Benralizumab Approved Naked monospecific

Antibody Information

Entry ID	90
INN	Benralizumab
Status	Approved
Drug code(s)	KHK4563, BIW-8405, MEDI-563
Brand name	FASENRA, 凡舒卓
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-5R alpha
Indications of clinical studies	Atopic dermatitis, Eosinophilic Esophagitis, Asthma, Chronic Obstructive Pulmonary Disease
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)	Approved EU, US, Japan, China, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 15, 2006
Start of Phase 2
Start of Phase 3	September 01, 2013
Date BLA/NDA submitted to FDA	November 16, 2016
Year of first approval (global)	2017
Date of first US approval	November 14, 2017
INN, US product name	Benralizumab
US or EU approved indications	Asthma (add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype); intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (US approval on April 26, 2019)

Description/comment

Low/no fucose (POTELLIGENT technology)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Kyowa Hakko Kirin
Licensee/Partner	AstraZeneca
Comments about company or candidate	Aug 2024: AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma. Approved in US November 14, 2017; approved in EU Jan 10, 2018 Two Phase 3 studies in asthma started in Sep 2013
Full address of company	Tokyo, Japan Asia Japan https://www.kyowakirin.com/index.html