Steminent Biotherapeutics Inc. (SBI) aims to advance the translation of stem cell technology into effective cellular treatments for unmet or underserved medical needs. SBI has established its proprietary AD-MSCs (Adipose-Derived Mesenchymal Stem Cells) technology platform and its standardized stem cell product, Stemchymal®. SBI is one of the global leading stem cell therapy companies in its phase II clinical stage in Taiwan, US and Japan. With unique patented cell properties, Stemchymal® lends itself to safe and efficacious allogeneic use and received Orphan Drug Designation (ODD) for Spinocerebellar Ataxia (SCA) treatment from US Food and Drug Administration and Japan Pharmaceuticals and Medical Devices Agency (Japan ODD is received by licensed Japanese partner).
2009 | Steminent Biotherapeutics Inc.(SBI) was founded. |
2011 | SBI received Taiwan phase I clinical trial approval for SCA treatment. |
2014 | SBI completed the Taiwan phase I clinical trial for SCA treatment. |
2015 | SBI received Orphan Drug Designation for SCA treatment from USFDA. |
2015 | SBI received Taiwan phase I clinical trial approval for osteoarthritis knee treatment. |
2016 | SBI received Taiwan phase II clinical trial approval for SCA treatment. |
2016 | SBI completed the out-licensing with its Japanese partner. |
2018 | SBI received USFDA phase II clinical trial approval for SCA treatment. |
2018 | SBI received Japan PMDA phase II clinical trial approval for SCA treatment. |
2018 | SBI completed the Taiwan phase I clinical trial for osteoarthritis knee treatment. |
2018 | SBI received Taiwan phase I clinical trial approval for ALF treatment. |
2020 | SBI completed the Taiwan phase II clinical trial for SCA treatment and is now processing data analysis; Japan phase II clinical trial for SCA treatment is ongoing;SBI completed the out-licensing with its Korean partner. |
2023 | SBI, with the Japanese partner, completed the Japan phase II clinical trial for SCA treatment. |