SHR-A1904 Clinical ADC

Antibody Information

Entry ID	1280
INN	None
Status	Clinical
Drug code(s)	SHR-A1904
Brand name	None
mAb sequence source	mAb humanized
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)	Claudin-18.2
Indications of clinical studies	Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic 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)	January 29, 2021
Start of Phase 2
Start of Phase 3	May 28, 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 Hengrui Pharmaceutical Co. Ltd.
Licensee/Partner	Merck KGaA
Comments about company or candidate	NCT06649292 Phase 3 in gastric cancer started in Nov 2024. CTR20241158 Phase Ib/III clinical study of SHR-A1904 combined with other drugs in the treatment of CLDN18.2-positive advanced solid tumors recruiting as of Sep 9, 2024. October 30, 2023: Merck KGaA announced a strategic collaboration with Jiangsu Hengrui Pharmaceuticals Co. Ltd. (Hengrui). The agreement includes an option to an exclusive license worldwide (ex-China) to develop, manufacture and commercialize Hengrui’s Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904. In addition, Merck KGaA has the option to co-promote the asset in China. NCT05277168 Phase 1/2 started in May 2022 recruiting as of last update in Jan 2023. NCT04928625 is a Phase 1 in pancreatic cancer started in Aug 2021 NCT04877717 is An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors started in July 2021. According to CDE official website,Hengrui Class 1 New Drug"SHR-A1904 for injection"Approved clinical (Acceptance number CXSL2100034); application submitted Jan 29, 2021.
Full address of company	Jiangsu, China Asia China https://www.hengrui.com/en/index.html

Description/comment

SHR-A1904 is a novel ADC comprised of an IgG1 mAb targeting CLDN18.2, a cleavable linker, and a topoisomerase I inhibitor payload.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None