SHR-A2009 Clinical ADC

Antibody Information

Entry ID	1283
INN	None
Status	Clinical
Drug code(s)	SHR-A2009
Brand name	None
mAb sequence source	mAb human
General Molecular Category	ADC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	TBD
Linker	Cleavable linker
Ave. DAR	___
Conjugated/fused moiety	Topoisomerase I inhibitor
Discovery method/technology	None

Therapeutic information

Target(s)	HER3
Indications of clinical studies	Non-small cell lung 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 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	August 01, 2021
Start of Phase 2
Start of Phase 3	December 15, 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	Jiangsu HengRui Medicine Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	NCT06671379 / CTR20244118 Phase 3 in NSCLC started in Dec 2024. NCT06474455 Phase 1/2 of SHR-9839 combined with SHR-A2009 in advance solid tumors due to start in June 2024. CTR20233099 Phase IB/II clinical study of SHR-A2009 for injection combined with anti-tumor therapy in patients with advanced solid tumors recruiting as of Jan 2024. NCT06092268 Phase 1/2 in advanced solid tumors due to start in Oct 2023. NCT05394818 Phase 1 started in July 2022; NCT05114759 Phase 1 started in June 2021.
Full address of company	Lianyungang, Jiangsu Province, China. Asia China https://www.hengrui.com/en/about.html

Description/comment

SHR-A2009 is a novel ADC composed of a fully human anti-HER3 IgG1 mAb, cleavable peptide linker and DNA topoisomerase I inhibitor. https://www.hengrui.com/en/pipeline.html; https://www.annalsofoncology.org/article/S0923-7534(23)02681-9/fulltext

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None