Milestone
2025
1. 2025/02 auniGEL Hydrogel Wound Dressing Obtains Class II Medical Device Marketing Authorization. (TFDA Medical Device Registration No.: 008424)
2. 2025/04 Collaborating with Tri-Service General Hospital to apply for cell therapy technology under the "Regulations of Special Medical Techniques." (Allogeneic fibroblast therapy for surgical partial-thickness wound)
2024
1. Approved by JIRB, established human umbilical cord-derived mesenchymal stem cell (UC-MSC) banks and human umbilical vein endothelial cell (HUVEC) banks that meet donor eligibility criteria.
2. Approved by JIRB, established human foreskin fibroblast (HFF) banks that meet donor eligibility criteria.
2023
Clinical trial for "Donor Site Wounds" received MOHW's approval for completion.
2022
1. 2022/08 Clinical trial for "Lower Limb Ulcers" passed MOHW's GCP Inspection.
2. 2022/12 Clinical trial for "Lower Limb Ulcers" received MOHW's approval for completion.
2021
Clinical trial for "Donor Site Wounds" passed MOHW's GCP Inspection.
2019
TFDA IND Approval received for phase I clinical trial in "Lower Limb Ulcers."
2018
Phase II enrollment for the "Donor Site Wounds" study has begun.
2017
1. Completed phase I clinical trial – TWB-103 for “Donor Site Wounds”, in Taiwan.
2. Awarded the 14th National Innovation Award for Advanced Bioactive Wound Dressing.
2016
FDA, TFDA and PMDA IND approvals received for Phase I/II clinical trial in "Donor Site Wounds."
2015
The first batch of “TWB-103” has been manufactured in the cell factory of ITRI, Taiwan.
2012
Signed the “Licensing Agreement” with CHUV/Elanix Inc. (Switzerland)
2010
Transwell Biotech was founded and registered in Taipei, Taiwan.