Last reviewed 2026-05-26 · How we verify

ZG2001 Tosilate Tablets

Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

ZG2001 Tosilate Tablets is a Small molecule drug developed by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. It is currently in Phase 1 development. Also known as: ZG2001.

ZG2001 Tosilate Tablets are a small molecule intervention being studied in a Phase I/II clinical trial for the treatment of KRAS mutation-related solid tumors. The study aims to evaluate the tolerability, safety, efficacy, and pharmacokinetics of ZG2001 Tosilate Tablets in participants with KRAS mutated advanced solid tumors.

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	ZG2001 Tosilate Tablets
Also known as	ZG2001
Sponsor	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours (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:

ZG2001 Tosilate Tablets CI brief — competitive landscape report
ZG2001 Tosilate Tablets updates RSS · CI watch RSS
Suzhou Zelgen Biopharmaceuticals Co.,Ltd portfolio CI

Frequently asked questions about ZG2001 Tosilate Tablets

What is ZG2001 Tosilate Tablets?

ZG2001 Tosilate Tablets is a Small molecule drug developed by Suzhou Zelgen Biopharmaceuticals Co.,Ltd.

Who makes ZG2001 Tosilate Tablets?

ZG2001 Tosilate Tablets is developed by Suzhou Zelgen Biopharmaceuticals Co.,Ltd (see full Suzhou Zelgen Biopharmaceuticals Co.,Ltd pipeline at /company/suzhou-zelgen-biopharmaceuticals-co-ltd).

Is ZG2001 Tosilate Tablets also known as anything else?

ZG2001 Tosilate Tablets is also known as ZG2001.

What development phase is ZG2001 Tosilate Tablets in?

ZG2001 Tosilate Tablets is in Phase 1.

Manufacturer: Suzhou Zelgen Biopharmaceuticals Co.,Ltd — full pipeline
Also known as: ZG2001

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