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Drug - SHR1459
Drug - SHR1459 is a Small molecule drug developed by Reistone Biopharma Company Limited. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Drug - SHR1459 |
|---|---|
| Sponsor | Reistone Biopharma Company Limited |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy (PHASE2)
- An Open Label Study of the Effects of SHR1459 in NMOSDs Patients (PHASE2)
- A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers (PHASE1)
- Drug-Drug Interaction of SHR1459 With a Strong CYP3A Index Inducer (Rifampicin) (PHASE1)
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:
- Drug - SHR1459 CI brief — competitive landscape report
- Drug - SHR1459 updates RSS · CI watch RSS
- Reistone Biopharma Company Limited portfolio CI
Frequently asked questions about Drug - SHR1459
What is Drug - SHR1459?
Who makes Drug - SHR1459?
What development phase is Drug - SHR1459 in?
Related
- Manufacturer: Reistone Biopharma Company Limited — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing