Last reviewed 2026-05-19 · How we verify

SHR-1501 for Injection

Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 3 active Small molecule Under review

SHR-1501 for Injection is a PD-L1 inhibitor Small molecule drug developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (under investigation in phase 3).

SHR-1501 is a recombinant human anti-PD-L1 monoclonal antibody that blocks the interaction between PD-L1 and PD-1/B7-1, thereby releasing immune checkpoint inhibition and enhancing anti-tumor T-cell responses.

SHR-1501 for Injection is being studied in a clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC) that is unresponsive to BCG treatment. The study compares the combination of SHR-1501 with BCG to investigator-selected chemotherapy in patients with NMIBC.

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	SHR-1501 for Injection
Sponsor	Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Drug class	PD-L1 inhibitor
Target	PD-L1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

By binding to PD-L1 on tumor cells and immune cells, SHR-1501 prevents the engagement of PD-L1 with its receptors on T cells, which normally suppresses immune activation. This blockade restores T-cell proliferation, activation, and cytotoxic function, allowing the immune system to recognize and attack cancer cells more effectively. The drug is designed to enhance endogenous anti-tumor immunity across multiple cancer types.

Approved indications

Non-small cell lung cancer
Other solid tumors (under investigation in phase 3)

Common side effects

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

Key clinical trials

A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC (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:

SHR-1501 for Injection CI brief — competitive landscape report
SHR-1501 for Injection updates RSS · CI watch RSS
Suzhou Suncadia Biopharmaceuticals Co., Ltd. portfolio CI

Frequently asked questions about SHR-1501 for Injection

What is SHR-1501 for Injection?

SHR-1501 for Injection is a PD-L1 inhibitor drug developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd., indicated for Non-small cell lung cancer, Other solid tumors (under investigation in phase 3).

How does SHR-1501 for Injection work?

What is SHR-1501 for Injection used for?

SHR-1501 for Injection is indicated for Non-small cell lung cancer, Other solid tumors (under investigation in phase 3).

Who makes SHR-1501 for Injection?

SHR-1501 for Injection is developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (see full Suzhou Suncadia Biopharmaceuticals Co., Ltd. pipeline at /company/suzhou-suncadia-biopharmaceuticals-co-ltd).

What drug class is SHR-1501 for Injection in?

SHR-1501 for Injection belongs to the PD-L1 inhibitor class. See all PD-L1 inhibitor drugs at /class/pd-l1-inhibitor.

What development phase is SHR-1501 for Injection in?

SHR-1501 for Injection is in Phase 3.

What are the side effects of SHR-1501 for Injection?

Common side effects of SHR-1501 for Injection include Fatigue, Decreased appetite, Nausea, Immune-related adverse events (pneumonitis, hepatitis, colitis).

What does SHR-1501 for Injection target?

SHR-1501 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: Suzhou Suncadia Biopharmaceuticals 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 in phase 3)

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