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HLX15-IV
HLX15-IV is a PD-L1 inhibitor Small molecule drug developed by Shanghai Henlius Biotech. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (under investigation).
HLX15-IV is a humanized monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.
HLX15-IV is a small molecule being studied in clinical trials for various blood cancers, including multiple myeloma, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, and recurrent multiple myeloma. It is being compared to Darzalex in combination with lenalidomide-dexamethasone in a study for transplant-ineligible patients with newly diagnosed multiple myeloma.
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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.
| 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 | HLX15-IV |
|---|---|
| Sponsor | Shanghai Henlius Biotech |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HLX15-IV targets programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing the suppressive signal that tumors use to evade the immune system. By blocking PD-L1, the drug allows T cells to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors and is designed to enhance endogenous anti-tumor immunity.
Approved indications
- Non-small cell lung cancer
- Other solid tumors (under investigation)
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
Key clinical trials
- Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial (PHASE2)
- Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) (PHASE2, PHASE3)
- Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma (PHASE1, PHASE2)
- 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (PHASE1)
- A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma (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:
- HLX15-IV CI brief — competitive landscape report
- HLX15-IV updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI
Frequently asked questions about HLX15-IV
What is HLX15-IV?
How does HLX15-IV work?
What is HLX15-IV used for?
Who makes HLX15-IV?
What drug class is HLX15-IV in?
What development phase is HLX15-IV in?
What are the side effects of HLX15-IV?
What does HLX15-IV target?
Related
- Drug class: All PD-L1 inhibitor drugs
- Target: All drugs targeting PD-L1
- Manufacturer: Shanghai Henlius Biotech — 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