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SHR-1209
SHR-1209 is a humanized monoclonal antibody that blocks the interaction between PD-L1 and its receptors (PD-1 and B7-1) to enhance anti-tumor immune responses.
SHR-1209 is a humanized monoclonal antibody that blocks the interaction between PD-L1 and its receptors (PD-1 and B7-1) to enhance anti-tumor immune responses. Used for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).
At a glance
| Generic name | SHR-1209 |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
SHR-1209 binds to programmed death ligand-1 (PD-L1) on tumor cells and immune cells, preventing its engagement with PD-1 and B7-1 receptors on T cells. This blockade reverses the immunosuppressive tumor microenvironment, allowing T cells to recognize and attack cancer cells more effectively. The drug is designed to restore anti-tumor immunity in patients with PD-L1-expressing malignancies.
Approved indications
- Non-small cell lung cancer
- Other solid tumors (under investigation in Phase 3)
Common side effects
- Fatigue
- Decreased appetite
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
- Infusion-related reactions
Key clinical trials
- Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers (PHASE1)
- Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia (PHASE3)
- Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage (PHASE3)
- SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research (PHASE3)
- Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers (PHASE1)
- The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia (PHASE1, PHASE2)
- The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects (PHASE1)
- A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia (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:
- SHR-1209 CI brief — competitive landscape report
- SHR-1209 updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI