Recaticimab Regulatory review Naked monospecific

Antibody Information

Entry ID	1737
INN	Recaticimab
Status	Regulatory review
Drug code(s)	SHR-1209
Brand name	(Pending)
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)	PCSK9
Indications of clinical studies	Hypercholesterolemia, Hyperlipidemia
Primary therapeutic area	Metabolic 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)	August 30, 2018
Start of Phase 2	September 01, 2020
Start of Phase 3	April 20, 2021
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	Recaticimab
US or EU approved indications	None

Company information

Company	Jiangsu HengRui Medicine Co. Ltd
Licensee/Partner	None
Comments about company or candidate	Aug 2023: Listed as NDA filed in Hengrui pipeline Phase 3 studies are currently either completed or active non recruiting: studies for Hypercholesterolemia and hyperlipidemia (NCT04849000 completed in May 19, 2023, NCT04885218 is active non recruiting since May 24, 2022); Primary hypercholesterolemia (NCT04844125 completed in April 25, 2023). No recent relevant news on Hengrui website. Aug 2022: No information found regarding plans for NDA/BLA submission. Phase 1b/2 study published in Jan 2022 (BMC Medicine volume 20, Article number: 13 (2022)) NCT04844125 Phase 3 in Primary Hypercholesterolemia started in April 2021 has primary completion date in April 2022. NCT04885218 Phase 3 in Hypercholesterolemia Hyperlipidemia started in June 2021 has primary completion date in October 2023.
Full address of company	No.7 Kunlunshan Road, Lianyungang Eco & Tech Development Zone, Jiangsu, 222000 Asia China https://www.globaldata.com/company-profile/jiangsu-hengrui-medicine-co-ltd/#:~:text=Jiangsu%20Hengrui%20is%20headquartered%20in%20Lianyungang%2C%20Jiangsu%20Province%2C%20China.

Description/comment

immunoglobulin G1-kappa, anti-[Homo sapiens PCSK9 (proprotein convertase subtilisin/kexin type 9, neural apoptosis-regulated convertase 1, NARC1, NARC-1, proproteine convertase 9, PC9)], monoclonal antibody;

Additional information

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