Asia iPSC and stem-cell therapies
Stem-cell therapies: repairing or replacing damaged tissue with living cells.
8Tracked assets
8Approved
How this track works
Stem-cell therapies use living cells to repair or replace damaged tissue. Induced pluripotent stem cells (iPSCs) are adult cells reprogrammed into an embryo-like state, a Japanese discovery that won the 2012 Nobel Prize, and they can be turned into heart, nerve or eye cells. Japan's conditional approval pathway lets regenerative medicines reach patients after smaller trials, and in 2026 the first iPSC-derived products were approved there. South Korea approved several adult stem-cell products earlier, between 2011 and 2014.
Development stage
Approved8 8
Origin country / region
Japan4 4
South Korea4 4
Assets
| Rank | Asset | INN | Originator | Country | Targets | Mechanism | Highest stage | Indication | Trial IDs | Overseas rights holder | Deal date | Upfront | Total ceiling | Latest event | Latest event date | Sources | Source date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |