Last reviewed 2026-05-26 · How we verify

ZKAB001 monotherapy

Lee's Pharmaceutical Limited · Phase 1 active Biologic ✓ Verified May 2026

ZKAB001 monotherapy is a Biologic drug developed by Lee's Pharmaceutical Limited. It is currently in Phase 1 development.

ZKAB001 is a monoclonal antibody that targets and inhibits the programmed cell death 1 ligand 1 (PD-L1). It is being studied as a monotherapy for local progression or metastatic melanoma with failed first-line treatment.

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	ZKAB001 monotherapy
Sponsor	Lee's Pharmaceutical Limited
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase Ib/II Clinical Study of Pexa-Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Combined With Recombinant Whole Human Anti-PD-L1 Monoclonal Antibody (ZKAB001) in Metastatic Melanoma (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:

ZKAB001 monotherapy CI brief — competitive landscape report
ZKAB001 monotherapy updates RSS · CI watch RSS
Lee's Pharmaceutical Limited portfolio CI

Frequently asked questions about ZKAB001 monotherapy

What is ZKAB001 monotherapy?

ZKAB001 monotherapy is a Biologic drug developed by Lee's Pharmaceutical Limited.

Who makes ZKAB001 monotherapy?

ZKAB001 monotherapy is developed by Lee's Pharmaceutical Limited (see full Lee's Pharmaceutical Limited pipeline at /company/lee-s-pharmaceutical-limited).

What development phase is ZKAB001 monotherapy in?

ZKAB001 monotherapy is in Phase 1.

Manufacturer: Lee's Pharmaceutical Limited — full pipeline

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