Comekibart Clinical Naked monospecific

Antibody Information

Entry ID	1002
INN	Comekibart
Status	Clinical
Drug code(s)	MG-K10, BC005
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-4R alpha
Indications of clinical studies	Prurigo nodularis, Atopic Dermatitis, Asthma
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 15, 2022
Start of Phase 2	August 15, 2022
Start of Phase 3	January 05, 2024
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Shanghai Meiji Biotechnology Co Ltd
Licensee/Partner	China Medical System Holdings Limited
Comments about company or candidate	China Medical System Holdings Limited announced 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-4Ra 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. Jan 2025: MG-K10 is in Phase III in AD, asthma and prurigo nodularis. CTR20232813 Phase 3 in AD started in Jan 2024. On June 29, 2023, Maiji Biotech announced that its Phase II clinical study of MG-K10 (comekibart) humanized monoclonal antibody injection for the treatment of patients with moderate to severe atopic dermatitis achieved the primary clinical endpoint. NCT05466877 Phase 2 started in Aug 2022. NCT05382910 Phase 1/2 started in July 2022
Full address of company	Room C, 11th Floor, Shanghai Industrial Investment Building, 18 North Caoxi Road Asia China http://www.shmeiji.com/contact.html

Description/comment

Humanized IgG4 monoclonal antibody that specifically recognizes human IL-4Rα and can effectively block the cytokines IL-4 and IL-13 and their interaction of the coreceptor subunit IL-4Rα, according to http://www.mabgeek.com/index.php?c=show&id=18

Additional information

Anticipated events	BLA possible in AD in 2025
Factor(s) contributing to discontinuation	None