan Exosome, stated:
“The establishment of Taiwan’s first clinical-grade universal (non-matching and non-gene-modified) NK cell platform marks an important milestone in our technological strategy, demonstrating our integrated capabilities in manufacturing, research and development, and clinical translation.
Moving forward, we will continue to deepen collaborations with international clinical institutions, accelerate application research in exosome and immune cell platforms, and further strengthen Taiwan’s global participation in the regenerative medicine field.”