Last reviewed 2026-05-28 · How we verify

TAE plus P53 gene

Shenzhen SiBiono GeneTech Co.,Ltd · Phase 2 active Small molecule ✓ Verified May 2026

TAE plus P53 gene is a Small molecule drug developed by Shenzhen SiBiono GeneTech Co.,Ltd. It is currently in Phase 2 development.

TAE plus P53 gene therapy is being studied for the treatment of Advanced Hepatocellular Carcinoma (HCC) and Diabetes, according to ClinicalTrials.gov. The P53 gene is a tumor suppressor gene, and its therapy is being investigated as a small molecule intervention, as per ChEMBL.

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	TAE plus P53 gene
Sponsor	Shenzhen SiBiono GeneTech Co.,Ltd
Modality	Small molecule
Phase	Phase 2

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.

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:

TAE plus P53 gene CI brief — competitive landscape report
TAE plus P53 gene updates RSS · CI watch RSS
Shenzhen SiBiono GeneTech Co.,Ltd portfolio CI

Frequently asked questions about TAE plus P53 gene

What is TAE plus P53 gene?

TAE plus P53 gene is a Small molecule drug developed by Shenzhen SiBiono GeneTech Co.,Ltd.

Who makes TAE plus P53 gene?

TAE plus P53 gene is developed by Shenzhen SiBiono GeneTech Co.,Ltd (see full Shenzhen SiBiono GeneTech Co.,Ltd pipeline at /company/shenzhen-sibiono-genetech-co-ltd).

What development phase is TAE plus P53 gene in?

TAE plus P53 gene is in Phase 2.

Manufacturer: Shenzhen SiBiono GeneTech Co.,Ltd — full pipeline

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