Member Profile
Taiwan Bio Therapeutics Inc.
- Steve Kuo
- 2014/07/25
- 6892
- USD 100,000,000.0
- +886-3-668-4788
- 4F., No. 66, Shengyi 2nd Rd., Zhubei City, Hsinchu County 302041, Taiwan (R.O.C.)
- Cardiology/Vascular Diseases
- Endocrinology/Metabolic Disorders
- Immunology
- Nephrology
- Neuroscience
- Knee Osteoarthritis
- Solid organ transplant
- Regenerative Medicine
- Technology Platform
CERTIFICATE OF GOOD MANUFACTURING PRACTICE (GMP)
- 2015 Taipei Biotech Awards-Technology Transfer Special Mention Award
- 2015 Innovation of the Year Award to the Biothech Industry
Taiwan Bio Therapeutics is a regenerative medicine company specializing in the development of new drugs for cell therapy. The company has successfully advanced a product to Phase III clinical trials (Chondrochymal for the treatment of knee osteoarthritis) and two products to Phase II clinical trials (TregCel for treating immune rejection after organ transplantation and Biochymal for the treatment of difficult wound healing in lower limb ischemia). Taiwan Bio also utilizes its state-of-the-art cell therapy preparation and processing center, built in compliance with PIC/S GMP standards, and its ample production capacity to offer contract development and manufacturing (CDMO/CMO) services for cell product process development. Additionally, it provides cell therapy testing development and contract testing services, having successfully completed the PIC/S GMP inspection.
Product Pipelines
Company Milestones
| 2014 | The business license was acquired, and the actual receipt capital was NT$48,000,000. |
| 2014 | The contact of mesenchymal stem cells technology was signed and transferred from the Taipei Veterans General Hospital and National Yang-Ming University. |
| 2014 | The phase 1/2a clinical trial for the critical limb ischemia was started. |
| 2015 | Subsidized the Angel Project Fund by the National Development Fund. |
| 2015 | Obtained Biotech Innovation of the Year Award from the BioTaiwan 2015. |
| 2015 | Obtain 2015 Technology Transfer Cooperation Award. |
| 2015 | Obtain the subsidy of R&D Organization Technology Development Program from the Ministry of Economic Affairs. |
| 2016 | The patent of preparation of cell transplant in China was gained, which cooperated with the Taipei Veterans General Hospital. |
| 2016 | Become a qualified biotechnology therapeutics company by the Industrial Development Bureau. |
| 2017 | The phase 1/2a clinical trial for the Osteoarthritis was started. |
| 2017 | The phase 1/2a clinical trial for the lower limb ischemia patients enrollment and data analysis was completed. |
| 2019 | The clinical study report of the phase 1/2a clinical trial for the lower limb ischemia patients was approved by Ministry of Health and Welfare. |
| 2019 | The phase 1/2a clinical trial for the osteoarthritis patient enrollment was completed. |
| 2020 | The CSR of phase 1/2a clinical trial for the osteoarthritis was submitted to TFDA. |
| 2020 | A phase I/IIa clinical study of treatment for knee osteoarthritis by intra-articular injection of allogeneic bone marrow derived mesenchymal stem cells was approved by TFDA. |
| 2020 | Purchased a cell preparation center for cell therapy at a price of NT$150 million |
| 2021 | A phase IIb clinical study of treatment for knee osteoarthritis by intra-articular injection of allogeneic bone marrow derived mesenchymal stem cells was approved by TFDA. |
| 2021 | Licensed the CMC of the BMMSC cell bank and phase I IND of AMI treatment by BMMSC technology from ITRI |
| 2022 | A phase IIb clinical trial for the lower limb ischemia patients was approved by TFDA |
| 2022 | Registered on pioneer stock board |
| 2024 | The treatment of knee osteoarthritis through intra-articular injection of allogeneic bone marrow mesenchymal stem cells has passed the (PIC/S) GMP inspection. |