Last reviewed 2026-05-27 · How we verify

XZP-5955 tablets

Xuanzhu Biopharmaceutical Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

XZP-5955 tablets is a Small molecule drug developed by Xuanzhu Biopharmaceutical Co., Ltd.. It is currently in Phase 1 development.

XZP-5955 tablets are a small molecule intervention being studied in clinical trials for patients with NTRK or ROS1 fusion positive locally advanced or metastatic solid tumors, including non-small cell lung cancer. The mechanism of action of XZP-5955 tablets is currently unknown.

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	XZP-5955 tablets
Sponsor	Xuanzhu Biopharmaceutical 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 XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors (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:

XZP-5955 tablets CI brief — competitive landscape report
XZP-5955 tablets updates RSS · CI watch RSS
Xuanzhu Biopharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about XZP-5955 tablets

What is XZP-5955 tablets?

XZP-5955 tablets is a Small molecule drug developed by Xuanzhu Biopharmaceutical Co., Ltd..

Who makes XZP-5955 tablets?

XZP-5955 tablets is developed by Xuanzhu Biopharmaceutical Co., Ltd. (see full Xuanzhu Biopharmaceutical Co., Ltd. pipeline at /company/xuanzhu-biopharmaceutical-co-ltd).

What development phase is XZP-5955 tablets in?

XZP-5955 tablets is in Phase 1.

Manufacturer: Xuanzhu Biopharmaceutical Co., Ltd. — full pipeline

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