Last reviewed 2026-05-14 · How we verify

JS203 combined with lenalidomide

Shanghai Junshi Bioscience Co., Ltd. · Phase 2 active Small molecule

JS203 combined with lenalidomide is a PD-1 inhibitor Small molecule drug developed by Shanghai Junshi Bioscience Co., Ltd.. It is currently in Phase 2 development for Relapsed or refractory multiple myeloma.

JS203 is a PD-1 inhibitor

JS203 is a PD-1 inhibitor Used for Relapsed or refractory multiple myeloma.

Likelihood of approval

13.3% 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).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

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	JS203 combined with lenalidomide
Sponsor	Shanghai Junshi Bioscience Co., Ltd.
Drug class	PD-1 inhibitor
Target	PD-1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

JS203 is a humanized monoclonal antibody that binds to PD-1, preventing its interaction with PD-L1 and thereby enhancing T-cell activation and anti-tumor immune response.

Approved indications

Relapsed or refractory multiple myeloma

Common side effects

Fatigue
Nausea
Diarrhea
Vomiting
Anemia

Key clinical trials

JS203 Combination Regimens in 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:

JS203 combined with lenalidomide CI brief — competitive landscape report
JS203 combined with lenalidomide updates RSS · CI watch RSS
Shanghai Junshi Bioscience Co., Ltd. portfolio CI

Frequently asked questions about JS203 combined with lenalidomide

What is JS203 combined with lenalidomide?

JS203 combined with lenalidomide is a PD-1 inhibitor drug developed by Shanghai Junshi Bioscience Co., Ltd., indicated for Relapsed or refractory multiple myeloma.

How does JS203 combined with lenalidomide work?

JS203 is a PD-1 inhibitor

What is JS203 combined with lenalidomide used for?

JS203 combined with lenalidomide is indicated for Relapsed or refractory multiple myeloma.

Who makes JS203 combined with lenalidomide?

JS203 combined with lenalidomide is developed by Shanghai Junshi Bioscience Co., Ltd. (see full Shanghai Junshi Bioscience Co., Ltd. pipeline at /company/shanghai-junshi-bioscience-co-ltd).

What drug class is JS203 combined with lenalidomide in?

JS203 combined with lenalidomide belongs to the PD-1 inhibitor class. See all PD-1 inhibitor drugs at /class/pd-1-inhibitor.

What development phase is JS203 combined with lenalidomide in?

JS203 combined with lenalidomide is in Phase 2.

What are the side effects of JS203 combined with lenalidomide?

Common side effects of JS203 combined with lenalidomide include Fatigue, Nausea, Diarrhea, Vomiting, Anemia.

What does JS203 combined with lenalidomide target?

JS203 combined with lenalidomide targets PD-1 and is a PD-1 inhibitor.

Drug class: All PD-1 inhibitor drugs
Target: All drugs targeting PD-1
Manufacturer: Shanghai Junshi Bioscience Co., Ltd. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Relapsed or refractory multiple myeloma

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