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UTAA09 cells for infusion

PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Phase 1 active Biologic ✓ Verified May 2026

UTAA09 cells for infusion is a Biologic drug developed by PersonGen BioTherapeutics (Suzhou) Co., Ltd.. It is currently in Phase 1 development.

UTAA09 cells are a type of autologous human cells used for infusion, specifically in the treatment of relapsed or refractory autoimmune diseases such as Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome, and Rheumatoid Arthritis. The mechanism of action of UTAA09 cells is classified as somatic cell supplemental therapy, according to ChEMBL.

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 nameUTAA09 cells for infusion
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.
ModalityBiologic
PhasePhase 1

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 UTAA09 cells for infusion

What is UTAA09 cells for infusion?

UTAA09 cells for infusion is a Biologic drug developed by PersonGen BioTherapeutics (Suzhou) Co., Ltd..

Who makes UTAA09 cells for infusion?

UTAA09 cells for infusion is developed by PersonGen BioTherapeutics (Suzhou) Co., Ltd. (see full PersonGen BioTherapeutics (Suzhou) Co., Ltd. pipeline at /company/persongen-biotherapeutics-suzhou-co-ltd).

What development phase is UTAA09 cells for infusion in?

UTAA09 cells for infusion is in Phase 1.

Related

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