Last reviewed 2026-05-23 · How we verify

Tolipalimab

Sun Yat-sen University · Phase 2 active Small molecule ✓ Verified May 2026

Tolipalimab is a Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 2 development. Also known as: JS001.

Tolipalimab is being studied in clinical trials for the treatment of Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, and Head and Neck Neoplasm. It is being used in combination with intensity-modulated radiotherapy and reirradiation in these trials.

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 name	Tolipalimab
Also known as	JS001
Sponsor	Sun Yat-sen University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma. (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:

Tolipalimab CI brief — competitive landscape report
Tolipalimab updates RSS · CI watch RSS
Sun Yat-sen University portfolio CI

Frequently asked questions about Tolipalimab

What is Tolipalimab?

Tolipalimab is a Small molecule drug developed by Sun Yat-sen University.

Who makes Tolipalimab?

Tolipalimab is developed by Sun Yat-sen University (see full Sun Yat-sen University pipeline at /company/sun-yat-sen-university).

Is Tolipalimab also known as anything else?

Tolipalimab is also known as JS001.

What development phase is Tolipalimab in?

Tolipalimab is in Phase 2.

Manufacturer: Sun Yat-sen University — full pipeline
Therapeutic area: All drugs in Other
Also known as: JS001

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