Last reviewed · How we verify

Aipalolitovorelizumab

Harbin Medical University · Phase 2 active Small molecule ✓ Verified May 2026

Aipalolitovorelizumab is a Small molecule drug developed by Harbin Medical University. It is currently in Phase 2 development.

Aipalolitovorelizumab is being studied in a Phase II clinical trial for the treatment of immunodominant pMMR/MSS metastatic colorectal cancer that has failed second-line or above treatment. The trial combines Aipalolitovorelizumab with Fruquintinib and is conducted by Harbin Medical University.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameAipalolitovorelizumab
SponsorHarbin Medical University
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Aipalolitovorelizumab

What is Aipalolitovorelizumab?

Aipalolitovorelizumab is a Small molecule drug developed by Harbin Medical University.

Who makes Aipalolitovorelizumab?

Aipalolitovorelizumab is developed by Harbin Medical University (see full Harbin Medical University pipeline at /company/harbin-medical-university).

What development phase is Aipalolitovorelizumab in?

Aipalolitovorelizumab is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing