Drugs / Stemchymal®
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | Stemchymal® | spinocerebellar ataxia types 3 and 6 | 2026-06-24 | “旗下小腦萎縮症的幹細胞新藥，已由日本授權夥伴送件申請日本的「暫時性藥證許可」” steminent.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03629015 | Oct 2018 → May 2020 | acute liver failure, chronic liver failure | Steminent Biotherapeutics Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 22 trials | ||||||
| Phase 2 | NCT06397274 | Jun 2025 → Jun 2028 expected | cerebellar ataxia | Steminent US, Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02540655 | Sep 2015 → Feb 2021 | cerebellar ataxia | Steminent Biotherapeutics Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-07-06 | Steminent Biotherapeutics Inc. | Regulatory 仲恩生醫新藥Stemchymal獲T-RMAT資格 steminent.com ↗
公司「Stemchymal」用於脊髓小腦退化性動作協調障礙 (Spinocerebellar Ataxia,SCA)，業經評選通過，核定列入T-RMAT輔導專案。 |
| 2026-06-24 | Steminent Biotherapeutics Inc. | Regulatory 有望成為台灣國際取證第二家！ 仲恩幹細胞新藥日本送件 可望2027年取證 steminent.com ↗
仲恩生醫（7729）今（24）日宣布，旗下小腦萎縮症的幹細胞新藥，已由日本授權夥伴送件申請日本的「暫時性藥證許可」，最快可望於2027年上半年取證。 |
| 2025-04-24 | Steminent Biotherapeutics Inc. | Results 仲恩台日小腦萎縮臨床二期數據出爐 病程控制穩定 steminent.com ↗
結果顯示治療組的疾病控制穩定，展現顯著的臨床改善。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-06 | Steminent Biotherapeutics Inc. | 仲恩生醫新藥Stemchymal獲T-RMAT資格 steminent.com ↗ |
| 2026-06-24 | Steminent Biotherapeutics Inc. | 有望成為台灣國際取證第二家！ 仲恩幹細胞新藥日本送件 可望2027年取證 steminent.com ↗ |
| 2025-04-24 | Steminent Biotherapeutics Inc. | 仲恩台日小腦萎縮臨床二期數據出爐 病程控制穩定 steminent.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Stemchymal | “Patients will receive Stemchymal® through intravenous infusion” NCT06397274 ↗ |
| Modality | Cell therapy | “Allogeneic Adipose-Derived Mesenchymal Stem Cells” NCT03629015 ↗ |
| Route | Intravenous | “Patients will receive Stemchymal® through intravenous infusion” NCT02540655 ↗ |