Gensci-048, Ginalimb, Genakumab, Genalumab (not WHO-assigned names) Regulatory review TBD

Antibody Information

Entry ID	656
INN	None
Status	Regulatory review
Drug code(s)	Gensci-048, Ginalimb, Genakumab, Genalumab (not WHO-assigned names)
Brand name	(Pending)
mAb sequence source	mAb - source TBD
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)	IL-1 beta
Indications of clinical studies	Juvenile Idiopathic Arthritis, Solid tumors, acute gout
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)	Regulatory review China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	April 22, 2019
Start of Phase 2	May 22, 2021
Start of Phase 3	January 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	Changchun GeneScience Pharmaceutical Co., Ltd.
Licensee/Partner	None
Comments about company or candidate	On April 11 2024, Changchun GeneScience Pharmaceuticals Co., Ltd. (GenSci) received the "Acceptance Notice" from the National Medical Products Administration (NMPA), signaling the acceptance of their marketing application for GenSci's Genakumab. This development is auspicious, as Genakumab's indication for acute gouty arthritis has been recognized. NCT05983445 Phase 3 study in gout started in Jan 2023. Phase 2 studies for gout: NCT05936268 is recruiting as of July 11, 2023, NCT05936281 is not yet recruiting. Phase 2 study for Active Systemic Juvenile Idiopathic Arthritis NCT05925452 is not yet recruiting as of July 7, 2023. NCT05925452 Phase 1 in juvenile RA due to start in July 2023. NCT05894148 Phase 1 in healthy subjects started in March 2023. NCT05441046 Phase 1 is solid tumors started in June 2022.
Full address of company	No. 72 Tianhe Street, Changchun High-Tech Industrial Development Zone, Changchun, Jilin Province, China, Postal code: 130012 Asia China https://en.gensci-china.com/contactus.html

Description/comment

None

Additional information

Anticipated events	Regulatory review China - anticipate approval
Factor(s) contributing to discontinuation	None