IAH0968 Clinical Naked monospecific

Antibody Information

Entry ID	749
INN	None
Status	Clinical
Drug code(s)	IAH0968
Brand name	None
mAb sequence source	mAb - source TBD
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	HER2
Indications of clinical studies	Gastric cancer, HER2+ colorectal cancer, solid tumors
Primary therapeutic area	Cancer

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 2/3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 06, 2021
Start of Phase 2	March 01, 2023
Start of Phase 3	May 15, 2023
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	SUNHO (China) BioPharmaceutical Co. Ltd., Beijing Sunho Pharmaceutical Co.
Licensee/Partner	None
Comments about company or candidate	NCT06504732 Phase 2/3 in gastric cancer due to start in July 2024. NCT05673512 Phase 2/3 in colorectal cancer started in May 2023. NCT05991518 Phase 1/2 started in Mar 2023 NCT04934514 Phase 1/2 started in July 2021
Full address of company	5 Xingjian Road, Economic and Technological Development Zone, Nanjing City Asia China http://www.sunho-bio.com/en/

Description/comment

Afucosylated https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.e15098

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None