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HRS-5965 tablets
HRS-5965 tablets is a Small molecule drug developed by Chengdu Suncadia Medicine Co., Ltd.. It is currently in Phase 2 development.
HRS-5965 tablets are being studied in clinical trials for the treatment of Paroxysmal Nocturnal Hemoglobinuria, IgA Nephropathy, Primary IgA Nephropathy, and Glomerulonephritis. The exact mechanism of action of HRS-5965 tablets is not specified in the available information, but it is being investigated in a long-term safety and tolerability study for Paroxysmal Nocturnal Hemoglobinuria.
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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 | HRS-5965 tablets |
|---|---|
| Sponsor | Chengdu Suncadia Medicine Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects (PHASE1)
- Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PHASE2)
- A Trial of HRS-5965 Tablets in Primary IgA Nephropathy (PHASE2)
- Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency (PHASE1)
- Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PHASE2)
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:
- HRS-5965 tablets CI brief — competitive landscape report
- HRS-5965 tablets updates RSS · CI watch RSS
- Chengdu Suncadia Medicine Co., Ltd. portfolio CI
Frequently asked questions about HRS-5965 tablets
What is HRS-5965 tablets?
Who makes HRS-5965 tablets?
What development phase is HRS-5965 tablets in?
Related
- Manufacturer: Chengdu Suncadia Medicine Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing