Last reviewed 2026-05-27 · How we verify

SYHX2005

CSPC Ouyi Pharmaceutical Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

SYHX2005 is a Small molecule drug developed by CSPC Ouyi Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.

SYHX2005 is being studied in a Phase I clinical trial for the treatment of patients with advanced solid tumors. The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SYHX2005.

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	SYHX2005
Sponsor	CSPC Ouyi Pharmaceutical 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 Evaluating SYHX2005 in the Treatment of Patients 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:

SYHX2005 CI brief — competitive landscape report
SYHX2005 updates RSS · CI watch RSS
CSPC Ouyi Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about SYHX2005

What is SYHX2005?

SYHX2005 is a Small molecule drug developed by CSPC Ouyi Pharmaceutical Co., Ltd..

Who makes SYHX2005?

SYHX2005 is developed by CSPC Ouyi Pharmaceutical Co., Ltd. (see full CSPC Ouyi Pharmaceutical Co., Ltd. pipeline at /company/cspc-ouyi-pharmaceutical-co-ltd).

What development phase is SYHX2005 in?

SYHX2005 is in Phase 1.

Manufacturer: CSPC Ouyi Pharmaceutical Co., Ltd. — full pipeline

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