Ripertamab Approved Naked monospecific

Antibody Information

Entry ID	145
INN	Ripertamab
Status	Approved
Drug code(s)	SCT400
Brand name	Anpingxi®
mAb sequence source	mAb chimeric
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	CD20
Indications of clinical studies	Non-Hodgkin's lymphoma
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)	May 15, 2012
Start of Phase 2	May 15, 2015
Start of Phase 3	June 15, 2016
Date BLA/NDA submitted to FDA
Year of first approval (global)	2022
Date of first US approval
INN, US product name	Ripertamab
US or EU approved indications	None

Company information

Company	Sinocelltech Ltd
Licensee/Partner	CSPC Pharmaceutical Group Ltd
Comments about company or candidate	Approved by NMPA for newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin's lymphoma in August 2022. July 2021: Sinocelltech website indicates that State Drug Administration has accepted the listing application. Mar 2019: CSPC Pharmaceutical in-licenses SCT 400 from Sinocelltech Oct 2018: Phase-III clinical trials in Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in China (IV) NCT02772822 Phase 3 study Comparing the Efficiency and Safety of S-CHOP(Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone) Versus R-CHOP in Untreated CD20(Cluster of Differentiation Antigen 20)-Positive DLBCL Patients has not been updated since first posted in May 2016.
Full address of company	No. 31, Kechuang 7th Street, Beijing Economic and Technological Development Zone Asia China http://www.sinocelltech.com/

Description/comment

immunoglobulin G1-kappa, anti-[Homo sapiens MS4A1 (membrane-spanning 4-domains subfamily A member 1, CD20)], chimeric monoclonal antibody

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None