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

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

Stapokibart for severe uncontrolled chronic rhinosinusitis with nasal polyps: multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial (EAACI 2025) - No abstract available

Clinical • P3 data • Immunology

Study on the Treatment of Prurigo Nodularis With Stapokibart Injection (clinicaltrials.gov) - P3 | N=200 | Active, not recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Active, not recruiting | N=150 ➔ 200

Enrollment change • Enrollment closed • Immunology • Prurigo Nodularis

Stapokibart Rapidly and Consistently Improves the Clinical Signs Across All Body Regions in Adults With Moderate-to-Severe Atopic Dermatitis. (PubMed, Int J Dermatol) - No abstract available

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

Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial (Nature) - P3 | N=108 | PHECDA (NCT05908032) | Sponsor: Keymed Biosciences Co.Ltd | "The primary endpoint was mean change from baseline in daily reflective total nasal symptom score (rTNSS) over the first 2 weeks....Compared with the placebo, stapokibart led to a significant improvement in the mean change from baseline in daily rTNSS during the 2-week (least-squares mean difference, −1.3; 95% confidence interval, −2.0 to −0.6; P = 0.0008) and 4-week (least-squares mean difference, −1.7; 95% confidence interval, −2.5 to −0.8; P = 0.0002) treatments."

P3 data • Allergic Rhinitis

Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial. (PubMed, Nat Med) - P3 | "The results of this trial show that pollen seasonal administration of stapokibart improved both nasal and ocular symptoms and quality of life in patients with moderate-to-severe SAR. ClinicalTrials.gov registration: NCT05908032 ."

Clinical • Journal • P3 data • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13 • IL4

The Phase III Study Data of Stapokibart for Seasonal Allergic Rhinitis Published in Nature Medicine (PRNewswire) - P3 | N=108 | PHECDA (NCT05908032) | Sponsor: Keymed Biosciences Co.Ltd | "Keymed Biosciences Inc...announced that the prestigious medical journal Nature Medicine has published the results from the Phase III trial of its independently developed IL-4Rα antibody stapokibart, for the treatment of moderate-to-severe seasonal allergic rhinitis (SAR)....Rapid relief of nasal obstruction：Compared to placebo group, patients in stapokibart group achieved significantly greater improvement in nasal congestion symptom at Day 2. By Day 7, 72% of patients reported clear nasal breathing, with the cumulative response rate rising to 86% at Week 2 and 94% at Week 4. Potent and sustained control of nasal symptoms：Stapokibart demonstrated a 2.7-point reduction in daily reflective total nasal symptom score (rTNSS) from baseline by Day 4, significantly greater than the improvement in the placebo group."

P3 data • Allergic Rhinitis

Long-Term Stapokibart Treatment Induces Sustained Clinical Improvements in Patients With Moderate-to-Severe Atopic Dermatitis. (PubMed, Dermatitis) - P3 | "The patient-reported outcomes also improved sustainedly. Long-term stapokibart treatment induced sustained clinical improvements in adult patients with moderate-to-severe AD, regardless of their initial response to 16-week treatments."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=21 | Not yet recruiting | Sponsor: Sichuan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Stapokibart: First Approval. (PubMed, Drugs) - "Stapokibart is also under clinical evaluation for use in the treatment of moderate-to-severe asthma and chronic obstructive pulmonary disease, and prurigo nodularis. This article summarises the milestones in the development of stapokibart leading to this first approval for moderate-to-severe atopic dermatitis."

Journal • Review • Allergic Rhinitis • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Prurigo Nodularis • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL13 • IL4

Stapokibart (CM310) in patients with uncontrolled seasonal allergic rhinitis (PHECDA): Rationale and design of a multicentre, randomized, double-blind, placebo-controlled study. (PubMed, Asia Pac Allergy) - P3 | "In addition to SoC, which includes mometasone furoate nasal spray and loratadine, participants are randomly assigned using a centralized interactive-web-response-system to receive either subcutaneous Stapokibart 600 (loading dose)-300 mg or a placebo every 2 weeks for 4 weeks. The PHECDA study is for the first time to provide insight into the efficacy and safety of a seasonal add-on Stapokibart for patients with uncontrolled SAR during pollen exposure. NCT05908032."

Clinical • Journal • Allergic Rhinitis • Immunology • Inflammation • IL4R

NMPA APPROVED THE SNDA OF STAPOKIBART FOR THE TREATMENT OF SEASONAL ALLERGIC RHINITIS (HKEXnews) - "The Board of Directors...of the Company is pleased to announce that the National Medical Products Administration (the 'NMPA') of China has recently approved the supplemental New Drug Application (the 'sNDA') of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda...R&D codename: CM310), for the treatment of seasonal allergic rhinitis....The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III study to confirm the efficacy and safety of Stapokibart injection in treatment of adult patients with seasonal allergic rhinitis who are poorly controlled with nasal corticosteroids or other therapies."

China approval • Allergic Rhinitis

A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps (clinicaltrials.gov) - P4 | N=90 | Not yet recruiting | Sponsor: Beijing Tongren Hospital

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

A single center, observational study on the treatment of moderate to severe atopic dermatitis in adults with Stapokibart injection (ChiCTR) - P=N/A | N=20 | Sponsor: Ningbo Traditional Chinese Medicine Hospital; Ningbo Traditional Chinese Medicine Hospital

New trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Keymed Biosciences Announces Approval Of Stapokibart For The Treatment Of Chronic Rhinosinusitis With Nasal Polyposis (PRNewswire) - "Keymed Biosciences Inc...today announced the National Medical Products Administration (the 'NMPA') of China has recently approved the supplemental New Drug Application (the 'sNDA') of Stapokibart...for the treatment of chronic rhinosinusitis with nasal polyposis. The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III clinical study to confirm the efficacy and safety of Stapokibart injection in treatment of patients with chronic rhinosinusitis with nasal polyposis."

China approval • Chronic Rhinosinusitis With Nasal Polyps • Immunology

MIZAR: Study of Stapokibart Injection in Patients With Allergic Rhinitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Allergic Rhinitis • Immunology • Inflammation

The Study of CM310 in Patients With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=127 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Recruiting ➔ Completed | N=459 ➔ 127

Enrollment change • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=500 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Dec 2023

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

Study of CM310 in Patients With Allergic Rhinitis (clinicaltrials.gov) - P2 | N=100 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Dec 2023 | Trial primary completion date: Oct 2024 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date • Allergic Rhinitis • Immunology • Inflammation

The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=46 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Jan 2024 | Trial primary completion date: Mar 2023 ➔ Jan 2024

Trial completion • Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Study of CM310 in Subjects With Allergic Rhinitis (clinicaltrials.gov) - P3 | N=108 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Dec 2023 | Trial primary completion date: May 2024 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date • Allergic Rhinitis • Immunology • Inflammation

A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2） (clinicaltrials.gov) - P3 | N=180 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Completed

Trial completion • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term efficacy and safety of stapokibart for moderate-to-severe atopic dermatitis: 52-week results from a phase 3 trial. (PubMed, Allergy) - P3 | "Long-term treatment with stapokibart demonstrated a sustained efficacy and favorable safety profile in adults with moderate-to-severe AD."

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13 • IL4R

Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Jul 2024 | Initiation date: Mar 2024 ➔ Dec 2023 | Trial primary completion date: Mar 2025 ➔ Jul 2024

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