611 / 3SBio - LARVOL DELTA

Efficacy and Safety of SSGJ-611 in Chinese Patients with Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial (EADV 2026) - No abstract available

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=417 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Chinese Children With Moderate to Severe Atopic Dermatitis(AD) (clinicaltrials.gov) - P3 | N=246 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=128 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

611 (Anti-IL-4Rα mAb): Its NDA for moderate-to-severe atopic dermatitis in adults was submitted and accepted in February 2026. (The Manila Times) - "Non-head-to-head comparisons show its overall efficacy is superior to dupilumab."

China filing • Atopic Dermatitis

Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=519 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Nov 2025

Trial completion • Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=124 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P3 | N=243 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=142 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=510 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Trial primary completion date: Sep 2025 ➔ Dec 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=594 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - A phase 2 study of a new humanized anti-IL-4Rα mAb (SSGJ-611) in COPD (ERS 2025) - P2 | "Meanwhile, advent events were comparable across the three groups. Conclusion As a novel anti-IL-4Rα mAb targeting type 2 inflammation, we have preliminarily demonstrated the efficacy and safety of SSGJ-611 in COPD with frequent exacerbation."

Late-breaking abstract • P2 data • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases

Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A randomized, double-blinded, placebo-controlled phase III clinical trial, to evaluate the safety and efficacy of 611(Recombinant anti-IL-4Rα humanized monoclonal antibody) in Chinese adults with moderate to severe chronic obstructive pulmonary disease (COPD) (ChiCTR) - P3 | N=570 | Not yet recruiting | Sponsor: Shenzhen People's Hospital; Shenzhen People's Hospital

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=124 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2024 ➔ Aug 2026 | Trial primary completion date: Aug 2024 ➔ Aug 2026

Enrollment open • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=594 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial. (PubMed, Dermatol Ther (Heidelb)) - P2 | "611 demonstrated a high efficacy and a favorable safety profile in patients with moderate-to-severe AD."

Clinical • Journal • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Pruritus • Respiratory Diseases • IL13

A Study to Evaluate 611 in Patients with Chronic Rhinosinusitis with Nasal Polyps (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Combination therapy • New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of 611 for the treatment of moderate-to-severe atopic dermatitis in adults (BAD 2024) - "611 showed a positive effect in treatment of patients with moderate-to-severe AD in terms of efficacy and safety. 611 has potentially become a promising treatment product targeting IL-4Rα, following on from dupilumab."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pruritus • IL13 • IL4

Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=104 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology