亞洲 iPSC 與幹細胞療法
幹細胞療法:用活細胞修補或取代受損組織。
8追蹤資產
8已核准
這個賽道在做什麼
幹細胞療法用活的細胞修補或取代受損組織。誘導性多能幹細胞(iPSC)是把成人細胞重新編程回類似胚胎的狀態,這項日本發現拿下 2012 年諾貝爾獎,可以再分化成心肌、神經或眼睛細胞。日本的條件式核准制度讓再生醫療產品在較小規模試驗後就能用在病人身上,2026 年首批 iPSC 衍生產品在日本獲准。韓國更早在 2011 到 2014 年間就核准了幾個成體幹細胞產品。
階段分布
已核准8 8
國家分布
日本4 4
韓國4 4
資產表
| 排名 | 資產 | 國際非專利名稱 | 原研公司 | 國家 | 標的 | 機轉 | 最高階段 | 適應症 | 試驗登錄號 | 海外權利人 | 交易日期 | 首付款 | 總額上限 | 最新事件 | 最新事件日期 | 來源 | 來源日期 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RiHEART | Not disclosed | Cuorips Inc. (Osaka University / Daiichi Sankyo technology) | Japan | Ischaemic myocardium | Allogeneic iPSC-derived cardiomyocyte patch; intended paracrine support of myocardial function | Approved — Japan (2026-03; conditional and time-limited) | Severe heart failure due to ischaemic cardiomyopathy refractory to standard pharmacological/invasive therapy | NCT04696328 | None reported | — | — | — | Japan conditional and time-limited marketing authorisation granted | 2026-03-06 | 1 2 3 4 | 2026-11-03 |
| 2 | AMCHEPRY | raguneprocel | Sumitomo Pharma / RACTHERA (Kyoto University technology) | Japan | Dopaminergic neuronal loss | Allogeneic iPSC-derived dopaminergic neural progenitor cell therapy | Approved — Japan (2026-03; conditional and time-limited) | Parkinson disease motor symptoms inadequately controlled by existing therapies including levodopa | Not disclosed | None reported | — | — | — | Japan conditional and time-limited marketing authorisation granted | 2026-03-06 | 1 2 3 | 2026-11-03 |
| 3 | AKUUGO (SB623) | vandefitemcel | SanBio Company Limited | Japan | Chronic traumatic brain injury motor deficits | Modified allogeneic bone-marrow MSC therapy; proposed cytokine-mediated neural repair | Approved — Japan (2024-07; conditional and time-limited) | Improvement of chronic motor paralysis associated with traumatic brain injury | NCT02416492 | None reported | — | — | — | SanBio announced first post-marketing administration of AKUUGO | 2026-10-07 | 1 2 3 4 5 | 2026-11-03 |
| 4 | STEMIRAC | Not disclosed | Nipro Corporation / Sapporo Medical University | Japan | Traumatic spinal cord injury | Autologous bone-marrow mesenchymal stem cell therapy | Approved — Japan (2018-12; conditional and time-limited; full-approval panel endorsement 2026-10) | Spinal cord injury | Not disclosed | None reported | — | — | — | Panel endorsed full approval on 2026-10-15; source says formal ministerial approval still expected | 2026-10-15 | 1 2 3 | 2026-11-03 |
| 5 | NEURONATA-R | lenzumestrocel | CorestemChemon Inc. | South Korea | ALS-associated motor-neuron injury / neuroinflammation | Autologous bone-marrow MSC therapy with immunomodulatory/neurotrophic rationale | Approved — South Korea (2014-07; conditional; continued use approved 2026-05) | Delaying ALS progression, with riluzole | NCT04745299 | None reported | — | — | — | Issuer reports May 2026 licence modification retaining conditional access; manufacturing restart planned | 2026-07-20 | 1 2 3 | 2026-11-03 |
| 6 | Cupistem | Not disclosed | Anterogen Co., Ltd. | South Korea | Crohn disease-associated fistula | Adipose-derived stem cell therapy | Approved — South Korea (2012-01) | Crohn disease fistula | Not disclosed | None reported | — | — | — | Korean marketing authorisation obtained (historical approval; no newer asset-specific event established) | 2012-01 | 1 2 | 2026-11-03 |
| 7 | CARTISTEM | Not disclosed | MEDIPOST Co., Ltd. | South Korea | Osteoarthritic knee cartilage defects | Allogeneic umbilical cord blood-derived MSC therapy | Approved — South Korea (2012-01) | ICRS grade IV knee cartilage defects associated with degeneration or repetitive trauma | NCT07339111 | Teikoku Seiyaku (exclusive Japan sales/distribution/promotion); MEDIPOST retains manufacturing | 2025-12-19 | USD 8m | Not disclosed (USD 10m regulatory milestone; sales milestones undisclosed) | First US participant treated in Phase 3; Korean approval and Japan Phase 3 completion are separate milestones | 2026-07-07 | 1 2 3 4 5 | 2026-11-03 |
| 8 | Hearticellgram-AMI | Not disclosed | Pharmicell Co., Ltd. | South Korea | Post-infarction left-ventricular dysfunction | Autologous bone-marrow MSC therapy for cardiac functional recovery | Approved — South Korea (2011-07) | Improving left-ventricular ejection fraction after acute myocardial infarction | NCT01652209 | None reported | — | — | — | Korean approval recorded by MFDS (historical approval; no newer asset-specific event established) | 2011-07 | 1 2 3 | 2026-11-03 |