Finotonlimab Approved Naked monospecific

Antibody Information

Entry ID	1255
INN	Finotonlimab
Status	Approved
Drug code(s)	SCT-I10A, SCTI-10A
Brand name	Yasuhei
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-1
Indications of clinical studies	Esophageal Squamous Cell Carcinoma, Colorectal Cancer, NSCLC, Head and neck 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)	December 13, 2018
Start of Phase 2	October 31, 2019
Start of Phase 3	October 22, 2019
Date BLA/NDA submitted to FDA
Year of first approval (global)	2025
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Sinocelltech Ltd
Licensee/Partner	None
Comments about company or candidate	Feb 2025: Approved in China for Head And Neck Squamous Cell Carcinoma First Line Therapy NDA accepted on Jan 17, 2024 for Patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. NDA accepted on Nov 30, 2023 for Head and Neck Squamous Cell Carcinoma. CTR20201974 and CTR20201976 Phase 2/3 studies in hepatocellular carcinoma in progress Aug 2022: No company news from 2022 on website CTR20220917 Phase 1b started in June 2022. Nov 2020: Phase-II/III clinical trials in Liver cancer (Combination therapy, Late-stage disease, First-line therapy) in China (IV) (NCT04560894) CTR20192593 Phase 3 study in NSCLC started in April 2020. NCT04171284 Phase 3 study started in Oct 2019. NCT04229537 Phase 1 in combination with SCT200 in Esophageal Squamous Cell Carcinoma and Colorectal Cancer not yet recruiting as of Jan 16 2020. NCT04146181 Phase 2 study in head and neck cancer started recruiting on Oct 31, 2019. NCT03821363 Phase 1 study started in Dec 2018.
Full address of company	No. 31, Kechuang 7th Street, Beijing Economic and Technological Development Zone Asia China http://www.sinocelltech.com/

Description/comment

Immune checkpoint target; humanized anti- PD-1 monoclonal antibody

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None