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Bioseal
Bioseal is a Biologic drug developed by Guangzhou Bioseal Biotechnology Co., Ltd.. It is currently in Phase 3 development.
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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).
| 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 | Bioseal |
|---|---|
| Sponsor | Guangzhou Bioseal Biotechnology Co., Ltd. |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
- Lung Infection
- Anemia
- Brain Oedema
- Pyrexia
- Arrhythmia
- Pleural Effusion
- Myocardial Infarction
- Ventricular Tachycardia
- Pneumonia
- Atrial Fibrillation
- Hepatic Failure
- Platelet Count Decreased
Key clinical trials
- Effect of Different Root Canal Sealers on Oxidative Stress Markers (NA)
- Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030) (PHASE3)
- Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain (NA)
- Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma. (PHASE2)
- Bioseal Dural Sealing Study BIOS-14-001 (PHASE3)
- The Bioseal Vascular Study (PHASE4)
- Phase IV Bioseal Study in Brain Tumor Surgery (PHASE4)
- Glue Sealing for Patients With Low-Output ECFs (NA)
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:
- Bioseal CI brief — competitive landscape report
- Bioseal updates RSS · CI watch RSS
- Guangzhou Bioseal Biotechnology Co., Ltd. portfolio CI
Frequently asked questions about Bioseal
What is Bioseal?
Who makes Bioseal?
What development phase is Bioseal in?
What are the side effects of Bioseal?
Related
- Manufacturer: Guangzhou Bioseal Biotechnology Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing