Last reviewed 2026-04-19 · How we verify

Monoclonal antibody BAT6026

Bio-Thera Solutions · Phase 1 active Small molecule

Monoclonal antibody BAT6026 is a Small molecule drug developed by Bio-Thera Solutions. It is currently in Phase 1 development. Also known as: BAT6026.

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	Monoclonal antibody BAT6026
Also known as	BAT6026
Sponsor	Bio-Thera Solutions
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Evaluate the Safety, Tolerability of BAT6026 (PHASE1, PHASE2)
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China (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:

Monoclonal antibody BAT6026 CI brief — competitive landscape report
Monoclonal antibody BAT6026 updates RSS · CI watch RSS
Bio-Thera Solutions portfolio CI

Frequently asked questions about Monoclonal antibody BAT6026

What is Monoclonal antibody BAT6026?

Monoclonal antibody BAT6026 is a Small molecule drug developed by Bio-Thera Solutions.

Who makes Monoclonal antibody BAT6026?

Monoclonal antibody BAT6026 is developed by Bio-Thera Solutions (see full Bio-Thera Solutions pipeline at /company/bio-thera-solutions).

Is Monoclonal antibody BAT6026 also known as anything else?

Monoclonal antibody BAT6026 is also known as BAT6026.

What development phase is Monoclonal antibody BAT6026 in?

Monoclonal antibody BAT6026 is in Phase 1.

Manufacturer: Bio-Thera Solutions — full pipeline
Also known as: BAT6026

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