Vunakizumab Approved Naked monospecific

Antibody Information

Entry ID	1738
INN	Vunakizumab
Status	Approved
Drug code(s)	SHR-1314
Brand name	安达静
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-17A
Indications of clinical studies	Graves' Orbitopathy, Lupus Nephritis, Ankylosing Spondylitis, Plaque Psoriasis, axial spondyloarthritis, Phase 1 in healthy volunteers
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 China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	August 15, 2016
Start of Phase 2	November 09, 2019
Start of Phase 3	June 01, 2021
Date BLA/NDA submitted to FDA
Year of first approval (global)	2024
Date of first US approval
INN, US product name	Vunakizumab
US or EU approved indications	None

Company information

Company	Jiangsu HengRui Medicine Co. Ltd.
Licensee/Partner	Atridia Pty Ltd.
Comments about company or candidate	Approved in China Aug 19 2024. Aug 2023: Listed in Hengrui pipeline as NDA submitted for vunakizumab as a single agent to treat moderate-to-severe plaque psoriasis. Phase 2/3 study for Ankylosing spondylitis status (CTR20210745) is "in progress, recruitment completed" and Phase 3 study for Plaque psoriasis CTR20210753 status is "competed". Mar 2023: Vunakizumab is a phase III humanized monoclonal lgG1 antibody to address IL-17 related autoimmune diseases with fast response and dosing convenience. Two registrational trials are ongoing in China for severe plaque psoriasis and ankylosing spondylitis. More indications are under development. (https://www.hengrui.com/en/pipeline.html) NCT04840485 Phase 2/3 in Ankylosing Spondylitis started in June 2021. NCT04839016 Phase 3 in plaque psoriasis due to start in April 2021. NCT04121143 Phase 2 in plaque psoriasis started in Nov 2019 but suspended in March 2020 (sponsor decision). NCT03710681 Phase 1 in plaque psoriasis started in Aug 2018 still recruiting as of Aug 2019. NCT03704428 Phase 1 study in AS started in April 2018. NCT03463187 Phase 1/2 study in Plaque Psoriasis started in Dec 2017 still recruiting as of Aug 2019. NCT02934412 Phase 1 completed in June 2017. Atridia Pty Ltd (Atridia) is an independent Pharmaceutical company headquartered in Sydney, acting for Jiangsu Hengrui Medicine Co., Ltd.
Full address of company	None Asia China None

Description/comment

immunoglobulin G1-kappa, anti-[Homo sapiens IL17A (interleukin 17A, IL-17A)], humanized monoclonal antibody.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None