Last reviewed 2026-04-19 · How we verify

Super1 TCR-T

Guangzhou FineImmune Biotechnology Co., LTD. · Phase 1 active Biologic

Super1 TCR-T is a Biologic drug developed by Guangzhou FineImmune Biotechnology Co., LTD.. It is currently in Phase 1 development. Also known as: NY-ESO-1 TCR-T.

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	Super1 TCR-T
Also known as	NY-ESO-1 TCR-T
Sponsor	Guangzhou FineImmune Biotechnology Co., LTD.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors (PHASE1)

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:

Super1 TCR-T CI brief — competitive landscape report
Super1 TCR-T updates RSS · CI watch RSS
Guangzhou FineImmune Biotechnology Co., LTD. portfolio CI

Frequently asked questions about Super1 TCR-T

What is Super1 TCR-T?

Super1 TCR-T is a Biologic drug developed by Guangzhou FineImmune Biotechnology Co., LTD..

Who makes Super1 TCR-T?

Super1 TCR-T is developed by Guangzhou FineImmune Biotechnology Co., LTD. (see full Guangzhou FineImmune Biotechnology Co., LTD. pipeline at /company/guangzhou-fineimmune-biotechnology-co-ltd).

Is Super1 TCR-T also known as anything else?

Super1 TCR-T is also known as NY-ESO-1 TCR-T.

What development phase is Super1 TCR-T in?

Super1 TCR-T is in Phase 1.

Manufacturer: Guangzhou FineImmune Biotechnology Co., LTD. — full pipeline
Also known as: NY-ESO-1 TCR-T

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