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SIBP-01
SIBP-01 is a recombinant hepatitis B vaccine candidate designed to provide immunological protection against hepatitis B virus infection.
SIBP-01 is a recombinant hepatitis B vaccine candidate designed to provide immunological protection against hepatitis B virus infection. Used for Hepatitis B prevention.
At a glance
| Generic name | SIBP-01 |
|---|---|
| Also known as | Herceptin Biosimilar |
| Sponsor | Shanghai Institute Of Biological Products |
| Drug class | Recombinant vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
SIBP-01 appears to be a vaccine formulation developed by Shanghai Institute of Biological Products targeting hepatitis B surface antigen (HBsAg) to stimulate humoral and cellular immune responses. The vaccine aims to induce protective antibodies and T-cell mediated immunity against hepatitis B virus, potentially offering improved immunogenicity or duration of protection compared to existing hepatitis B vaccines.
Approved indications
- Hepatitis B prevention
Common side effects
- Injection site reactions (pain, erythema, swelling)
- Fever
- Fatigue
- Myalgia
Key clinical trials
- Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (PHASE2)
- An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis (PHASE4)
- Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer (PHASE3)
- Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (PHASE2)
- Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers (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:
- SIBP-01 CI brief — competitive landscape report
- SIBP-01 updates RSS · CI watch RSS
- Shanghai Institute Of Biological Products portfolio CI