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

Novel Therapeutic Strategies for Atopic Dermatitis: Biomarker Modulation and Clinical Implications. A Systematic Review. (PubMed, Clin Rev Allergy Immunol) - "Dupilumab was the most extensively investigated therapy, followed by tralokinumab, JAK inhibitors, and novel agents such as amlitelimab, stapokibart, and tezepelumab...CCL17 and LDH currently represent the most reliable biomarkers associated with disease severity and treatment response, although their limited specificity restricts clinical applicability. Future research should aim to validate integrated biomarker panels combining immunologic, transcriptomic, and microbiomic data to enable precision medicine approaches in atopic dermatitis management."

Biomarker • Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Stapokibart in the Treatment of Perennial Allergic Rhinitis combined with Asthma: A Prospective, Single-Arm, Single-Center, Open-Label Study (ChiCTR) - P4 | N=34 | Not yet recruiting | Sponsor: The First Affiliated Hospital,Sun Yat-sen University; The First Affiliated Hospital,Sun Yat-sen University

New P4 trial • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of Stapokibart (CM310) in Non-Allergic Rhinitis with Eosinophilia Syndrome (ESSNARES): An Investigator-initiated, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial (ChiCTR) - P=N/A | N=90 | Recruiting | Sponsor: Zhongnan Hospital of Wuhan University; Zhongnan Hospital of Wuhan University

New trial • Allergic Rhinitis • Eosinophilia • Immunology • Inflammation

Exploration of the efficacy and safety of Stapokibart during the peri - operative period of type 2 sinusitis based on a clinical cohort study (ChiCTR) - P=N/A | N=60 | Recruiting | Sponsor: Jiangsu Provincial People's Hospital, The First Affiliated Hospital with NanJing Medical University; Jiangsu Provincial People's Hospital, The First A

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

Successful Treatment with Stapokibart in a Severe Uncontrolled CRSwNP Patient: A Case of Rapid Symptom Resolution After Biologic and Surgical Failures. (PubMed, Ear Nose Throat J) - "This case report describes a 29-year-old male with severe, multirefractory CRSwNP who achieved rapid and sustained remission with stapokibart (CM310), a novel anti-IL-4Rα monoclonal antibody, after failing 2 endoscopic sinus surgeries, omalizumab, and AIT. At 32 weeks, marked reductions in polyp burden, symptom scores (22-item Sinonasal Outcome Test (SNOT-22), Visual Analogue Scale (VAS), nasal congestion score (NCS), total symptom score (TSS)), and serum total IgE were documented. This case highlights stapokibart as a potent therapeutic option capable of inducing significant clinical response where conventional interventions have failed, supporting further investigation into IL-4Rα blockade for treatment-refractory CRSwNP."

Journal • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL13 • IL4

Successful use of stapokibart as a biological therapy for allergic fungal rhinosinusitis: a case report. (PubMed, Front Allergy) - "To present a rare, to our knowledge previously undescribed, case of successful AFRS management using stapokibart (CM310)...The patient reported high satisfaction due to a major improvement in quality of life. This pioneering case demonstrates that stapokibart, a novel anti-IL-4Rα antibody, is a promising and effective treatment for refractory AFRS, showing a rapid onset of action and sustained control of type 2 inflammation."

Journal • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Targeted biologics for chronic rhinosinusitis with nasal polyps: efficacy and safety comparison of eight monoclonal antibodies via network meta-analysis. (PubMed, Rhinology) - "All evaluated biological agents demonstrated efficacy superior to placebo, with IL-4 receptor alpha inhibitors showing the largest and most consistent benefits. All treatments exhibited favorable safety profiles, supporting their use for long-term management of CRSwNP."

Journal • Retrospective data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL4 • IL5 • TSLP

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