Table 3 List of approved regenerative medicine in Japan
Approval date | By approval | MAHs | Brand name | Common name | Origin of ingredients | Provision of non-standard products |
|---|---|---|---|---|---|---|
2007/10/29 | Approval | Japan Tissue Engineering Co., Ltd | JACE | Human (autologous) epidermis-derived cell sheet | Autologous | No |
2012/7/27 | Approval | Japan Tissue Engineering Co., Ltd | JACC | Human (autologous) epidermis-derived cell sheet | Autologous | No |
2015/9/18 | Approval | JCR Pharma Co., Ltd | Temcel HS Injection | Human (allogeneic) bone marrow-derived mesenchymal stem cells | Allogeneic | NA |
2015/9/18 | Conditional time-limited approval | Terumo Corporation | Heart Sheet* | Human (autologous) skeletal muscle-derived cell sheet | Autologous | Yes (clinical trial) |
2018/12/28 | Conditional time-limited approval | Nipro Corporation | Stemirac for Injection | Human (autologous) bone marrow-derived mesenchymal stem cells | Autologous | Yes (clinical trial) |
2019/3/26 | Approval | Novartis Pharma K.K | Kymriah Suspension for Intravenous Infusion | Tisagenlecleucel | Autologous | Yes (clinical trial) |
2019/3/26 | Conditional time-limited approval | AnGes Inc | Collategene Intramuscular Injection 4Â mg* | Beperminogene Perplasmid | Others (hHGF expression plasmid DNA) | NA |
2020/03/19 | Approval | Novartis Pharma K.K | Zolgensma Intravenous Infusion | Onasemnogen abeparvovec | Others (genetically modified adeno-associated virus) | NA |
2020/03/19 | Approval | Japan Tissue Engineering Co., Ltd | Nepic | Human (autologous) limbal derived corneal epithelial cell sheet | Autologous | No |
2021/01/22 | Approval | Gilead Sciences Inc | YESCARTA Intravenous Drip Infusion | Axicabtagene ciloleucel | Autologous | Yes (clinical trial) |
2021/03/22 | Approval | Celgene Corporation | Breyanzi Suspension for Intravenous Infusion | Lisocabtagene maraleucel | Autologous | Yes (clinical trial) |
June 11, 2021 | Approval | Japan Tissue Engineering Co., Ltd | Ocural | Human (autologous) oral mucosa-derived epithelial cell sheet | Autologous | No |
June 11, 2021 | Conditional time-limited approval | Daiichi Sankyo Co., Ltd | Delytact Injection | Teserpaturev | Others (genetically modified herpes simplex virus type 1) | NA |
2021/9/27 | Approval | Takeda Pharmaceutical Company Limited | Aloficel Injection | Darvadstrocel | Allogeneic | NA |
2022/01/20 | Approval | Hirosaki Lifescience Innovation, Inc | Sakracy | Human (autologous) oral mucosa-derived epithelial cell sheet using human amniotic membrane substrate | Autologous | NA |
2022/01/20 | Approval | Bristol-Myers Squibb K.K | Abecma Intravenous Infusion | Idecabtagene vicleucel | Autologous | Yes (clinical trial) |
2022/9/26 | Approval | Janssen Pharmaceutical K.K | Carvykti Suspension for Intravenous Infusion | Ciltacabtagene autoleucel | Autologous | Under consideration |
2023/03/17 | Approval | Japan Tissue Engineering Co., Ltd | JACEMIN | Melanocyte-containing human (autologous) epidermis-derived Cell Sheet | Autologous | No |
2023/03/17 | Approval | Aurion Biotech Japan LLC | Vyznova | Neltependocel | Allogeneic | NA |
2023/6/26 | Approval | Novartis Pharma K.K | Luxturna Injection | Voretigene neparvovec | others (genetically modified adeno-associated virus) | NA |
2024/7/31 | Conditional time-limited approval | SanBio Company Limited | AKUUGO | Vandefitemcel | Allogenic | NA |