Rmab, SII Rmab, 17C7 Approved Naked monospecific

Antibody Information

Entry ID	135
INN	None
Status	Approved
Drug code(s)	Rmab, SII Rmab, 17C7
Brand name	RabiShield
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Transgenic mouse (Medarex/BMS)

Therapeutic information

Target(s)	Rabies virus (glycoprotein)
Indications of clinical studies	Rabies virus infection
Primary therapeutic area	Infectious diseases

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 India
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 01, 2007
Start of Phase 2
Start of Phase 3
Date BLA/NDA submitted to FDA
Year of first approval (global)	2016
Date of first US approval
INN, US product name	Rmab
US or EU approved indications	None

Company information

Company	Serum Institute of India
Licensee/Partner	None
Comments about company or candidate	Approved in India on 31 Dec 2015 (need to confirm date). Approved in India for post-exposure Prophylaxis of rabies Partnership between MassBiologics and Serum Institute of India. Phase 1 study reported in Vaccine. 2012 Nov 26;30(50):7315-20. doi: 10.1016/j.vaccine.2012.09.027.
Full address of company	212/2, Hadapsar, Off Soli Poonawalla Road, Pune 411028 India Asia India https://www.seruminstitute.com/contact_us.php

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None