Last reviewed 2026-05-19 · How we verify

Pytotinib

Sun Yat-sen University · Phase 1 active Small molecule ✓ Verified May 2026

Pytotinib is a Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 1 development.

Pytotinib is a medication being studied in combination with inetetamab for the treatment of advanced Non-small Cell Lung Cancer, specifically in cases with HER2 mutations or amplifications. The exact mechanism of action of Pytotinib is not specified in the provided information, but it is being investigated in a Phase Ib clinical study.

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 name	Pytotinib
Sponsor	Sun Yat-sen University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Advanced Non-small Cell Lung Cancer (PHASE1, 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:

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

Frequently asked questions about Pytotinib

What is Pytotinib?

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

Who makes Pytotinib?

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

What development phase is Pytotinib in?

Pytotinib is in Phase 1.

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

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