Drugs / RY_SW01
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | 弥漫型系统性硬化症 | 2026-05-21 | “RY_SW01 细胞注射液 （受理号：CXSS2600086）新药上市申请正式获受理” hopstem.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06058091 | Sep 2023 → Dec 2025 overdue | systemic sclerosis | Jiangsu Renocell Biotech Company | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06058078 | Aug 2023 → Dec 2025 overdue | lupus nephritis | Jiangsu Renocell Biotech Company | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Hopstem Biotechnology Inc. | Regulatory 2026【五月精选】领域最新进展 hopstem.com ↗
5月21日，国家药品监督管理局药品审评中心（CDE）官网显示，江苏睿源生物申报的 RY_SW01 细胞注射液 （受理号：CXSS2600086）新药上市申请正式获受理，拟定适应症为 弥漫型系统性硬化症（ 硬皮病 ） 。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Hopstem Biotechnology Inc. | 2026【五月精选】领域最新进展 hopstem.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RY_SW01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06058091 ↗ |
| Modality | Cell therapy | “Injected RY\_SW01 allogonic umbilical cord-derived mesenchymal stem cells(UCMSCs)” NCT06058078 ↗ |