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HRS-9813 capsules
HRS-9813 capsules is a Small molecule drug developed by Guangdong Hengrui Pharmaceutical Co., Ltd. It is currently in Phase 2 development.
HRS-9813 capsules are being studied in a Phase II clinical trial for the treatment of pulmonary fibrosis, specifically idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The trial is evaluating the efficacy and safety of HRS-9813 capsules in comparison to a placebo.
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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-9813 capsules |
|---|---|
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis (PHASE2)
- Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects (PHASE1)
- A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects (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-9813 capsules CI brief — competitive landscape report
- HRS-9813 capsules updates RSS · CI watch RSS
- Guangdong Hengrui Pharmaceutical Co., Ltd portfolio CI
Frequently asked questions about HRS-9813 capsules
What is HRS-9813 capsules?
Who makes HRS-9813 capsules?
What development phase is HRS-9813 capsules in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing