Adebrelimab Approved Naked monospecific

Antibody Information

Entry ID	149
INN	Adebrelimab
Status	Approved
Drug code(s)	SHR-1316, HTI-1088
Brand name	Arelili®
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	PD-L1
Indications of clinical studies	Gastric cancer, Breast cancer, Non-small cell lung cancer, 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)	Approved China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	June 26, 2017
Start of Phase 2
Start of Phase 3	January 22, 2021
Date BLA/NDA submitted to FDA
Year of first approval (global)	2023
Date of first US approval
INN, US product name	Adebrelimab
US or EU approved indications	None

Company information

Company	Jiangsu HengRui Medicine Co. Ltd
Licensee/Partner	Atridia Pty Ltd.
Comments about company or candidate	March 7, 2023 notice: Recently Shanghai Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, received the "Drug Registration Certificate" issued by the National Medical Products Administration (NMPA), approving the company's self-developed PD-L1 inhibitor adelbelimab (Arebelimab) ®) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). https://www.hengrui.com/media/detail-309.html Jiangsu Hengrui Medicine website accessed Aug 10, 2022: The NDA of SHR-1316 in combination with chemotherapy for SCLC has been filed to NMPA Atridia is a Sydney based company that serves as the local Sponsor for Jiangsu Hengrui Medicine Co.,Ltd for clinical trials in Australia. NCT04691063 Phase 3 study in SCLC started enrolling by invitation in Jan 2021. NCT04316364 Phase 3 in NSCLC not yet recruiting when first posted on March 20, 2020. NCT04041011 Phase 1 in small cell lung cancer not yet recruting as of Aug 1, 2019. NCT03474289 Phase 1 study started in March 2018 recruiting as of Aug 2018. NCT03133247 Phase 1 started in June 2017.
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

Immune checkpoint target

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None