comekibart (MG-K10) / Mabgeek, China Medical System, Dermavon - LARVOL DELTA

Efficacy and Safety of MG-K10 Administered at 600 mg Every 8 Weeks Versus 300 mg Every 4 Weeks in Chinese Adults With Moderate-to-Severe Atopic Dermatitis: Results of a Randomized Phase 2 Study (EADV 2026) - "Compared to all commercially available anti-IL-4Rα therapeutics, MG-K10 features the longest dosing interval in the induction period. Further large-scale studies are warranted to confirm these findings."

Clinical • Late-breaking abstract • P2 data • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Pruritus • IL13 • IL4

60-Week Efficacy Maintenance and Relapse Control with MG-K10 in Adults with Moderate-to-Severe Atopic Dermatitis: MG-K10 Phase 3 Long-Term Extension Results (EADV 2026) - P3 | "Moreover, no relapse occurred following an 8-week follow-up after treatment completion. Conclusions In adult patients with moderate-to-severe atopic dermatitis, MG-K10 Q4W provides stable long-term therapeutic efficacy, sustain high-level responses following treatment completion, and effectively prevent disease relapse."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • IL4

A Phase 2 Study of MG-K10 in Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New P2 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting ➔ Completed | Trial completion date: Dec 2027 ➔ Apr 2026 | Trial primary completion date: Jul 2027 ➔ Mar 2026

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

Phase Ib/II Study of Preliminary Efficacy, Safety and Pharmacodynamics of MG-K10, a Humanised Monoclonal Antibody Targeting IL-4Rα, in Adult Chinese Patients With Asthma. (PubMed, Clin Exp Allergy) - P1/2 | "MG-K10 was superior to placebo in improving lung function, enhancing asthma control and reducing severe exacerbations in patients with asthma. The once-every-4-week regimen offers extended dosing intervals that may enhance medication adherence."

Journal • P1/2 data • PK/PD data • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL4R

A Study of MG-K10 in Chronic Spontaneous Urticaria (clinicaltrials.gov) - P3 | N=226 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New P3 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

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

CMS (867.HK; 8A8.SG): NDA for the Seasonal Allergic Rhinitis Indication of Class 1 Innovative Drug MG-K10 Accepted in China (The Manila Times) - "MG-K10 has met the primary endpoint in a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial in adult patients with moderate-to-severe seasonal allergic rhinitis. The results of the Phase III study demonstrated that the primary endpoint achieved statistical significance, with significantly superior efficacy compared with the placebo group, and a favorable safety profile."

China filing • Allergic Rhinitis • Immunology

Long-term efficacy and safety of MG-K10 for moderate-to-severe atopic dermatitis: 52-week results from a pivotal phase 3 trial (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ADaggio: A Study to Evaluate the Efficacy and Safety of MG-K10 in Participants Who Have Atopic Dermatitis (clinicaltrials.gov) - P3 | N=498 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

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

MG-K10, a Long-Acting Anti-IL-4 Receptor Alpha Monoclonal Antibody in Adult Patients with Moderate-to-Severe Atopic Dermatitis. (PubMed, Dermatitis) - " MG-K10 demonstrates potential as a long-acting therapeutic option for managing symptoms of moderate-to-severe AD, with favorable safety profile. The preliminary efficacy and safety supported further validation of 300 mg Q4W in phase III trial."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL4 • IL4R

CMS (867.HK; 8A8.SG) NDA for AD Indication of Long-acting Anti-IL-4Rα Humanized Monoclonal Antibody Injection MG-K10 Accepted in China (GlobeNewswire) - "MG-K10 has achieved positive results in a randomized, double-blind, placebo-controlled Phase III clinical study in adults with moderate-to-severe AD..."

China filing • Atopic Dermatitis

China Medical System Announces Mg-K10 Drug Trial Approval By NMPA (TradingView)

New P3 trial • Chronic Spontaneous Urticaria

A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2/3 | N=160 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Allergic Rhinitis • Immunology • Inflammation

Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Prurigo Nodularis

Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma (clinicaltrials.gov) - P3 | N=504 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Trial completion date: Sep 2027 ➔ Jan 2028 | Trial primary completion date: Jun 2027 ➔ Nov 2027

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis (clinicaltrials.gov) - P2/3 | N=160 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New P2/3 trial • Allergic Rhinitis • Immunology • Inflammation

Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma (clinicaltrials.gov) - P3 | N=504 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Chime Biologics Supports Mabgeek to Enter the U.S. Phase III Trials for MG-K10 (PRNewswire) - "Chime Biologics...today announced its continued collaboration with Mabgeek in advancing MG-K10, a potential Best-in-Class therapy, a novel IL-4Rα-targeting antibody drug for atopic dermatitis and asthma, into U.S. Phase III trials. Mabgeek had a successful End of Phase II meeting with the FDA, paving the way for its U.S. market entry. Chime Biologics is committed to enabling Mabgeek in its strategic entry into the U.S. market and will continue to provide comprehensive CMC and regulatory support for the start of the Phase III clinical trials of MG-K10 after the positive End of Phase II meeting with the US FDA."

Commercial • FDA event • Asthma • Atopic Dermatitis

Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects with Prurigo Nodularis (clinicaltrials.gov) - P3 | N=160 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New P3 trial • Immunology • Prurigo Nodularis

China Medical System（00867）Obtained Class 1 Innovative Drug Long-acting Anti-IL-4Rα Monoclonal Antibody MG-K10 (GlobeNewswire) - "China Medical System Holdings Limited...is pleased to announce that on 24 January 2025, the Group through subsidiaries of the Company entered into a Collaboration Agreement with Hunan Mabgeek Biotechnology Co., Ltd. ('Mabgeek Biotechnology') and its subsidiary for Class 1 innovative drug anti-IL-4Rα humanized monoclonal antibody injection MG-K10 ('MG-K10' or the 'Product'). The Group has obtained the co-development right as specifically agreed upon in the Agreement and exclusive commercialization right to the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan Region and Singapore (the 'Territory'); Mabgeek Biotechnology will support the commercialization activities and is responsible for the sale and supply of the Product. The collaboration term is perpetual."

Licensing / partnership • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Prurigo Nodularis

Chime Biologics and Mabgeek Achieve MG-K10 PPQ Milestone, Advancing Atopic Dermatitis and Asthma Therapies Antibody Drug MG-K10 Late-Stage Clinical Trials and Commercialization (PRNewswire) - "Chime Biologics...today announced the successful completion of Process Performance Qualification (PPQ) for MG-K10, a humanized anti-IL-4Rα monoclonal antibody. This milestone propels the Phase III clinical trials for treating Th2-mediated inflammatory diseases such as moderate-to-severe atopic dermatitis (AD), asthma, rhinosinusitis, prurigo nodularis, esophagitis and chronic obstructive pulmonary disease (COPD)."

Clinical • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Inflammation • Prurigo Nodularis

MG-K10-I-002: Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects (clinicaltrials.gov) - P=N/A | N=60 | Active, not recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Trial completion date: Apr 2024 ➔ Aug 2024

Trial completion date

Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects (clinicaltrials.gov) - P=N/A | N=60 | Active, not recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New trial