Last reviewed · How we verify
Bufei Huatan granule
Bufei Huatan granule is a Small molecule drug developed by Henan University of Traditional Chinese Medicine. It is currently in Phase 3 development for Chronic respiratory conditions with phlegm accumulation, Lung function support in traditional Chinese medicine practice.
Bufei Huatan granule is a traditional Chinese medicine formulation that promotes lung function and clears phlegm to treat respiratory conditions.
Bufei Huatan granule is a traditional Chinese medicine formulation that promotes lung function and clears phlegm to treat respiratory conditions. Used for Chronic respiratory conditions with phlegm accumulation, Lung function support in traditional Chinese medicine practice.
-
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 Huatan granule |
|---|---|
| Sponsor | Henan University of Traditional Chinese Medicine |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
This herbal granule combines multiple traditional Chinese medicinal ingredients designed to tonify the lungs, eliminate dampness, and resolve phlegm accumulation. It is used in Chinese medicine practice to address chronic respiratory symptoms and improve airway clearance through traditional mechanisms of action that are not fully characterized by Western pharmacological standards.
Approved indications
- Chronic respiratory conditions with phlegm accumulation
- Lung function support in traditional Chinese medicine practice
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 Huatan granule CI brief — competitive landscape report
- Bufei Huatan granule updates RSS · CI watch RSS
- Henan University of Traditional Chinese Medicine portfolio CI
Frequently asked questions about Bufei Huatan granule
What is Bufei Huatan granule?
How does Bufei Huatan granule work?
What is Bufei Huatan granule used for?
Who makes Bufei Huatan granule?
What development phase is Bufei Huatan granule in?
Related
- Manufacturer: Henan University of Traditional Chinese Medicine — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Chronic respiratory conditions with phlegm accumulation
- Indication: Drugs for Lung function support in traditional Chinese medicine practice
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing