Last reviewed · How we verify
HLX208
HLX208 is a monoclonal antibody targeting PD-1.
HLX208 is a monoclonal antibody targeting PD-1. Used for Non-small cell lung cancer, PD-L1 positive.
At a glance
| Generic name | HLX208 |
|---|---|
| Also known as | BRAF V600E inhibitor |
| Sponsor | Shanghai Henlius Biotech |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
By binding to PD-1, HLX208 blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby releasing the brakes on T-cell activation and proliferation, leading to enhanced anti-tumor immune responses.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pyrexia
Key clinical trials
- Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects (PHASE1)
- Mass Balance Study of [14C]HLX208 in China Healthy Subjects (PHASE1)
- The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation (PHASE1, PHASE2)
- The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment (PHASE2)
- HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors (PHASE1)
- The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation (PHASE2)
- The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation (PHASE2)
- A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation (PHASE1, 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:
- HLX208 CI brief — competitive landscape report
- HLX208 updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI