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 Adipose-Derived Mesenchymal Stem Cells technology platform, Stemchymal®, and is one of the global leading stem cell therapy companies in its phase II clinical stage in Taiwan, US and Japan. The Taiwan phase II clinical trial for spinocerebellar ataxia treatment is completed and is preparing for publish to internal journal . With unique patented cell properties, Stemchymal® cell product 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).
2007 | Steminent Biotherapeutics Inc.(SBI) was founded. |
2014 | SBI completed the Taiwan phase I clinical trial for SCA treatment. |
2015 | SBI received Orphan Drug Designation for SCA treatment from USFDA; SBI received Taiwan phase I clinical trial approval for osteoarthritis knee treatment. |
2018 | SBI received USFDA phase II clinical trial approval for SCA treatment; SBI with the Japanese licensee (REPROCELL) received Japan PMDA phase II clinical trial approval for SCA treatment; SBI completed the Taiwan phase I clinical trial for osteoarthritis knee treatment; SBI received Taiwan phase I clinical trial approval for ALF treatment. |
2020 | SBI completed the Taiwan phase II clinical trial for SCA treatment; conduct phase II clinical trial for SCA treatment in Japan;SBI completed the out-licensing with its Korean partner. |
2022 | Completed the Japan phase II clinical trial for SCA treatment with SBI’s partner REPROCELL |
2023 | Became a public company; Received the 20th National Innovation Award |
2024 | Become a listed company in the Emerging Stock market; Received Taiwan Bio Award as an Emerging Company of the Year |
2024 | Completed the construction of cell production factory that complies with PIC/S GMP specifications and about to submit the application for regulatory inspection. |