MedPath

HS-20093

Generic Name
HS-20093

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Oct 3, 2025

Darleukin (L19IL2): A Comprehensive Monograph on a Tumor-Targeted Immunocytokine

Executive Summary

Darleukin, identified by the research code L19IL2 and the DrugBank ID DB17157, is an investigational, fully-human immunostimulatory biopharmaceutical. It is classified as an immunocytokine, a type of recombinant fusion protein engineered to overcome the limitations of systemic cytokine therapy. Darleukin consists of two key components: the human cytokine interleukin-2 (IL-2) and the human L19 antibody. The L19 antibody moiety is designed to specifically target the extra-domain B (EDB) of fibronectin, a protein isoform that is highly expressed within the tumor microenvironment (TME) and associated with angiogenesis, but is largely absent in healthy, mature tissues. This targeted delivery mechanism is central to Darleukin's therapeutic strategy, enabling the concentration of IL-2's potent immunostimulatory effects directly at the site of disease, thereby enhancing its therapeutic index while mitigating the severe systemic toxicities associated with high-dose, untargeted IL-2 administration.

The mechanism of action involves the selective localization of Darleukin within the tumor stroma, followed by the activation of a robust anti-tumor immune response. The IL-2 payload stimulates the proliferation and activation of tumor-specific cytotoxic CD8+ T lymphocytes and Natural Killer (NK) cells, which are critical effectors in the eradication of cancer cells. Clinical investigations, particularly with intralesional administration, have demonstrated that this localized immune activation can translate into a systemic anti-tumor effect, leading to the regression of non-injected metastatic lesions.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/09/22
Not Applicable
Not yet recruiting
Hansoh BioMedical R&D Company
2025/08/11
Not Applicable
Not yet recruiting
Hansoh BioMedical R&D Company
2025/08/01
Not Applicable
Recruiting
2025/05/09
Phase 1
Not yet recruiting
Jiangsu Hansoh Pharmaceutical Co., Ltd.
2025/04/20
Phase 3
Not yet recruiting
Hansoh BioMedical R&D Company
2025/03/19
Phase 1
Recruiting
2025/02/13
Phase 1
Recruiting
Hansoh BioMedical R&D Company
2024/11/21
Phase 1
Not yet recruiting
Hansoh BioMedical R&D Company
2024/08/13
Phase 1
Recruiting
2024/07/30
Phase 3
Not yet recruiting
Hansoh BioMedical R&D Company

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.