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HRS-1301 Tablet
HRS-1301 Tablet is a Small molecule drug developed by Shandong Suncadia Medicine Co., Ltd.. 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 | HRS-1301 Tablet |
|---|---|
| Sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects (PHASE1)
- A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function (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:
- HRS-1301 Tablet CI brief — competitive landscape report
- HRS-1301 Tablet updates RSS · CI watch RSS
- Shandong Suncadia Medicine Co., Ltd. portfolio CI
Frequently asked questions about HRS-1301 Tablet
What is HRS-1301 Tablet?
Who makes HRS-1301 Tablet?
What development phase is HRS-1301 Tablet in?
Related
- Manufacturer: Shandong Suncadia Medicine Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing