Last reviewed 2026-05-29 · How we verify

SHR1459 ；YY-20394

Jiangsu HengRui Medicine Co., Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

SHR1459 ；YY-20394 is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 2 development.

SHR1459 (YY-20394) is a small molecule being studied in combination with Gemcitabine-Oxaliplatin for the treatment of Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma. This study, known as SHR1459-II-201, is a Phase I/II clinical trial conducted by Jiangsu HengRui Medicine Co., Ltd.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	SHR1459 ；YY-20394
Sponsor	Jiangsu HengRui Medicine Co., Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma (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:

SHR1459 ；YY-20394 CI brief — competitive landscape report
SHR1459 ；YY-20394 updates RSS · CI watch RSS
Jiangsu HengRui Medicine Co., Ltd. portfolio CI

Frequently asked questions about SHR1459 ；YY-20394

What is SHR1459 ；YY-20394?

SHR1459 ；YY-20394 is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd..

Who makes SHR1459 ；YY-20394?

SHR1459 ；YY-20394 is developed by Jiangsu HengRui Medicine Co., Ltd. (see full Jiangsu HengRui Medicine Co., Ltd. pipeline at /company/jiangsu-hengrui-medicine-co-ltd).

What development phase is SHR1459 ；YY-20394 in?

SHR1459 ；YY-20394 is in Phase 2.

Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline

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