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Research Report
Report on Investigational Agent SCTB-14: A Bispecific PD-1/VEGF Antibody
Executive Summary
SCTB-14 is an intravenously administered, investigational bispecific antibody developed by the Chinese biopharmaceutical company Sinocelltech Group Ltd..[1] As a new molecular entity, it is engineered to simultaneously target two clinically validated pathways in oncology: the immune checkpoint receptor Programmed cell death protein 1 (PD-1) and the pro-angiogenic factor Vascular Endothelial Growth Factor (VEGF).[2] This dual mechanism of action is designed to exert a synergistic anti-tumor effect by concurrently reactivating the patient's T-cell-mediated immune response against cancer cells and inhibiting the formation of new blood vessels that tumors require for growth and metastasis.[1]
The clinical development program for SCTB-14 is advancing rapidly, with a clear strategic focus on non-small cell lung cancer (NSCLC), a leading cause of cancer mortality worldwide. The program is headlined by a pivotal Phase 3 trial in China (CTR20250935) evaluating SCTB-14 plus chemotherapy in patients with EGFR-mutated NSCLC who have progressed on prior tyrosine kinase inhibitor (TKI) therapy—a population with a significant unmet medical need.[2] Further underscoring its ambitious strategy in this indication, Sinocelltech is also planning a Phase 2/3 trial (CTR20251153) that will compare SCTB-14 plus chemotherapy directly against an established PD-1 inhibitor, tislelizumab, plus chemotherapy in the first-line treatment of driver gene-negative NSCLC.[2] Foundational safety and dose-finding studies, including a global Phase 1/2 trial (SCTB14-X101), are underway to support broader development across a range of advanced solid tumors.[4]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/12 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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