YY-20394

Shanghai YingLi Pharmaceutical Co. Ltd. · Phase 2 active Small molecule

YY-20394 is a Small molecule drug developed by Shanghai YingLi Pharmaceutical Co. Ltd.. It is currently in Phase 2 development. Also known as: Linperlisib, Gemcitabine, Oxaliplatin.

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	YY-20394
Also known as	Linperlisib, Gemcitabine, Oxaliplatin
Sponsor	Shanghai YingLi Pharmaceutical 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

• A Study of Linperlisib (YY-20394) in Combination With Rituximab in Patients With Relapsed/Refractory Indolent NHL (PHASE1, PHASE2)
• A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies (PHASE1)
• Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma (PHASE1, PHASE2)
• A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma (PHASE4)
• Real World Study of Linperlisib for Lymphoma Treatment
• A Phase II Study of Linperlisib (YY-20394) in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma (PHASE2)
• SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma (PHASE2)
• A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Thymic Cancer

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:

• YY-20394 CI brief — competitive landscape report
• YY-20394 updates RSS · CI watch RSS
• Shanghai YingLi Pharmaceutical Co. Ltd. portfolio CI

Frequently asked questions about YY-20394

What is YY-20394?

YY-20394 is a Small molecule drug developed by Shanghai YingLi Pharmaceutical Co. Ltd..

Who makes YY-20394?

YY-20394 is developed by Shanghai YingLi Pharmaceutical Co. Ltd. (see full Shanghai YingLi Pharmaceutical Co. Ltd. pipeline at /company/shanghai-yingli-pharmaceutical-co-ltd).

Is YY-20394 also known as anything else?

YY-20394 is also known as Linperlisib, Gemcitabine, Oxaliplatin.

What development phase is YY-20394 in?

YY-20394 is in Phase 2.

Related

• Manufacturer: Shanghai YingLi Pharmaceutical Co. Ltd. — full pipeline
• Also known as: Linperlisib, Gemcitabine, Oxaliplatin