Last reviewed 2026-05-27 · How we verify

YS-0N-001

Yisheng Biopharma (Singapore) Pte. Ltd. · Phase 1 active Biologic ✓ Verified May 2026

YS-0N-001 is a Biologic drug developed by Yisheng Biopharma (Singapore) Pte. Ltd.. It is currently in Phase 1 development. Also known as: Polyinosinic-polycytidylic acid/inactivated rabies virus.

YS-0N-001 is a treatment being studied in a clinical trial for patients with advanced solid tumors. The trial, NCT03131765, is a Phase 1 dose escalation and cohort expansion study conducted by Yisheng Biopharma (Singapore) Pte. Ltd.

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	YS-0N-001
Also known as	Polyinosinic-polycytidylic acid/inactivated rabies virus
Sponsor	Yisheng Biopharma (Singapore) Pte. Ltd.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Dose Escalation and Cohort Expansion Study of YS-ON-001 in 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:

YS-0N-001 CI brief — competitive landscape report
YS-0N-001 updates RSS · CI watch RSS
Yisheng Biopharma (Singapore) Pte. Ltd. portfolio CI

Frequently asked questions about YS-0N-001

What is YS-0N-001?

YS-0N-001 is a Biologic drug developed by Yisheng Biopharma (Singapore) Pte. Ltd..

Who makes YS-0N-001?

YS-0N-001 is developed by Yisheng Biopharma (Singapore) Pte. Ltd. (see full Yisheng Biopharma (Singapore) Pte. Ltd. pipeline at /company/yisheng-biopharma-singapore-pte-ltd).

Is YS-0N-001 also known as anything else?

YS-0N-001 is also known as Polyinosinic-polycytidylic acid/inactivated rabies virus.

What development phase is YS-0N-001 in?

YS-0N-001 is in Phase 1.

Manufacturer: Yisheng Biopharma (Singapore) Pte. Ltd. — full pipeline
Also known as: Polyinosinic-polycytidylic acid/inactivated rabies virus

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