Last reviewed 2026-05-19 · How we verify

Pemetrixed

The First Affiliated Hospital of Xiamen University · Phase 2 active Small molecule ✓ Verified May 2026

Pemetrixed is a Small molecule drug developed by The First Affiliated Hospital of Xiamen University. It is currently in Phase 2 development.

Pemetrixed is a chemotherapy drug used in combination with other treatments, including Camrelizumab and Apatinib, for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have failed tyrosine kinase inhibitor therapy. It is typically administered with carboplatin as part of the treatment regimen.

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	Pemetrixed
Sponsor	The First Affiliated Hospital of Xiamen 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

Camrelizumab Combined With Apatinib Mesylate and Standard Chemotherapy (Pemetrixed + Carboplatin) in Patients With Tyrosine Kinase Inhibitor Failure in ALK-positive Advanced NSCLC (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:

Pemetrixed CI brief — competitive landscape report
Pemetrixed updates RSS · CI watch RSS
The First Affiliated Hospital of Xiamen University portfolio CI

Frequently asked questions about Pemetrixed

What is Pemetrixed?

Pemetrixed is a Small molecule drug developed by The First Affiliated Hospital of Xiamen University.

Who makes Pemetrixed?

Pemetrixed is developed by The First Affiliated Hospital of Xiamen University (see full The First Affiliated Hospital of Xiamen University pipeline at /company/the-first-affiliated-hospital-of-xiamen-university).

What development phase is Pemetrixed in?

Pemetrixed is in Phase 2.

Manufacturer: The First Affiliated Hospital of Xiamen University — full pipeline
Therapeutic area: All drugs in Other

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