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NH280105- MAD
NH280105- MAD is a Small molecule drug developed by Jiangsu Nhwa Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.
NH280105 is a small molecule being studied in a Phase 1 clinical trial for Alzheimer Disease. The trial is evaluating the safety and tolerability of NH280105 in healthy adult participants through single and multiple ascending dose administration.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | NH280105- MAD |
|---|---|
| Sponsor | Jiangsu Nhwa Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
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:
- NH280105- MAD CI brief — competitive landscape report
- NH280105- MAD updates RSS · CI watch RSS
- Jiangsu Nhwa Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about NH280105- MAD
What is NH280105- MAD?
Who makes NH280105- MAD?
What development phase is NH280105- MAD in?
Related
- Manufacturer: Jiangsu Nhwa Pharmaceutical Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing