Last reviewed 2026-05-28 · How we verify

YZJ-5053 tablets

Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 3/100

YZJ-5053 tablets is a Small molecule drug developed by Shanghai Haiyan Pharmaceutical Technology Co., Ltd.. It is currently in Phase 1 development. Also known as: SHY-1901.

YZJ-5053 tablets are a small molecule intervention being studied in a Phase 1 clinical trial for the treatment of advanced solid tumors. The study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YZJ-5053 tablets in participants with this condition.

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	YZJ-5053 tablets
Also known as	SHY-1901
Sponsor	Shanghai Haiyan Pharmaceutical Technology 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 Phase 1 Study of YZJ-5053 Tablets in Participants With Advanced Solid Tumors (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:

YZJ-5053 tablets CI brief — competitive landscape report
YZJ-5053 tablets updates RSS · CI watch RSS
Shanghai Haiyan Pharmaceutical Technology Co., Ltd. portfolio CI

Frequently asked questions about YZJ-5053 tablets

What is YZJ-5053 tablets?

YZJ-5053 tablets is a Small molecule drug developed by Shanghai Haiyan Pharmaceutical Technology Co., Ltd..

Who makes YZJ-5053 tablets?

YZJ-5053 tablets is developed by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. (see full Shanghai Haiyan Pharmaceutical Technology Co., Ltd. pipeline at /company/shanghai-haiyan-pharmaceutical-technology-co-ltd).

Is YZJ-5053 tablets also known as anything else?

YZJ-5053 tablets is also known as SHY-1901.

What development phase is YZJ-5053 tablets in?

YZJ-5053 tablets is in Phase 1.

Manufacturer: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. — full pipeline
Also known as: SHY-1901

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