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the second donor's stem cell
the second donor's stem cell is a Biologic drug developed by huishengai. It is currently in Phase 2 development.
A donor stem cell transplant was conducted as part of a study for patients with various blood cancers, including Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Plasma Cell Neoplasm, and Myelodysplastic Syndromes. The transplant involved the use of anti-thymocyte globulin, filgrastim, and busulfan as part of the treatment regimen.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | the second donor's stem cell |
|---|---|
| Sponsor | huishengai |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer (PHASE2)
- Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- the second donor's stem cell CI brief — competitive landscape report
- the second donor's stem cell updates RSS · CI watch RSS
- huishengai portfolio CI
Frequently asked questions about the second donor's stem cell
What is the second donor's stem cell?
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What development phase is the second donor's stem cell in?
Related
- Manufacturer: huishengai — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing