Bosakitug Clinical Naked monospecific

Antibody Information

Entry ID	473
INN	Bosakitug
Status	Clinical
Drug code(s)	BSI-045B, BSI-04502, TQC2731
Brand name	None
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)	TSLP
Indications of clinical studies	Chronic Obstructive Pulmonary Disease, Asthma, Atopic dermatitis
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)	October 15, 2021
Start of Phase 2	September 15, 2022
Start of Phase 3	February 20, 2025
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	Biosion
Licensee/Partner	Aclaris Therapeutics, CTTQ
Comments about company or candidate	NCT06829784 / CTR20244307 Phase 3 in asthma start Feb 20, 2025. November 18, 2024 I Biosion, Inc. announced that it has entered into an exclusive license agreement with Aclaris Therapeutics for worldwide rights (excluding Greater China) to BSI-045B. Apr 4 2023 press release: Biosion’s collaboration partner - CTTQ, a China-based pharmaceutical company with rights to BSI-045B (TQC2731) for China development and commercialization, is currently conducting a Phase II clinical trial (CTR20221541) of BSI-045B in China for the treatment of severe uncontrolled asthma. Listed as Phase 2 asset in company pipeline accessed Feb 2023. NCT05114889 Phase 1 in Atopic Dermatitis started in Oct 2021. BSI-045B was created by Biosion under a collaboration with CTTQ in Dec 2017. CTTQ owns Greater China rights while Biosion retains all ex-China rights to develop and commercialize for all indications. Development status: CTTQ is currently conducting a Phase 2 clinical study of BSI-045B in severe asthma in China. Biosion is conducting a Phase 1b clinical study in atopic dermatitis in Australia.
Full address of company	Building D, Zhongdan Unit, Nanjing Jiangbei New Area, China 210061 Asia China https://www.biosion.com/

Description/comment

BSI-045B is an anti-thymic stromal lymphopoietin (TSLP) mAb. BSI-045B is a best-in-class high-affinity humanized anti-TSLP monoclonal antibody with over 150-fold higher in vitro efficacy compared to Tezepelumab (Tezspire™).

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None