Last reviewed 2026-06-03 · How we verify

JS107 for Injection

Shanghai Junshi Bioscience Co., Ltd. · Phase 3 active Small molecule Under review

JS107 for Injection is a PD-L1 inhibitor Small molecule drug developed by Shanghai Junshi Bioscience Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (under investigation).

JS107 is a monoclonal antibody that targets and blocks PD-L1, enhancing anti-tumor immune responses by releasing the brakes on T-cell activation.

JS107 for Injection is being studied in combination with other treatments for Gastric Adenocarcinoma and Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. The mechanism of JS107 for Injection is currently unknown.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	JS107 for Injection
Sponsor	Shanghai Junshi Bioscience Co., Ltd.
Drug class	PD-L1 inhibitor
Target	PD-L1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

JS107 binds to programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing interaction with PD-1 on T cells. This blockade restores T-cell proliferation, activation, and anti-tumor cytotoxic function. The mechanism is designed to overcome tumor immune evasion and promote durable anti-tumor immunity.

Approved indications

Non-small cell lung cancer
Other solid tumors (under investigation)

Common side effects

Fatigue
Decreased appetite
Immune-related adverse events (pneumonitis, hepatitis, colitis)
Infusion-related reactions

Key clinical trials

JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. (PHASE3)

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:

JS107 for Injection CI brief — competitive landscape report
JS107 for Injection updates RSS · CI watch RSS
Shanghai Junshi Bioscience Co., Ltd. portfolio CI

Frequently asked questions about JS107 for Injection

What is JS107 for Injection?

JS107 for Injection is a PD-L1 inhibitor drug developed by Shanghai Junshi Bioscience Co., Ltd., indicated for Non-small cell lung cancer, Other solid tumors (under investigation).

How does JS107 for Injection work?

JS107 is a monoclonal antibody that targets and blocks PD-L1, enhancing anti-tumor immune responses by releasing the brakes on T-cell activation.

What is JS107 for Injection used for?

JS107 for Injection is indicated for Non-small cell lung cancer, Other solid tumors (under investigation).

Who makes JS107 for Injection?

JS107 for Injection 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 JS107 for Injection in?

JS107 for Injection belongs to the PD-L1 inhibitor class. See all PD-L1 inhibitor drugs at /class/pd-l1-inhibitor.

What development phase is JS107 for Injection in?

JS107 for Injection is in Phase 3.

What are the side effects of JS107 for Injection?

Common side effects of JS107 for Injection include Fatigue, Decreased appetite, Immune-related adverse events (pneumonitis, hepatitis, colitis), Infusion-related reactions.

What does JS107 for Injection target?

JS107 for Injection targets PD-L1 and is a PD-L1 inhibitor.

Drug class: All PD-L1 inhibitor drugs
Target: All drugs targeting PD-L1
Manufacturer: Shanghai Junshi Bioscience Co., Ltd. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer
Indication: Drugs for Other solid tumors (under investigation)

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