comekibart (MG-K10) / Mabgeek, Guilin SanJin Group, China Medical System - LARVOL DELTA

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

Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis (clinicaltrials.gov) - P3 | N=498 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of MG-K10 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=163 | Active, not recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Trial completion date: Feb 2024 ➔ May 2024

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

Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis (clinicaltrials.gov) - P3 | N=498 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Trial completion date: Feb 2025 ➔ Dec 2025 | Initiation date: Jul 2023 ➔ Dec 2023 | Trial primary completion date: Nov 2024 ➔ Jun 2025

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

Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis (clinicaltrials.gov) - P3 | N=498 | Active, not recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

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

A Study of MG-K10 in Subjects With Asthma (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Trial completion date: Jul 2023 ➔ Jun 2024 | Trial primary completion date: Feb 2023 ➔ Dec 2023

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

A Study of MG-K10 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=163 | Active, not recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of MG-K10 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of MG-K10 in Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

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

A Study of MG-K10 in Subjects With Asthma (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study of MG-K10 in Subjects With Asthma (clinicaltrials.gov) - P1/2 | N=180 | Not yet recruiting | Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

New P1/2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases