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Bufei Yishen granule
Bufei Yishen granule is a Herbal medicine / Traditional Chinese Medicine Small molecule drug developed by Henan University of Traditional Chinese Medicine. It is currently in Phase 3 development for Chronic kidney disease with respiratory involvement, Chronic obstructive pulmonary disease (COPD) with kidney deficiency.
Bufei Yishen granule is a traditional Chinese medicine formulation that aims to tonify lung and kidney function to improve respiratory and renal health.
Bufei Yishen granule is a traditional Chinese medicine formulation that aims to tonify lung and kidney function to improve respiratory and renal health. Used for Chronic kidney disease with respiratory involvement, Chronic obstructive pulmonary disease (COPD) with kidney deficiency.
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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).
| 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 | Bufei Yishen granule |
|---|---|
| Sponsor | Henan University of Traditional Chinese Medicine |
| Drug class | Herbal medicine / Traditional Chinese Medicine |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Renal |
| Phase | Phase 3 |
Mechanism of action
This herbal granule combines multiple traditional Chinese medicinal ingredients believed to strengthen lung (bufei) and kidney (yishen) systems according to TCM theory. The formulation is designed to address deficiencies in these organ systems that may contribute to chronic respiratory and renal conditions. It is typically used to support respiratory function and kidney health in patients with chronic diseases.
Approved indications
- Chronic kidney disease with respiratory involvement
- Chronic obstructive pulmonary disease (COPD) with kidney deficiency
Common side effects
Key clinical trials
- Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage (NA)
- Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD (PHASE3)
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:
- Bufei Yishen granule CI brief — competitive landscape report
- Bufei Yishen granule updates RSS · CI watch RSS
- Henan University of Traditional Chinese Medicine portfolio CI
Frequently asked questions about Bufei Yishen granule
What is Bufei Yishen granule?
How does Bufei Yishen granule work?
What is Bufei Yishen granule used for?
Who makes Bufei Yishen granule?
What drug class is Bufei Yishen granule in?
What development phase is Bufei Yishen granule in?
Related
- Drug class: All Herbal medicine / Traditional Chinese Medicine drugs
- Manufacturer: Henan University of Traditional Chinese Medicine — full pipeline
- Therapeutic area: All drugs in Respiratory / Renal
- Indication: Drugs for Chronic kidney disease with respiratory involvement
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) with kidney deficiency
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing