MedPath

SCTB-14

Generic Name
SCTB-14

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Oct 14, 2025

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]

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.