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Sunitinib malate capsules reference product
Sunitinib malate capsules reference product is a Multi-targeted receptor tyrosine kinase inhibitor Small molecule drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. It is currently in Phase 1 development.
Multi-targeted receptor tyrosine kinase inhibitor that blocks VEGFR, PDGFR, KIT, FLT3, and RET signaling pathways involved in tumor growth and angiogenesis.
Sunitinib malate capsules are a small molecule used to treat conditions such as gastrointestinal stromal tumors, renal cell carcinoma, and pancreatic neuroendocrine tumors. The bioequivalence of sunitinib malate capsules has been studied in a clinical trial, comparing them to the reference product Sutent.
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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 | Sunitinib malate capsules reference product |
|---|---|
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Drug class | Multi-targeted receptor tyrosine kinase inhibitor |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Sunitinib inhibits multiple receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR1-3), platelet-derived growth factor receptors (PDGFR-α and PDGFR-β), KIT, FLT3, and RET. By blocking these pathways, it inhibits tumor angiogenesis and directly suppresses tumor cell proliferation.
Approved indications
Common side effects
Key clinical trials
- A Bioequivalence Study of Sunitinib Malate Capsules. (PHASE1)
- The Bioequivalence Study of Two Sunitinib Products in Capsules 50 mg in Healthy Volunteers Under Fasting Conditions (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:
- Sunitinib malate capsules reference product CI brief — competitive landscape report
- Sunitinib malate capsules reference product updates RSS · CI watch RSS
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. portfolio CI
Frequently asked questions about Sunitinib malate capsules reference product
What is Sunitinib malate capsules reference product?
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Related
- Drug class: All Multi-targeted receptor tyrosine kinase inhibitor drugs
- Manufacturer: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing