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Famitinib capsule
Famitinib capsule is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 1 development. Also known as: SHR1020.
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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 | Famitinib capsule |
|---|---|
| Also known as | SHR1020 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of SHR-1802 in Patients With Advanced Solid Tumor (PHASE2)
- Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib (PHASE3)
- A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC (PHASE3)
- Pharmacokinetics Study of Famitinib Malate Capsules in Healthy Subjects (PHASE1)
- Bioequivalence Study of Famitinib Malate in Healthy Volunteers Under Fasting Condition (PHASE1)
- A Trial of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients (PHASE2)
- A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer (PHASE3)
- Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors (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:
- Famitinib capsule CI brief — competitive landscape report
- Famitinib capsule updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about Famitinib capsule
What is Famitinib capsule?
Who makes Famitinib capsule?
Is Famitinib capsule also known as anything else?
What development phase is Famitinib capsule in?
Related
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Also known as: SHR1020
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing