Taiwan Bio Therapeutics is a regenerative medicine company focused on developing cell therapies as drug products. To date, two candidates in its pipeline have entered Phase IIb clinical trials (Chondrochymal for knee osteoarthritis and Biochymal for wound healing in patients with critical limb ischemia). With its PIC/S GMP-compliant Cell Processing Center, Taiwan Bio also offers contract development and manufacturing (CDMO/CMO) services as well as customized assay development and testing services for cell products.
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 |