TQB2102 Clinical ADC, Bispecific, Biparatopic

Antibody Information

Entry ID	1374
INN	None
Status	Clinical
Drug code(s)	TQB2102
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	ADC, Bispecific, Biparatopic
Format, general category	Fragment-Fc conjugate
Format details	scFv-Fc-Fab
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	Cleavable linker
Ave. DAR	None
Conjugated/fused moiety	Topoisomerase I inhibitor
Discovery method/technology	None

Therapeutic information

Target(s)	HER2, HER2
Indications of clinical studies	Gynecological cancers, Gastroesophageal Adenocarcinoma, Non-small cell lung cancer, Biliary Tract Cancer, Breast cancer, Advanced cancer
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)	December 15, 2022
Start of Phase 2	February 15, 2024
Start of Phase 3	October 11, 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	Chia Tai Tianqing Pharmaceutical Group Co. Ltd., Sino Biopharmaceutical
Licensee/Partner	None
Comments about company or candidate	NCT06561607 / CTR20242868 Phase 3 in breast cancer started in Oct 2024. NCT06496490 Phase 2 in NSCLC due to start in July 2024. NCT06431490 Phase 1/2 in biliary tract cancer due to start in July 2024. NCT06198751 / CTR20234259 Phase 2 in breast cancer started in Feb 2024. NCT06115902 Phase 1 in breast cancer due to start in Nov 2023. CTR20230394 Phase 1 in advanced malignancies started in Mar 2023. Listed as Phase 1 asset in company pipeline dated Feb 2023. (http://www.sinobiopharm.com/userfiles/files/tuijiecailiao/Sino%20Biopharm%20-%20JPM%20Deck_final_en.pdf)
Full address of company	Unit 09, 41/F, Office Tower, Convention Plaza, 1 Harbour Road, Wanchai, Hong Kong Asia China https://www.sinobiopharm.com/en/contact-us/#submenu

Description/comment

Innovative drug according to company. TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.
Described in WO2022033578 patent; included in Beacon as bispecific ADC

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None