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Actemra +MTX
Actemra +MTX is a IL-6 receptor antagonist (monoclonal antibody) Small molecule drug developed by Zhejiang Hisun Pharmaceutical Co. Ltd.. It is currently in Phase 3 development for Rheumatoid arthritis (moderate to severe, in combination with methotrexate).
Actemra (tocilizumab) is an IL-6 receptor antagonist that blocks interleukin-6 signaling to reduce inflammatory responses, used in combination with methotrexate (MTX) for rheumatoid arthritis.
Actemra (tocilizumab) is an IL-6 receptor antagonist that blocks interleukin-6 signaling to reduce inflammatory responses, used in combination with methotrexate (MTX) for rheumatoid arthritis. Used for Rheumatoid arthritis (moderate to severe, in combination with methotrexate).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Actemra +MTX |
|---|---|
| Sponsor | Zhejiang Hisun Pharmaceutical Co. Ltd. |
| Drug class | IL-6 receptor antagonist (monoclonal antibody) |
| Target | IL-6 receptor (IL-6R) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Tocilizumab binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling which is a key driver of inflammation in rheumatoid arthritis. By blocking this pathway, it reduces production of inflammatory cytokines and adhesion molecules. The combination with methotrexate enhances efficacy through complementary immunosuppressive mechanisms.
Approved indications
- Rheumatoid arthritis (moderate to severe, in combination with methotrexate)
Common side effects
- Infection (including serious infections)
- Elevated liver enzymes (ALT/AST)
- Neutropenia
- Hyperlipidemia
- Injection site reactions
- Upper respiratory tract infection
Key clinical trials
- An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis (PHASE2)
- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial (PHASE2)
- A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) (PHASE4)
- A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis (PHASE4)
- A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA) (PHASE4)
- An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy (PHASE3)
- Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of Recombinant Anti-interleukin-6 Receptor Humanized Monoclonal Antibody Injection in Combination With Methotrexate and Jamelor ® in the Treatment of Moderate to Severe Rheumatoid Arthritis (PHASE3)
- PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant (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:
- Actemra +MTX CI brief — competitive landscape report
- Actemra +MTX updates RSS · CI watch RSS
- Zhejiang Hisun Pharmaceutical Co. Ltd. portfolio CI
Frequently asked questions about Actemra +MTX
What is Actemra +MTX?
How does Actemra +MTX work?
What is Actemra +MTX used for?
Who makes Actemra +MTX?
What drug class is Actemra +MTX in?
What development phase is Actemra +MTX in?
What are the side effects of Actemra +MTX?
What does Actemra +MTX target?
Related
- Drug class: All IL-6 receptor antagonist (monoclonal antibody) drugs
- Target: All drugs targeting IL-6 receptor (IL-6R)
- Manufacturer: Zhejiang Hisun Pharmaceutical Co. Ltd. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis (moderate to severe, in combination with methotrexate)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing