Last reviewed · How we verify
Dendrobium Huoshanense Suppository
Dendrobium Huoshanense Suppository is a Herbal immunomodulator Small molecule drug developed by Zhejiang Cancer Hospital. It is currently in Phase 3 development for Cancer (specific indication not publicly detailed; Phase 3 status suggests advanced solid tumors or hematologic malignancy).
Dendrobium Huoshanense extract suppository delivers bioactive polysaccharides and alkaloids that enhance immune function and promote apoptosis in cancer cells.
Dendrobium Huoshanense Suppository is being studied as a treatment for locally advanced rectal cancer in a multicenter randomized controlled clinical trial. The study, titled "A Multicenter Randomized Controlled Stage III Clinical Study of Dendrobium Huoshanense Suppository in Locally Advanced Rectal Cancer Patients Treated by Neoadjuvant Chemoradiotherapy," is being conducted at the Zhejiang Cancer Hospital.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Dendrobium Huoshanense Suppository |
|---|---|
| Sponsor | Zhejiang Cancer Hospital |
| Drug class | Herbal immunomodulator |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Dendrobium Huoshanense is a traditional Chinese medicinal orchid whose active constituents, including polysaccharides and alkaloid compounds, are believed to stimulate natural killer cells and T-cell mediated immunity while inducing programmed cell death in malignant cells. The suppository formulation allows direct mucosal absorption and systemic distribution of these immunomodulatory and cytotoxic agents.
Approved indications
- Cancer (specific indication not publicly detailed; Phase 3 status suggests advanced solid tumors or hematologic malignancy)
Common side effects
- Gastrointestinal irritation
- Local rectal discomfort
- Allergic reaction
Key clinical trials
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:
- Dendrobium Huoshanense Suppository CI brief — competitive landscape report
- Dendrobium Huoshanense Suppository updates RSS · CI watch RSS
- Zhejiang Cancer Hospital portfolio CI
Frequently asked questions about Dendrobium Huoshanense Suppository
What is Dendrobium Huoshanense Suppository?
How does Dendrobium Huoshanense Suppository work?
What is Dendrobium Huoshanense Suppository used for?
Who makes Dendrobium Huoshanense Suppository?
What drug class is Dendrobium Huoshanense Suppository in?
What development phase is Dendrobium Huoshanense Suppository in?
What are the side effects of Dendrobium Huoshanense Suppository?
Related
- Drug class: All Herbal immunomodulator drugs
- Manufacturer: Zhejiang Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cancer (specific indication not publicly detailed; Phase 3 status suggests advanced solid tumors or hematologic malignancy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing