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Anlotinib(blank)
Anlotinib(blank) is a Multi-targeted tyrosine kinase inhibitor Small molecule drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. It is currently in Phase 3 development for Advanced non-small cell lung cancer, Medullary thyroid cancer, Soft tissue sarcoma.
Anlotinib is a multi-targeted tyrosine kinase inhibitor that blocks angiogenesis and tumor growth by inhibiting VEGFR, FGFR, PDGFR, and other kinases.
Anlotinib is a multi-targeted tyrosine kinase inhibitor that blocks angiogenesis and tumor growth by inhibiting VEGFR, FGFR, PDGFR, and other kinases. Used for Advanced non-small cell lung cancer, Medullary thyroid cancer, Soft tissue sarcoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Anlotinib(blank) |
|---|---|
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Drug class | Multi-targeted tyrosine kinase inhibitor |
| Target | VEGFR2, FGFR1, PDGFR-β, c-Kit, Ret |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Anlotinib inhibits multiple receptor tyrosine kinases involved in tumor angiogenesis and growth signaling, including VEGFR2, FGFR1, PDGFR-β, and c-Kit. By blocking these pathways, it reduces new blood vessel formation to tumors and directly inhibits tumor cell proliferation and survival.
Approved indications
- Advanced non-small cell lung cancer
- Medullary thyroid cancer
- Soft tissue sarcoma
Common side effects
- Hypertension
- Proteinuria
- Hand-foot skin reaction
- Fatigue
- Diarrhea
- Anorexia
- Nausea
Key clinical trials
- Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029） (PHASE2)
- A Study of TQB2450 in Subjects With Stage III Non-Small Cell Lung Cancer(NSCLC) (PHASE3)
- A Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer (ETER701) (PHASE3)
- Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer (PHASE3)
- Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer (PHASE3)
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:
- Anlotinib(blank) CI brief — competitive landscape report
- Anlotinib(blank) updates RSS · CI watch RSS
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. portfolio CI
Frequently asked questions about Anlotinib(blank)
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Related
- Drug class: All Multi-targeted tyrosine kinase inhibitor drugs
- Target: All drugs targeting VEGFR2, FGFR1, PDGFR-β, c-Kit, Ret
- Manufacturer: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced non-small cell lung cancer
- Indication: Drugs for Medullary thyroid cancer
- Indication: Drugs for Soft tissue sarcoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing