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Omalizumab for injection
Omalizumab for injection is a Monoclonal antibody Biologic drug developed by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.. It is currently in Phase 3 development for Moderate to severe persistent asthma, Chronic idiopathic urticaria.
Omalizumab is a monoclonal antibody that targets the IgE molecule, preventing it from binding to its receptor on mast cells and basophils.
Omalizumab is an antibody that inhibits the Ig epsilon chain C region, used to treat conditions such as asthma and chronic spontaneous urticaria. It is administered via injection and has been studied in clinical trials in combination with corticosteroids for the treatment of these conditions.
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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 | Omalizumab for injection |
|---|---|
| Sponsor | CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. |
| Drug class | Monoclonal antibody |
| Target | IgE |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By blocking the IgE receptor, omalizumab reduces the release of histamine and other mediators from mast cells and basophils, thereby decreasing inflammation and symptoms associated with allergic diseases.
Approved indications
- Moderate to severe persistent asthma
- Chronic idiopathic urticaria
Common side effects
- Injection site reaction
- Headache
- Nausea
- Fatigue
- Muscle pain
Key clinical trials
- A Study to Find a Suitable Dose of Exl-111 for Further Research (PHASE1)
- Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (PHASE2)
- Omalizumab Weight-Based Dosing Efficacy Trial (PHASE2)
- Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients (PHASE3)
- Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects (PHASE1)
- Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection (PHASE1)
- Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps
- EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients (PHASE4)
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:
- Omalizumab for injection CI brief — competitive landscape report
- Omalizumab for injection updates RSS · CI watch RSS
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Omalizumab for injection
What is Omalizumab for injection?
How does Omalizumab for injection work?
What is Omalizumab for injection used for?
Who makes Omalizumab for injection?
What drug class is Omalizumab for injection in?
What development phase is Omalizumab for injection in?
What are the side effects of Omalizumab for injection?
What does Omalizumab for injection target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting IgE
- Manufacturer: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Moderate to severe persistent asthma
- Indication: Drugs for Chronic idiopathic urticaria
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing