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Bufei Jianpi granule
Bufei Jianpi granule is a Small molecule drug developed by Henan University of Traditional Chinese Medicine. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD), Chronic bronchitis, Pulmonary fibrosis.
Bufei Jianpi granule is a traditional Chinese medicine formulation that aims to strengthen lung and spleen function to improve respiratory health and immune function.
Bufei Jianpi granule is a traditional Chinese medicine formulation that aims to strengthen lung and spleen function to improve respiratory health and immune function. Used for Chronic obstructive pulmonary disease (COPD), Chronic bronchitis, Pulmonary fibrosis.
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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 Jianpi granule |
|---|---|
| Sponsor | Henan University of Traditional Chinese Medicine |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonary Medicine |
| Phase | Phase 3 |
Mechanism of action
This herbal granule combines multiple traditional Chinese medicinal ingredients designed to tonify the spleen (Jianpi) and fortify the lungs (Bufei) according to TCM theory. The formulation is intended to enhance qi circulation, reduce inflammation, and support respiratory and digestive system function, potentially improving symptoms in chronic respiratory conditions.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
- Chronic bronchitis
- Pulmonary fibrosis
Common side effects
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:
- Bufei Jianpi granule CI brief — competitive landscape report
- Bufei Jianpi granule updates RSS · CI watch RSS
- Henan University of Traditional Chinese Medicine portfolio CI
Frequently asked questions about Bufei Jianpi granule
What is Bufei Jianpi granule?
How does Bufei Jianpi granule work?
What is Bufei Jianpi granule used for?
Who makes Bufei Jianpi granule?
What development phase is Bufei Jianpi granule in?
Related
- Manufacturer: Henan University of Traditional Chinese Medicine — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonary Medicine
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Indication: Drugs for Chronic bronchitis
- Indication: Drugs for Pulmonary fibrosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing