Rulonilimab Clinical Naked monospecific

Antibody Information

Entry ID	621
INN	Rulonilimab
Status	Clinical
Drug code(s)	F520
Brand name	None
mAb sequence source	mAb chimeric
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)	PD-1
Indications of clinical studies	Non-small cell lung cancer, cervical carcinoma, Peripheral T Cell Lymphoma, Hepatocellular Carcinoma, Urothelial Cell Carcinoma
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)	March 01, 2019
Start of Phase 2	November 01, 2020
Start of Phase 3	November 01, 2022
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	Shandong New Time Pharmaceutical Co. LTD
Licensee/Partner	None
Comments about company or candidate	NCT05408221 Phase 2/3 study started in Nov 2022 is recruiting as of last update in March 2023. As of March 2022, 4 Phase 2 studies are listed as not yet recruiting, e.g., NCT05178836 Phase 2 in diffuse large B-cell lymphoma due to start in Jan 2022. NCT06226350 Phase 2 in cervical cancer started in Mar 2021. NCT04636515 Phase 2 in Urothelial Carcinoma due to start in January 2021. NCT04457830 Phase 1 in Peripheral T Cell Lymphoma. NCT03657381 Phase 1 study started in March 2019. Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: F520) jointly developed by Shandong New Time Pharmaceutical Co., LTD
Full address of company	No. 209, Hongqi Road, Linyi City, Shandong Province, China Asia China http://lunanpharma.com/contact/

Description/comment

Immune checkpoint target; described as humanized by company

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None