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Fruquintinib in Combination with Sintilimab

Hutchmed · Phase 1 active Small molecule

Fruquintinib in Combination with Sintilimab is a Small molecule drug developed by Hutchmed. It is currently in Phase 1 development. Also known as: Fruquintinib.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameFruquintinib in Combination with Sintilimab
Also known asFruquintinib
SponsorHutchmed
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Fruquintinib in Combination with Sintilimab

What is Fruquintinib in Combination with Sintilimab?

Fruquintinib in Combination with Sintilimab is a Small molecule drug developed by Hutchmed.

Who makes Fruquintinib in Combination with Sintilimab?

Fruquintinib in Combination with Sintilimab is developed by Hutchmed (see full Hutchmed pipeline at /company/hutchmed).

Is Fruquintinib in Combination with Sintilimab also known as anything else?

Fruquintinib in Combination with Sintilimab is also known as Fruquintinib.

What development phase is Fruquintinib in Combination with Sintilimab in?

Fruquintinib in Combination with Sintilimab is in Phase 1.

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