Kangyueda (stapokibart) / CSPC Pharma, Keymed Biosciences - LARVOL DELTA

Stapokibart (CM310): A review in seasonal allergic rhinitis. (PubMed, Am J Otolaryngol) - "Add-on stapokibart is a valuable therapeutic option for adults with SoC-inadequate moderate-to-severe SAR and elevated eosinophils, providing statistically significant improvements in nasal symptoms and quality of life, with an acceptable safety profile."

Journal • Review • Allergic Rhinitis • Immunology • Inflammation • Respiratory Diseases • IL13 • IL4

Stapokibart Shows Safety and Efficacy in Children with Atopic Dermatitis (EMJ Reviews) - "Overall, stapokibart was well tolerated. Mild or moderate adverse events occurred in 68% of participants, with no severe treatment-related reactions and no new safety signals. Importantly, no anti-drug antibodies were detected during the study, suggesting low immunogenicity...By week 8, more than half (53.8%) of children in the higher-weight group and three-quarters (75.0%) in the lower-weight group achieved EASI-75, a benchmark indicating at least a 75% improvement in eczema severity."

P1/2 data • Atopic Dermatitis

Safety and efficacy of stapokibart, an anti-IL-4Rα monoclonal antibody, in children aged 6-11 years with moderate-to-severe atopic dermatitis: An open-label, single-arm phase 1b/2a trial. (PubMed, Br J Dermatol) - P1/2 | "Stapokibart showed potential for improving disease outcomes and appeared to be well tolerated in children aged 6-11 years with moderate-to-severe AD. Larger controlled studies are needed to confirm long-term benefits."

Journal • P1/2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of Anti-IL-4Rα Stapokibart in Elderly Patients With Moderate-To-Severe Atopic Dermatitis. (PubMed, Int J Dermatol) - "Stapokibart was effective and had a favorable safety profile in elderly patients with moderate-to-severe AD."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL4R

ESSNARES: Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome (clinicaltrials.gov) - P=N/A | N=90 | Not yet recruiting | Sponsor: Huazhong University of Science and Technology

New trial • Allergic Rhinitis • Eosinophilia • Immunology • Inflammation

Efficacy and Safety of Stapokibart in Adults With Moderate-to-Severe Atopic Dermatitis With and Without Type 2 Comorbidities: A Post Hoc Analysis of a Phase 3 Trial. (PubMed, Clin Transl Allergy) - P3 | "Stapokibart was effective and safe in adults with moderate-to-severe AD both with and without type 2 comorbidities in both short-term and long-term treatment."

Journal • P3 data • Retrospective data • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Conjunctivitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pruritus • Pulmonary Disease • Respiratory Diseases • Urticaria • IL4R

Comprehensive Management Study of Domestic Innovative Biologic Therapy Combined with Surgery for Type 2 Chronic Rhinosinusitis with Nasal Polyps (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: West China Hospital, Sichuan University; West China Hospital, Sichuan University

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

A prospective, randomized, single-blind, self-controlled study evaluating the efficacy of endoscopic ethmoid infundibulum expansion surgery (EEIES) combined with Stapokibart in the treatment of type 2 chronic rhinosinusitis. (ChiCTR) - P4 | N=60 | Recruiting | Sponsor: China-Japan Friendship Hospital of Jilin University; China-Japan Friendship Hospital of Jilin University

New P4 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Study of CM310 in Adolescent Subjects With Atopic Dermatis (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis (clinicaltrials.gov) - P3 | N=180 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jan 2025 | Trial primary completion date: May 2025 ➔ Jan 2025

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

Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Chengdu Kangnuoxing Biopharma,Inc.

New P3 trial • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology

Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial (EADV 2025) - P3 | "Stapokibart demonstrated significant efficacy and a favorable safety profile in adolescents with moderate-to-severe AD."

Clinical • P3 data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Pruritus • Respiratory Diseases

Successful treatment of pityriasis lichenoides et varioliformis acuta with stapokibart: a case report. (PubMed, Front Med (Lausanne)) - "Following treatment with biological agents, the patient's rash completely resolved, and their quality of life significantly improved, without any adverse reactions. This case provides a valuable reference for the clinical treatment of PLEVA."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Evaluating stapokibart in the treatment of seasonal allergic rhinitis. (PubMed, Immunotherapy) - "Stapokibart has been approved for treating adults with atopic dermatitis, chronic rhinosinusitis with nasal polyposis, and SAR in China. This article reviews the mechanism of action, pharmacology, and available clinical trial data regarding the efficacy and safety of stapokibart in SAR."

Journal • Review • Allergic Rhinitis • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL13 • IL4R

Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis (clinicaltrials.gov) - P=N/A | N=40 | Not yet recruiting | Sponsor: First Affiliated Hospital of Chongqing Medical University

New trial • Amyloidosis • Dermatopathology

Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: The CROWNS-2 Randomized Clinical Trial. (PubMed, JAMA) - P3 | "Four weeks after initiation of mometasone furoate nasal spray, 100 µg in each nostril daily, patients were randomized to receive subcutaneous stapokibart, 300 mg, or placebo (1:1) every 2 weeks for 24 weeks...Among patients with severe chronic rhinosinusitis with nasal polyps treated with a daily intranasal corticosteroid, stapokibart reduced polyp size and severity of nasal symptoms at 24 weeks. ClinicalTrials.gov Identifier: NCT05436275."

Clinical • Journal • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilia • Immunology • Musculoskeletal Pain • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

Targeted Biologic Therapies in Severe Asthma: Mechanisms, Biomarkers, and Clinical Applications. (PubMed, Pharmaceuticals (Basel)) - "Monoclonal antibodies targeting IgE (omalizumab) and IL-5 (mepolizumab, benralizumab, reslizumab, depemokimab) have demonstrated the ability to reduce exacerbation frequency and improve lung function, with newer agents such as depemokimab offering extended dosing intervals. Itepekimab, an anti-IL-33 antibody, effectively engages its target and mitigates tissue eosinophilia, while CM310-stapokibart, tralokinumab, and lebrikizumab inhibit IL-4/IL-13 signaling with variable efficacy depending on patient biomarkers. Comparative analyses of these biologics, encompassing affinity, dosing regimens, and trial outcomes, underscore the imperative of personalized therapy to optimize disease control in severe asthma."

Biomarker • Journal • Review • Asthma • Eosinophilia • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL17A • IL33 • IL4 • IL5

Keymed Biosciences (02162.HK) Reports Strong Interim 2025 Results with Accelerated Commercialization and Robust R&D Momentum (PRNewswire) - "Financially, the company achieved record revenue, driven by the strong performance of its core product, Stapokibart, an IL-4Rα antibody marketed as Kang Yue Da. The drug generated net sales of approximately RMB 170 million."

Sales • Allergic Rhinitis • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Otorhinolaryngology • Sinusitis

A Prospective, Randomized, Single-blind, Self-controlled Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis (clinicaltrials.gov) - P=N/A | N=30 | Enrolling by invitation | Sponsor: China-Japan Union Hospital

New trial • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Stapokibart over 52 weeks: A Post Hoc Analysis of a Phase 3 Trial. (PubMed, Adv Ther) - P3 | "Stapokibart significantly improved PROs in adults with moderate-to-severe AD through 52-week treatment."

Journal • P3 data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Efficacy and Safety of Extending Dosing Interval of Stapokibart in Patients with Atopic Dermatitis. (PubMed, Dermatitis) - P2 | "The overall incidence of treatment-emergent adverse events was 78.6%, mostly mild or moderate. Extending dosing interval of stapokibart based on efficacy response demonstrated sustained efficacy and favorable safety in AD."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL4R

Real-World Efficacy and Safety of STAPOKIBART in the Treatment of Moderate-to-Severe Atopic Dermatitis in Middle-Aged and Elderly Patients (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: Dematology Hospital of Southern Medical University; Dematology Hospital of Southern Medical University

New trial • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/ Metastatic HNSCC ( LONG'E ) (ChiCTR) - P1 | N=10 | Not yet recruiting | Sponsor: Bejing Tongren Hospital, Capital Medical Uniersity; Bejing Tongren Hospital, Capital Medical Uniersity

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

LONG'E: Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Beijing Tongren Hospital

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Stratification Value of Nasal Brushing Arachidonate 15-Lipoxygenase in Stapokibart (CM310) Treatment for Patients with Seasonal Allergic Rhinitis: Results from MERAK (EAACI 2025) - "However, in patients with nasal brushing ALOX15 mRNA level <median, stapokibart did not provide additional benefits compared with placebo. Conclusion In patients with moderate-to-severe uncontrolled SAR, those with higher nasal brushing ALOX15 mRNA levels benefit more from anti-IL-4Rα treatment."

Clinical • Allergic Rhinitis • Immunology • Inflammation • ALOX15