Taiwan Bio Therapeutics

What Taiwan Bio Therapeutics does

Taiwan Bio Therapeutics Inc. (台寶生醫股份有限公司; Taiwan Emerging Stock Board ticker 6892) is a Taiwan-based clinical-stage cell therapy company founded in 2014 that develops regulatory T-cell (Treg) and mesenchymal stem cell (MSC) products for organ transplant rejection, autoimmune disease, osteoarthritis, and critical limb ischemia. Its core technology is the FAST CGT (Fast Cell and Gene Therapy) platform, a short-process manufacturing architecture integrating big-data analysis, transgene design, cell engineering, gene modification, automated manufacturing, and quality control, supported by a proprietary Treg-specific big-data database co-developed with Harvard University. The lead clinical asset is TregCel/TRK-001, an allogeneic Treg therapy currently in FDA- and TFDA-approved Phase 2 trials in Taiwan and the US (34 patients planned) for kidney transplant rejection, with FDA Orphan Drug Designation and the first US patient infused at Northwestern Memorial Hospital in October 2025; Chondrochymal® is an allogeneic bone marrow MSC therapy in TFDA-approved Phase 3 for knee osteoarthritis (222 patients); Biochymal (MSC/VEGF) has submitted an IND to the FDA for critical limb ischemia. The company also operates a TDM (Therapeutics Design & Manufacturing) CDMO service providing 'needle-to-needle' support to preclinical and early-clinical cell therapy developers, automated through Terumo BCT's Quantum Flex closed bioreactor system. Business model combines pre-commercial proprietary drug development (future licensing, royalties, and direct sales) with current CDMO service revenue (NT$105M in 2024, a historical high) and milestone/royalty income from out-licensing arrangements such as the (now terminated) Senectus Chondrochymal license. The company serves hospitals and academic medical centers (Mayo Clinic, Brigham and Women's Hospital/Harvard, Northwestern, NTU Hospital, Taichung Veterans General, Linkou Chang Gung, Cheng Kung University Hospital) as clinical trial sites, and biotech clients as TDM/CDMO customers, with US operations run through wholly-owned subsidiary Singulera Therapeutics and Taiwan Bio Holding LLC.

Name

Taiwan Bio Therapeutics

Legal name

台寶生醫股份有限公司 (Taiwan Bio Therapeutics Inc.)

Website

https://twbio-thera.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Taiwan Bio Therapeutics is a Taiwan-based clinical-stage cell therapy company developing regulatory T-cell (TregCel/TRK-001) and mesenchymal stem cell (Chondrochymal®, Biochymal) therapies for transplant rejection, autoimmune disease, osteoarthritis, and ischemia, serving hospitals and biotech clients via its FAST CGT platform and TDM CDMO services.

Ownership category

akta.pro rank

Product category

Cell Therapy Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)

akta.pro secondary industries

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Transplantation & Advanced Therapies Pharmaceuticals (incl. Cell & Gene Therapies) (HLAIAAAO), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)

Keywords

• Cell therapy development
• Regenerative medicine
• Stem cell therapy
• Contract development manufacturing
• Biopharmaceutical products

Headquarters

HQ city

Hsinchu

HQ country

Taiwan

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Supply Chain, Marketing or Sales

Revenue model

1. Proprietary Drug Development and Sales: Revenue from proprietary cell therapy drug pipeline including TregCel/TRK-001 (Phase 2 for kidney transplant rejection), Chondrochymal (Phase 3 for knee osteoarthritis), and Biochymal (Phase 1 for critical limb ischemia). Revenue will be generated upon regulatory approval and commercialization. Currently pre-revenue as all products are in clinical development.
2. TDM (Therapeutics Design & Manufacturing) CDMO Services: Contract development and manufacturing services for preclinical and early clinical stage cell therapy products. TDM model provides 'needle-to-needle' services from R&D to manufacturing for third-party cell therapy companies. Revenue from service fees. 2024 full-year consolidated revenue was approximately NT$105 million, a historical high, driven by TDM/CDMO business growth.
3. Technology Licensing and Royalty: Revenue from out-licensing proprietary technology and manufacturing rights. Previously licensed Chondrochymal to Senectus for Asia-Pacific development (now terminated). Receives milestone payments and potentially sales royalties from licensing partners. Also supplies clinical-grade cell products to partners at fixed prices.
4. Exosome/Ingredient Sales: Revenue from selling exosome raw materials. Human Umbilical Wharton's Jelly Mesenchymal Stem Cell Extracellular Vesicles received INCI certification (PCPC, certification #40181), enabling legal sale in global cosmetics and skincare markets.

Go-to-market motion1 record

Distribution channels5 records

Marketing channels5 records

Core offering

Taiwan Bio Therapeutics develops and clinically advances allogeneic cell therapy products (TregCel/TRK-001 for kidney transplant rejection, Chondrochymal® for knee osteoarthritis, Biochymal for critical limb ischemia, and an INCI-certified exosome ingredient for cosmetics) using its proprietary FAST CGT short-process manufacturing platform, and concurrently monetizes the platform by providing TDM (Therapeutics Design & Manufacturing) contract development and manufacturing services to preclinical and early clinical-stage cell therapy developers.

Product overview

Taiwan Bio Therapeutics is a cell therapy company developing a portfolio of regulatory T-cell (Treg) and mesenchymal stem cell (MSC) therapies. The company's core offering is the FAST CGT manufacturing platform, which enables accelerated and cost-reduced cell therapy production. Key products include TregCel (TRK-001) for transplant rejection prevention (Phase 2), Chondrochymal® for knee osteoarthritis (Phase 3), and Biochymal for critical limb ischemia. The company operates through its US subsidiary Singulera and offers contract manufacturing services via its TDM business model. The portfolio is supported by the FAST CGT technology platform incorporating big data analytics and AI-driven clinical trial design.

Differentiator

Problem solved

Functional benefit

Brands

• Chondrochymal®: Allogeneic mesenchymal stem cell product for knee osteoarthritis treatment
• Biochymal
• TregCel (TRK-001)
• TDM (Therapeutics Design and Manufacturing)
• FAST CGT Platform

Products and services

• TregCel (TRK-001) Allogeneic regulatory T-cell (Treg) cell therapy designed to prevent kidney transplant rejection by inducing immune tolerance as a single-treatment alternative to lifelong immunosuppressants; in Phase 2 clinical trials at US (Mayo Clinic Rochester/Phoenix, Northwestern Memorial) and Taiwan (NTU Hospital, Taichung VGH, Cheng Kung University, Linkou Chang Gung) sites.
• Chondrochymal® Branded allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy administered via intra-articular injection for knee osteoarthritis as a disease-modifying alternative to painkillers and joint replacement; currently in TFDA-approved Phase 3 clinical trials.
• Biochymal (MSC/VEGF) Allogeneic gene-modified mesenchymal stem cell therapy expressing vascular endothelial growth factor (VEGF), intended for treatment of critical limb ischemia through tissue repair and angiogenesis; in preclinical/Phase 1 stage with FDA IND submitted.
• Exosome Raw Material (Human Umbilical Wharton's Jelly MSC Extracellular Vesicles) Human Umbilical Wharton's Jelly Mesenchymal Stem Cell Extracellular Vesicles sold as an INCI-certified (PCPC #40181) bioactive raw material for cosmetics and skincare product manufacturers globally.
• TDM (Therapeutics Design & Manufacturing) Services Contract development and manufacturing organization (CDMO) service providing preclinical and early clinical-stage cell therapy companies with full 'needle-to-needle' support — from mechanism of action research and cell product design to multi-station automated production — using the FAST CGT platform; delivered from Taiwan Bio's Zhubei GMP facility and drove 2024 record consolidated revenue of NT$105 million (~US$3.2 million).

Quantifiable outcome

• Chondrochymal Phase 2: 29.85-point WOMAC pain score improvement at week 24; statistically significant关节结构 improvement vs hyaluronic acid (WORMS p=0.0325); VAS pain score significantly better than control at week 24 (p=0.0442); WOMAC stiffness significantly better at week 24 (p=0.0321)
• +3 more outcomes

Named customers8 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature5 records

Partnerships

Eight partnerships are on record, tiered core, supporting, minor and major.

• Terumo Blood and Cell Technologies (Terumo BCT)coreTechnology or Integration · 17 March 2026Partnership to transition Treg manufacturing onto Terumo's automated Quantum Flex platform, integrating cell activation, viral transduction, and expansion within a closed bioreactor system. Aims to reduce cost of goods sold, shorten cycle times, and support next-generation engineered Treg programs targeting IND filing. Taiwan Bio's TregCel therapy (TRK-001) will be adapted to this 3-in-1 workflow. Initial transition and optimization expected within the coming months.
• Brigham and Women's Hospital (BWH), Harvard Medical SchoolcoreStrategic or Co-development Partner · 16 March 2026Three-year research collaboration agreement (signed March 2026) with BWH for developing gene-modified Treg technologies to enhance Treg stability and functionality. Follows prior research collaboration whose results were published in Nature Immunology. Dr. Peter Sage (BWH/Harvard, also Taiwan Bio scientific advisor) leads the collaboration. Goal: engineered Treg targeting autoimmune diseases, with IND filing target 2027, Phase 1 trial using basket trial design with AI-powered tools.
• Terumo Blood and Cell Technologies APAC C&GT Ecosystem BlueprintsupportingStrategic or Co-development Partner · 5 March 2026Taiwan Bio is a regional partner in Terumo BCT's Cell & Gene Therapy Ecosystem Blueprint for APAC, addressing fragmented workflows, high costs, and skill shortages to enable scalable, compliant cell therapy operations across the Asia-Pacific region.
• TRACT Therapeutics, Inc. (merged into Singulera Therapeutics Inc.)coreStrategic or Co-development Partner · 1 August 2025Acquired 100% of TRACT Therapeutics for USD 3.5M cash (signed August 2025, completed September 2025). TRACT held TregCel technology and global commercialization rights for TRK-001. Post-acquisition, TRACT (renamed Singulera Therapeutics Inc.) merged with PhiBio Therapeutics Inc., with Singulera as surviving entity. Acquired company contributed complete Treg technology patent portfolio.
• Mayo CliniccoreStrategic or Co-development Partner · 1 May 2025Strategic partnership including Phoenix Innovation Hub (signed LOI May 2025, Term Sheet July 2025), investment (Mayo Clinic holds 8% of Singulera via technology-in-kind), CAR-Treg technology license (α4β7 CAR-Treg, May 2025), clinical trial collaboration (TRK-001 Phase 2 at Rochester and Phoenix campuses). Phoenix hub to include PD lab with FAST CGT platform and TDM model, combining Mayo's clinical resources with Taiwan Bio's manufacturing technology.
• Senectus Pte. Ltd. (Singapore)minorChannel Partner/ Reseller/ Distributor · 30 March 2025Licensed Chondrochymal for Asia-Pacific development and commercialization (December 2024). Senectus exercised license option March 2025, paying >USD 30M to obtain manufacturing rights, with Taiwan Bio holding Senectus equity and board seat. Contract terminated March 2026 due to Senectus funding delays and clinical timeline disagreements. Taiwan Bio retains full development and commercialization rights.
• Johns Hopkins University School of MedicinemajorStrategic or Co-development Partner · 1 December 2024Collaborated via the 2025 Treg Symposium. Dr. Jordan Green from Johns Hopkins participated in Taiwan Bio's Treg Symposium 2025, discussing Treg science and clinical translation. Represents academic collaboration network spanning Harvard, Mayo Clinic, and Johns Hopkins for Treg cell therapy development.
• Northwestern Memorial HospitalmajorStrategic or Co-development Partner · 1 April 2024Clinical trial site for TRK-001 Phase 2 kidney transplant rejection trial. Completed first US patient enrollment and cell infusion in October 2025, marking first US clinical milestone for the Treg program.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Sonoma Biotherapeutics: Clinical-stage Treg cell therapy company developing engineered regulatory T cells for autoimmune diseases including rheumatoid arthritis, inflammatory bowel disease, and type 1 diabetes. Directly comparable to Taiwan Bio's engineered Treg pipeline and CAR-Treg technology from Mayo Clinic.
• Pluristem Therapeutics: Clinical-stage cell therapy company developing allogeneic placenta-derived MSC products for multiple indications including critical limb ischemia. Directly comparable to Taiwan Bio's Biochymal program targeting CLI with gene-modified MSC.
• Quell Therapeutics: UK-based clinical-stage Treg cell therapy company developing therapies for organ transplantation and autoimmune disease. Directly comparable to Taiwan Bio's TRK-001 program as both target transplant rejection with engineered Treg approaches; both are at similar clinical stages.
• Cellares Corporation: Cell therapy manufacturing automation company offering integrated Cell Shuttle platform for cell therapy CDMO services. Directly comparable to Taiwan Bio's TDM CDMO service offering and Terumo BCT Quantum Flex-enabled manufacturing approach.
• Athersys: Clinical-stage cell therapy company developing MultiStem® allogeneic cell therapy for inflammatory, immune, and neurological conditions. Comparable to Taiwan Bio's MSC-based programs and Chondrochymal® approach to inflammatory and degenerative disease treatment.
• Mesoblast: Australian-listed commercial-stage cell therapy company developing allogeneic mesenchymal stem cell (MSC) products. Directly comparable to Taiwan Bio's Chondrochymal® MSC platform and Biochymal gene-modified MSC approach, with both targeting inflammatory and degenerative diseases.

Broad incumbents

• Catalent (Novo Holdings): Major global CDMO with cell therapy manufacturing capabilities serving gene and cell therapy developers. Comparable to Taiwan Bio's TDM CDMO service business at scale, though serving larger commercial-stage clients.
• Adaptimmune Therapeutics: Commercial-stage cell therapy company developing engineered T-cell therapies (SPEAR T-cells) for solid tumors. Broader incumbent in the cell therapy space with overlapping manufacturing and clinical translation expertise comparable to Taiwan Bio's FAST CGT platform.
• Lonza Group: Global contract development and manufacturing organization (CDMO) with a major cell and gene therapy manufacturing business. Larger incumbent in the cell therapy CDMO space directly comparable to Taiwan Bio's TDM service model in scale and scope.

Emerging players

• Sangamo Therapeutics: Clinical-stage cell and gene therapy company developing genomic medicines including engineered cell therapies for autoimmune disease. Comparable emerging player with overlapping gene-editing and engineered cell therapy approaches relevant to Taiwan Bio's engineered Treg platform.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/taiwan-bio-therapeutics-co-ltd

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries2 records

Funding overview

Funding rounds1 record

Investors1 record

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M&A

Investments

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Frequently asked questions about Taiwan Bio Therapeutics