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HRS-6209
HRS-6209 is a Small molecule drug developed by Shandong Suncadia Medicine Co., Ltd.. It is currently in Phase 1 development.
HRS-6209 is being studied in clinical trials for various breast cancer conditions, including triple-negative breast cancer and HER2-positive breast cancer. The purpose of one of these trials is to estimate the effect of formulation and food on the relative bioavailability of HRS-6209 in healthy participants.
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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 | HRS-6209 |
|---|---|
| Sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase I Clinical Study of the Safety， Tolerability，Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors (PHASE1)
- A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer (PHASE1, PHASE2)
- A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients (PHASE1, PHASE2)
- To Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects With HR-Positive/HER2-Negative Solid Tumor (PHASE1)
- A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer (PHASE1, PHASE2)
- A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients (PHASE1, 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-6209 CI brief — competitive landscape report
- HRS-6209 updates RSS · CI watch RSS
- Shandong Suncadia Medicine Co., Ltd. portfolio CI
Frequently asked questions about HRS-6209
What is HRS-6209?
Who makes HRS-6209?
What development phase is HRS-6209 in?
Related
- Manufacturer: Shandong Suncadia Medicine Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing