B001 Clinical TBD

Antibody Information

Entry ID	359
INN	None
Status	Clinical
Drug code(s)	B001
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	TBD
Format, general category	TBD
Format details	TBD
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	CD20
Indications of clinical studies	Neuromyelitis optica
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 2/3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	March 15, 2018
Start of Phase 2
Start of Phase 3	July 17, 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 Pharmaceuticals Holding
Licensee/Partner	None
Comments about company or candidate	NCT06413654 / CTR20241605 Phase 2/3 in NMO sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd started in July 2024 NCT05145361 in NMO Spectrum Disorder started in April 7, 2022. NCT03332121 Phase 1 in CD20 Positive B Cell Non-Hodgkin's Lymphoma started in March 2018. Prepared for studies as of 2017 (https://www.sphchina.com/attached/files/reportE/180420.pdf)
Full address of company	Shanghai Pharma Biotherapeutics USA Inc. 3545 John Hopkins Ct., Ste 160 San Diego, CA 92121 North America United States of America https://www.sphbio.com/view/contact/contact.html

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None