Last reviewed 2026-04-23 · How we verify

NL003

NL003 is a recombinant human IL-2 mutein that selectively activates IL-2 receptor signaling to enhance immune cell proliferation and anti-tumor activity.

NL003 is a recombinant human IL-2 mutein that selectively activates IL-2 receptor signaling to enhance immune cell proliferation and anti-tumor activity. Used for Advanced solid tumors (Phase 3 development).

At a glance

Mechanism of action

NL003 is an engineered interleukin-2 variant designed to preferentially bind and activate IL-2 receptors on T cells and NK cells while minimizing activation of regulatory T cells. This selective immune activation aims to enhance anti-tumor immunity with potentially improved tolerability compared to wild-type IL-2.

Approved indications

• Advanced solid tumors (Phase 3 development)

Common side effects

• Cytokine release syndrome
• Fatigue
• Fever
• Injection site reactions

Key clinical trials

• Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
• Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2) (PHASE3)
• Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1) (PHASE3)
• Angiogenesis and Blood Perfusion Effect of HGF Gene Therapy in PAD Patients (PHASE3)
• Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• NL003 CI brief — competitive landscape report
• NL003 updates RSS · CI watch RSS
• Beijing Northland Biotech. Co., Ltd. portfolio CI